53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

  
179 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05673993
(ClinicalTrials.gov)
April 202329/12/2022A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's SyndromeA Phase ?, Multi-center, Randomized, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Subcutaneous Telitacicept in Subjects With Active Primary Sjogren's SyndromePrimary Sjogren's SyndromeBiological: Telitacicept 80 mg;Biological: Telitacicept 160 mg;Drug: PlaceboRemeGen Co., Ltd.NULLNot yet recruiting18 Years70 YearsAll375Phase 3China
2EUCTR2021-005911-30-NL
(EUCTR)
27/12/202224/10/2022A Study of the safety and effectiveness of Efgartigimod in Patients with Primary Sjögren’s Syndrome (pSS)A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren’s Syndrome Primary Sjögren’s Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10042846;Term: Syndrome Sjogren's;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod alfa
argenx BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Czechia;Hungary;Belgium;Spain;Poland;Germany;Netherlands
3NCT05383677
(ClinicalTrials.gov)
October 1, 202229/3/2022Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's SyndromeANIfrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome - Efficacy and Safety Assessment in a Randomized, Double-blind, Placebo-controlled Phase-IIa Proof-of-concept Trial (ANISE-II)Sjogren's SyndromeDrug: Anifrolumab;Drug: PlaceboUniversity Medical Center GroningenAstraZenecaRecruiting18 YearsN/AAll30Phase 2Netherlands
4NCT05349214
(ClinicalTrials.gov)
August 4, 20228/4/2022Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's SyndromeA Randomized, Double-blind, Placebo Controlled, 3-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-2)Sjogren SyndromeBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll489Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Canada;China;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Lebanon;Mexico;Poland;Romania;Slovakia;Spain;Sweden;Taiwan;United Kingdom
5EUCTR2021-005687-22-SK
(EUCTR)
01/08/202212/05/2022A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndromeA randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 Active Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: IANALUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
489Phase 3United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden
6NCT05350072
(ClinicalTrials.gov)
July 28, 20227/4/2022Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's SyndromeA Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)Sjogren SyndromeBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll285Phase 3United States;Austria;Brazil;China;Czechia;France;Germany;Guatemala;Korea, Republic of;Lithuania;Poland;Portugal;Singapore;Spain;Turkey
7EUCTR2021-005687-22-HU
(EUCTR)
24/05/202211/04/2022A clinical study to investigate ianalumab is effective and safe in the treatment of active Sjögren`s syndromeA randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) - NEPTUNUS-2 Active Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: IANALUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
489Phase 3United States;Taiwan;Slovakia;Greece;Spain;Lebanon;Israel;Chile;Colombia;Italy;India;France;Australia;Peru;South Africa;China;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;Japan;Sweden
8JPRN-jRCT2031210484
30/03/202214/12/2021A Study of Nipocalimab in Adults with Primary Sjogren'sSyndrome (pSS)A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome(pSS) Sjogren's SyndromePlacebo
Placebo infusion will be administered intravenously.

Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.

Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Nishikawa KazukoNULLRecruiting>= 18age old<= 75age oldBoth150Phase 2Germany;Spain;Italy;Netherlands;Poland;Portugal;United States Of America;France;Taiwan;Japan
9EUCTR2021-000665-32-NL
(EUCTR)
16/02/202221/10/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Portugal;France;United States;Taiwan;Spain;Poland;Germany;Netherlands;Italy;Japan
10NCT05113004
(ClinicalTrials.gov)
January 20, 20222/11/2021New Clinical End-points in Patients With Primary Sjögren's SyndromeNEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing PatientsPrimary Sjögren's Syndrome (pSS)Drug: Hydroxychloroquine 400mg/d;Drug: Leflunomide 20mg/d;Drug: Mycophenolate mofetil 2000mg/d;Drug: Placebo of Hydroxychloroquine 400mg/d;Drug: Placebo of Leflunomide 20mg/d;Drug: Placebo of Mycophenolate mofetil 2000mg/dAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll300Phase 2France
11NCT04988087
(ClinicalTrials.gov)
November 30, 202126/7/2021A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled, Parallel Group Basket Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjögren's Syndrome or Mixed Connective Tissue DiseaseSjogren Syndrome;Mixed Connective Tissue DiseaseDrug: MHV370;Drug: PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll30Phase 2China;Germany;Hungary;Poland;Spain;Switzerland;Taiwan;United Kingdom
12NCT03953703
(ClinicalTrials.gov)
November 17, 202130/4/2019Levocarnitine for Dry Eye in Sjogren's SyndromeA Randomized Placebo-controlled, Double Blind Pilot Crossover Trial of Levocarnitine for the Treatment of Keratoconjunctivitis Sicca in Sjogren's SyndromeSjogren's Syndrome;Keratoconjunctivitis SiccaDrug: Levocarnitine;Drug: PlaceboVanderbilt University Medical CenterNULLRecruiting18 Years75 YearsAll15Phase 2United States
13EUCTR2021-000665-32-DE
(EUCTR)
12/11/202127/07/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan
14EUCTR2021-000665-32-IT
(EUCTR)
10/11/202108/09/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: nipocalimab
Product Code: [M281]
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Japan;Italy
15EUCTR2021-000665-32-PT
(EUCTR)
09/11/202116/09/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2France;United States;Portugal;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan
16EUCTR2021-000665-32-ES
(EUCTR)
26/10/202127/08/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS). Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Portugal;France;United States;Taiwan;Poland;Spain;Netherlands;Germany;Italy;Japan
17EUCTR2021-000665-32-PL
(EUCTR)
16/10/202116/09/2021A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: nipocalimab
Other descriptive name: JNJ-80202135
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan
18EUCTR2020-004937-19-ES
(EUCTR)
11/10/202105/08/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Hungary;Taiwan;Poland;Spain;Israel;Germany;United Kingdom;Switzerland;China
19NCT04968912
(ClinicalTrials.gov)
September 21, 20219/7/2021A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)Sjogren's SyndromeOther: Placebo;Drug: Nipocalimab;Drug: Standard of Care TreatmentJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll150Phase 2United States;France;Germany;Italy;Japan;Netherlands;Poland;Portugal;Spain;Taiwan
20EUCTR2020-004937-19-HU
(EUCTR)
21/09/202106/08/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Taiwan;Hungary;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China
21EUCTR2020-004937-19-DE
(EUCTR)
08/09/202129/07/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Hungary;Taiwan;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China
22NCT05005806
(ClinicalTrials.gov)
September 2, 20215/8/2021Fish Oil (Omega 3 ) in Sjogren's SyndromeRandomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome PatientsSjogren's SyndromeDrug: Omega 3 fatty acid;Drug: PlaceboHawler Medical UniversityNULLRecruiting18 Years70 YearsAll100Phase 2/Phase 3Iraq
23NCT04605978
(ClinicalTrials.gov)
August 3, 202119/10/2020Efficacy and Safety of S95011 in Primary Sjögren's Syndrome PatientsA Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled StudyPrimary Sjögren's SyndromeDrug: S95011 concentrate for solution for infusion;Drug: Placebo concentrate for solution for infusionInstitut de Recherches Internationales ServierADIR, a Servier Group companyActive, not recruiting18 Years75 YearsAll48Phase 2United States;Australia;France;Germany;Hungary;Spain;United Kingdom;Canada
24EUCTR2020-003298-22-ES
(EUCTR)
06/07/202109/02/2021A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s SyndromeA randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2France;Hungary;Greece;Poland;Spain;Ukraine;Netherlands;Germany;United Kingdom
25EUCTR2019-002205-22-NL
(EUCTR)
15/06/202111/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom
26NCT04496960
(ClinicalTrials.gov)
May 18, 20212/8/2020Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's SyndromeSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sj(SqrRoot)(Delta)Gren's Syndrome; a Phase Ib-IIa Placebo-controlled Clinical Trial and Associated Mechanistic StudiesSjogren's SyndromeDrug: tofacitinib;Other: PlaceboNational Institute of Dental and Craniofacial Research (NIDCR)NULLRecruiting18 Years75 YearsAll30Phase 1/Phase 2United States
27NCT04793646
(ClinicalTrials.gov)
April 30, 20218/3/2021N-acetylcysteine for Primary Sjögren's SyndromeProspective Randomized, Double-blind Controlled Clinical Study of N-acetylcysteine for Treatment of Dryness Symptoms Due to Primary Sjogren's SyndromeSjögren Syndrome;Sicca SyndromeDrug: N-acetylcysteine syrup;Drug: Placebo syrupUniversity of Sao Paulo General HospitalNULLActive, not recruiting18 YearsN/AFemale60N/ABrazil
28NCT04830644
(ClinicalTrials.gov)
March 22, 202128/3/2021A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.Primary Sjögren SyndromeDrug: Iguratimod;Drug: PlaceboJiangsu Simcere Pharmaceutical Co., Ltd.NULLRecruiting18 Years75 YearsAll144Phase 2China
29EUCTR2018-004387-54-BG
(EUCTR)
09/03/202124/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
30EUCTR2020-003298-22-DE
(EUCTR)
26/02/202126/11/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s SyndromeA randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Greece;Spain;Poland;Ukraine;Germany;United Kingdom
31NCT04684654
(ClinicalTrials.gov)
February 16, 202122/12/2020BMS-986325 in Healthy Participants and Participants With Primary Sjögren's SyndromeA Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Dose Study on the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Subcutaneous and Intravenous BMS-986325 Administration in Healthy Participants and Participants With Primary Sjögren's SyndromeHealthy Participants;Primary Sjögren's SyndromeBiological: BMS-986325;Other: Placebo for BMS-986325Bristol-Myers SquibbNULLRecruiting18 Years75 YearsAll136Phase 1United States;Germany
32EUCTR2020-003298-22-HU
(EUCTR)
10/02/202130/11/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s SyndromeA randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Poland;Ukraine;Netherlands;Germany;United Kingdom;France;Hungary;Greece;Spain
33EUCTR2020-003298-22-GR
(EUCTR)
02/02/202113/12/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s SyndromeA randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Greece;Spain;Poland;Ukraine;Netherlands;Germany;United Kingdom
34NCT04700280
(ClinicalTrials.gov)
January 28, 20216/1/2021A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's SyndromePrimary Sjögren SyndromeDrug: GLPG3970;Drug: PlaceboGalapagos NVNULLActive, not recruiting18 Years74 YearsAll31Phase 2France;Germany;Greece;Hungary;Poland;Spain;Ukraine
35EUCTR2020-001526-59-DE
(EUCTR)
21/01/202103/08/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom
36EUCTR2020-003298-22-FR
(EUCTR)
15/01/202119/11/2020A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s SyndromeA randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Greece;Spain;Poland;Ukraine;Netherlands;Germany;United Kingdom
37JPRN-jRCT2071200072
07/01/202121/12/2020Study of Safety and Tolerability of CFZ533 in Patients With Sjogren's Syndrome (TWINSS Extn)A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjogren's Syndrome Sjogren's Syndrome
Sjogren's Syndrome, autoimmune, ESSDAI, ESSPRI, anti-CD40, CFZ533, iscalimab, TWINSS Extension
Arm 1 - Iscalimab Dose 1
Arm 2 - Iscalimab Dose 2 and Placebo
Yamada HiroyukiNULLRecruiting>= 18age old<= 90age oldBoth16Phase 2Australia;Hungary;Japan
38NCT04541589
(ClinicalTrials.gov)
January 5, 202114/8/2020Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's SyndromeA TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's SyndromeSjögren's SyndromeDrug: CFZ533 (iscalimab);Other: CFZ533 PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years90 YearsAll214Phase 2United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Sweden;Turkey;United Kingdom
39ChiCTR2000037057
2021-01-012020-08-26A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin GranulesA Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules Sjogren syndromeThe first group : The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: 12g of Radix Paeoniae Alba and 6g of raw licorice (2:1) ; The second group:The dosage of Peony and Glycyrrhiza in Jiedu Tongluo Shengjin Granules is: 18g of Radix Paeoniae and 6g of licorice (3 :1); The third group:The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: Radix Paeoniae Alba 30g and raw licorice 6g (5:1);The fourth group:One-tenth of placebo detoxification Tongluo Shengjin granules (white peony 12g licorice 6g);Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1865BothThe first group :30; The second group:30; The third group:30;The fourth group:30;China
40ITMCTR2000003741
2021-01-012020-08-26A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin GranulesA Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules Sjogren syndromeThe first group : The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: 12g of Radix Paeoniae Alba and 6g of raw licorice (2:1) ; The third group:The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: Radix Paeoniae Alba 30g and raw licorice 6g (5:1); The second group:The dosage of Peony and Glycyrrhiza in Jiedu Tongluo Shengjin Granules is: 18g of Radix Paeoniae and 6g of licorice (3 :1);The fourth group:One-tenth of placebo detoxification Tongluo Shengjin granules (white peony 12g licorice 6g);Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1865BothThe first group :30; The third group:30; The second group:30;The fourth group:30;China
41EUCTR2019-002713-19-HU
(EUCTR)
30/12/202002/11/2020A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects with Sjögren’s Syndrome (SS) Sjögren's syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
INN or Proposed INN: Not applicable
Other descriptive name: MEDI4920
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2United States;Taiwan;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Peru;China;Korea, Republic of
42EUCTR2020-000511-77-HU
(EUCTR)
13/11/202022/10/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Taiwan;Hungary;Mexico;Canada;Argentina;Belgium;Spain;Germany;Netherlands;Korea, Republic of
43NCT04572841
(ClinicalTrials.gov)
November 12, 202028/9/2020Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)Sjögren's SyndromeDrug: SAR441344;Drug: PlaceboSanofiNULLRecruiting18 Years80 YearsAll88Phase 2United States;Argentina;Belgium;Canada;Chile;France;Germany;Hungary;Korea, Republic of;Mexico;Spain;Taiwan
44EUCTR2020-000511-77-DE
(EUCTR)
12/11/202024/09/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Hungary;Taiwan;Mexico;Canada;Argentina;Belgium;Spain;Netherlands;Germany;Korea, Republic of
45ChiCTR2000034924
2020-10-302020-07-24Phase I clinical tolerance and pharmacokinetics of TGP capsule in ChinesePhase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese Rheumatoid arthritis, Sjogren's syndromeGroup 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;The Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineNULLPendingBothGroup 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose tolerPhase 1China
46EUCTR2020-001526-59-GB
(EUCTR)
20/10/202014/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom
47EUCTR2020-001526-59-HU
(EUCTR)
06/10/202028/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2France;United States;Hungary;Canada;Spain;Australia;Germany;United Kingdom
48EUCTR2019-002205-22-FR
(EUCTR)
01/10/202013/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
49EUCTR2019-002205-22-DE
(EUCTR)
12/08/202007/07/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
50EUCTR2018-004476-35-RO
(EUCTR)
11/08/202027/04/2022Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
51NCT05269810
(ClinicalTrials.gov)
May 29, 202024/2/2022Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's SyndromeMulticenter Double-blinded Randomized Phase 2a Clinical Trial to Evaluate the Efficacy of SA001 for Dry Eye and Mouth Dryness in the Patients With Primary Sjögren's SyndromePrimary Sjögren's Syndrome (pSS)Drug: SA001 Low dose;Drug: SA001 Mid dose;Drug: SA001 High dose;Drug: PlaceboSamjin Pharmaceutical Co., Ltd.NULLCompleted19 Years80 YearsAll28Phase 2Korea, Republic of
52EUCTR2019-002205-22-BE
(EUCTR)
05/05/202021/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
53EUCTR2019-002205-22-GB
(EUCTR)
01/05/202007/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
54EUCTR2019-002205-22-ES
(EUCTR)
06/04/202023/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
55EUCTR2019-002713-19-IT
(EUCTR)
06/04/202017/06/2021A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren's Syndrome (SS)A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects with Sjögren's Syndrome (SS) - NA Sjögren's syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
Product Code: [NA]
VIELABIO Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2United States;Greece;Spain;Turkey;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Peru;China;Korea, Republic of
56EUCTR2019-002205-22-PL
(EUCTR)
29/03/202007/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom
57EUCTR2018-004476-35-NL
(EUCTR)
26/03/202013/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
58EUCTR2019-002713-19-PL
(EUCTR)
26/02/202022/11/2019A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in subjects with Sjögren’s Syndrome (SS) Sjögren's syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
INN or Proposed INN: Not applicable
Other descriptive name: MEDI4920
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2Argentina;Hungary;United States;United Kingdom;India;Spain;Greece;Turkey;China;Poland;Korea, Republic of;Italy;Mexico;France;Peru
59EUCTR2019-003131-31-NL
(EUCTR)
05/02/202012/12/2019Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's SyndromeA Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren’s Syndrome. Moderately to Severely Active Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ravagalimab
Product Code: ABBV-323
INN or Proposed INN: Ravagalimab
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Netherlands
60EUCTR2018-004476-35-SE
(EUCTR)
22/01/202002/07/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
61EUCTR2019-002713-19-GB
(EUCTR)
15/01/202021/11/2019A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in subjects with Sjögren’s Syndrome (SS) Sjögren's syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
INN or Proposed INN: Not applicable
Other descriptive name: MEDI4920
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2Argentina;Hungary;United States;United Kingdom;India;Greece;Turkey;China;Korea, Republic of;Poland;Italy;Mexico;France;Peru
62NCT04186871
(ClinicalTrials.gov)
January 7, 202028/11/2019Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid ArthritisAutoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's SyndromeDrug: branebrutinib;Drug: abatacept;Drug: branebrutinib placeboBristol-Myers SquibbNULLCompleted18 Years75 YearsAll112Phase 2United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia
63EUCTR2018-004476-35-GB
(EUCTR)
07/01/202006/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
64EUCTR2018-004387-54-GB
(EUCTR)
02/12/201930/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
65NCT04078386
(ClinicalTrials.gov)
November 21, 201918/7/2019A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's SyndromeA Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeBiological: Placebo;Biological: RC18 240 mg;Biological: RC18 160 mgRemeGen Co., Ltd.NULLCompleted18 Years65 YearsAll42Phase 2China
66EUCTR2018-004476-35-DE
(EUCTR)
22/10/201924/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
67EUCTR2018-004387-54-DK
(EUCTR)
21/10/201916/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Estonia;Taiwan;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Belgium;Brazil;Romania;Bulgaria;Germany;Japan
68NCT04129164
(ClinicalTrials.gov)
October 16, 20192/10/2019A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's SyndromeA Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)Sjögren's SyndromeDrug: VIB4920;Drug: PlaceboViela Bio (acquired by Horizon Therapeutics)NULLActive, not recruiting18 Years75 YearsAll183Phase 2United States;Argentina;France;Hungary;India;Italy;Korea, Republic of;Mexico;Peru;Poland;Taiwan;United Kingdom
69NCT03905525
(ClinicalTrials.gov)
October 1, 201925/3/2019Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's SyndromeA 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)Sjögren SyndromeDrug: CFZ533;Other: PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll273Phase 2United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Sweden;Turkey;United Kingdom;Slovenia
70EUCTR2018-004476-35-AT
(EUCTR)
26/09/201910/07/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
71EUCTR2018-004476-35-IT
(EUCTR)
10/09/201928/04/2020Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
72EUCTR2018-004476-35-SI
(EUCTR)
06/09/201917/09/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
260Phase 2Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France
73EUCTR2018-004387-54-BE
(EUCTR)
26/08/201901/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Estonia;Taiwan;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Brazil;Belgium;Romania;Bulgaria;Germany;Japan
74EUCTR2018-004387-54-ES
(EUCTR)
21/08/201908/05/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: Aún no establecido
Product Code: LOU064
INN or Proposed INN: Aún no establecido
Product Code: LOU064
INN or Proposed INN: Aún no establecido
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
252 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China
75EUCTR2018-004476-35-PT
(EUCTR)
19/08/201923/05/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
76EUCTR2018-004476-35-FR
(EUCTR)
13/08/201920/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
77EUCTR2018-004476-35-HU
(EUCTR)
07/08/201904/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Colombia;Argentina;Russian Federation;Romania;Hungary;United States;Japan;United Kingdom;Portugal;Greece;Canada;Austria;Netherlands;Sweden;Turkey;Brazil;Korea, Republic of;Italy;Israel;Slovenia;Australia;Chile;France;Germany
78EUCTR2018-004476-35-GR
(EUCTR)
07/08/201919/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
79NCT04035668
(ClinicalTrials.gov)
July 12, 20198/7/2019A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's SyndromeAn Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)Sjögren SyndromeDrug: Remibrutinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years75 YearsAll73Phase 2United States;Australia;Belgium;Bulgaria;China;Denmark;Germany;Hungary;Spain;Switzerland;Taiwan;United Kingdom
80EUCTR2018-004387-54-HU
(EUCTR)
24/06/201929/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
81NCT03983408
(ClinicalTrials.gov)
June 17, 201910/6/2019Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseImpact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseSjögren's Syndrome;Rheumatic Diseases;Korean Red GinsengDietary Supplement: Korean Red Ginseng;Dietary Supplement: PlaceboHanyang UniversityThe Korean Society of GinsengRecruiting19 Years75 YearsAll120N/AKorea, Republic of
82EUCTR2018-004387-54-DE
(EUCTR)
20/05/201903/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s SyndromeAn adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) Sjögren’s Syndrome (SjS)
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Other descriptive name: LOU064
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
252Phase 2United States;Taiwan;Estonia;Slovakia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;China;Czechia;Turkey;Lithuania;United Kingdom;Hungary;Belgium;Brazil;Romania;Bulgaria;Germany;Japan
83ChiCTR1900021345
2019-02-122019-02-16Effect of Iguratimod on Primary Sjogren's SyndromeObservation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trial Primary Sjogren's SyndromeControl group :Hydrochloroquine;Treatment group:Iguratimod;Tianjin Medical University General HospitalNULLRecruiting1875BothControl group :30;Treatment group:30;China
84EUCTR2017-001371-24-FR
(EUCTR)
08/01/201915/10/2018Intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathiesProspective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies - TINISS Primary Sjögren's syndrome associated painful sensory neuropathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Privigen 100 mg/ml, solution pour perfusionHôpitaux Universitaires de StrasbourgNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
85NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
86EUCTR2016-003558-34-PL
(EUCTR)
19/06/201814/05/2018A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's SyndromeA Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome Active Sjogren’s Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
Other descriptive name: GS-9876
Product Name: tirabrutinib
Product Code: GS-4059
INN or Proposed INN: GS-4059
Other descriptive name: GS-4059
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Spain;Poland;United Kingdom
87EUCTR2016-003292-22-IT
(EUCTR)
20/11/201725/05/2021Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS).A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome. - Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) Primary Sjogren's syndrome.
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: [VAY736]
INN or Proposed INN: IANALUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan
88EUCTR2016-003292-22-PL
(EUCTR)
28/09/201723/08/2017Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Germany;Netherlands;Japan
89NCT03239600
(ClinicalTrials.gov)
September 19, 201719/6/2017A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)A Two Part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren's SyndromeAutoimmune DiseasesDrug: GSK2618960 2 mg/kg;Drug: Placebo;Drug: MethotrexateGlaxoSmithKlineNULLWithdrawn18 Years70 YearsAll0Phase 2United Kingdom
90EUCTR2016-001948-19-IT
(EUCTR)
05/09/201725/05/2021A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sj¿grens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sj¿grens Syndrome - - Adults with moderately to severely Active Primary Sjogrens Syndrome
MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: 00305800
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
288Phase 3Czechia;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Korea, Republic of;Sweden
91EUCTR2016-003292-22-NL
(EUCTR)
25/07/201719/04/2017Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
92EUCTR2016-003292-22-BE
(EUCTR)
17/07/201726/04/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome. Primary Sjogren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ianalumab
Product Code: VAY736
INN or Proposed INN: Ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
93EUCTR2016-003558-34-GB
(EUCTR)
03/07/201702/05/2017A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's SyndromeA Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome Active Sjogren’s Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
Other descriptive name: GS-9876
Product Name: tirabrutinib
Product Code: GS-4059
INN or Proposed INN: GS-4059
Other descriptive name: GS-4059
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Spain;Poland;United Kingdom
94NCT03226444
(ClinicalTrials.gov)
June 30, 201719/7/2017Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's SyndromeA Double-Masked, Randomized, Multi-Center Phase 2 Study to Evaluate the Efficacy and Safety of Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's SyndromePrimary Sjögren Syndrome;Dry EyeDrug: 0.005% Lacripep;Drug: 0.01% Lacripep;Drug: PlaceboTearSolutions, Inc.NULLCompleted18 YearsN/AAll204Phase 1/Phase 2United States
95EUCTR2016-003292-22-HU
(EUCTR)
29/06/201720/04/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;United States;Portugal;Taiwan
96NCT02962895
(ClinicalTrials.gov)
June 27, 20173/11/2016Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)Primary Sjogren SyndromeBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll192Phase 2United States;Argentina;Austria;Belgium;Chile;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Taiwan;United Kingdom
97EUCTR2016-003292-22-AT
(EUCTR)
19/06/201717/05/2017A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
98EUCTR2016-003292-22-FR
(EUCTR)
09/06/201711/04/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
99EUCTR2016-003292-22-DE
(EUCTR)
06/06/201706/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
100EUCTR2016-003292-22-PT
(EUCTR)
05/06/201720/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
101EUCTR2016-003292-22-GB
(EUCTR)
26/05/201720/03/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
102EUCTR2016-003558-34-ES
(EUCTR)
25/05/201708/05/2017A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's SyndromeA Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome Active Sjogren’s Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
Other descriptive name: GS-9876
Product Name: tirabrutinib
Product Code: GS-4059
INN or Proposed INN: GS-4059
Other descriptive name: GS-4059
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Italy;United Kingdom
103NCT03100942
(ClinicalTrials.gov)
May 1, 201731/3/2017Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's SyndromeA Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's SyndromeSjogren's SyndromeDrug: Lanraplenib;Drug: Filgotinib;Drug: Tirabrutinib;Drug: Lanraplenib placebo;Drug: Filgotinib placebo;Drug: Tirabrutinib placeboGilead SciencesGalapagos NV;Ono Pharmaceutical Co. LtdCompleted18 Years75 YearsAll152Phase 2United States;Poland;Spain;United Kingdom
104EUCTR2016-000101-37-GR
(EUCTR)
07/04/201715/03/2017Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's SyndromeA Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study subjects with moderate to severe Sjögren's syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Poland;Belgium;Romania;Peru;Denmark;South Africa;Norway;Netherlands;United States;Greece;Russian Federation;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico
105EUCTR2016-003292-22-ES
(EUCTR)
06/04/201710/03/2017Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome Primary Sjogren’s syndrome
MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
106ChiCTR-INR-16009629
2017-04-012016-10-26A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndromeA double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome primary Sjogren's Syndromelow disease activity-experimental group:Jiedu Tongluo Shengjin prescription;low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription;moderate disease activity-experimental group:prednisone 10mg/d;moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d;moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-control group:prednisone 10mg/d;moderate disease activity-control group:Hydorxychloroquine 0.2g/d;Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese MedicineNULLPending1870Bothlow disease activity-experimental group:27;low disease activity-control group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-conChina
107EUCTR2016-000101-37-IT
(EUCTR)
29/03/201727/02/2018Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's SyndromeA Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study subjects with moderate to severe Sjögren's syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: BTK Inhibitor
Product Code: 1643368-58-4
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Greece;Russian Federation;Chile;Colombia;Italy;United Kingdom;France;Mexico;Poland;Belgium;Romania;Peru;Denmark;South Africa;Netherlands;Norway
108EUCTR2015-000400-26-GB
(EUCTR)
17/03/201714/12/2016A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
109EUCTR2014-004523-51-GR
(EUCTR)
14/02/201703/01/2017UCB Proof of Concept Study in patients with Primary Sjogren’s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME Primary Sjogren’s Syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Italy;United Kingdom;Sweden
110EUCTR2016-001948-19-SE
(EUCTR)
02/02/201719/10/2016A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of
111NCT03247686
(ClinicalTrials.gov)
February 1, 20173/8/2017A Study of RSLV-132 in Subjects With Primary Sjogren's SyndromeA Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's SyndromeSjogren's SyndromeDrug: RSLV-132;Drug: PlaceboResolve TherapeuticsUniversity Hospital Birmingham;Newcastle-upon-Tyne Hospitals NHS TrustCompleted18 Years70 YearsAll28Phase 2United Kingdom
112JPRN-JapicCTI-173521
01/2/201724/02/2017A Phase 3 study of Abatacept in Patients with Primary Sjogrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens Syndrome Primary Sjogrens SyndromeIntervention name : Abatacept
INN of the intervention : Abatacept
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Bristol-Myers Squibb K.K.NULLcomplete18BOTH172Phase 3NULL
113EUCTR2016-001948-19-CZ
(EUCTR)
28/12/201627/10/2016A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
288 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of
114NCT02915159
(ClinicalTrials.gov)
December 6, 201623/9/2016A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens SyndromeSjogrens DiseaseBiological: Abatacept;Other: PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/AAll250Phase 3United States;Argentina;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Sweden;Canada;Czech Republic
115EUCTR2016-001948-19-FR
(EUCTR)
02/12/201607/11/2016A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of
116NCT02503189
(ClinicalTrials.gov)
November 23, 201617/7/2015A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeDrug: KCT-0809 ophthalmic solution;Drug: PlaceboKissei Pharmaceutical Co., Ltd.NULLCompleted20 YearsN/AAllPhase 3Japan
117EUCTR2014-004616-12-PL
(EUCTR)
21/11/201612/10/2016Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome Primary Sjögren's syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
118NCT02843659
(ClinicalTrials.gov)
October 18, 20168/7/2016Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's SyndromeA Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's SyndromeSjögren's SyndromeDrug: BMS-931699;Drug: BMS-986142;Drug: PlaceboBristol-Myers SquibbNULLTerminated18 Years70 YearsAll45Phase 2United States;Australia;Chile;Colombia;Italy;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;France;Hungary
119EUCTR2016-001586-87-GB
(EUCTR)
29/09/201606/07/2016A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s SyndromeA Phase 2, Double Blind, Placebo Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome - RSLV-132 in Primary Sjogren’s Syndrome Primary Sjogrens Syndrome;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: RSLV-132Resolve Therapeutics, LLCNULLNot Recruiting Female: yes
Male: yes
28 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
120EUCTR2014-004616-12-HU
(EUCTR)
28/09/201617/08/2016Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome Primary Sjögren's syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
121EUCTR2015-004476-30-PL
(EUCTR)
26/08/201620/07/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary Sjögren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cathepsin S inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;United Kingdom
122EUCTR2014-004523-51-SE
(EUCTR)
24/08/201605/07/2016UCB Proof of Concept Study in patients with Primary Sjogren’s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME Primary Sjogren’s Syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
123EUCTR2015-004476-30-DE
(EUCTR)
18/07/201618/05/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary Sjögren’s syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cathepsin S Inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;Italy;United Kingdom
124NCT02701985
(ClinicalTrials.gov)
July 5, 20163/3/2016A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's SyndromeA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's SyndromeSjogren's SyndromeDrug: Placebo;Drug: RO5459072Hoffmann-La RocheNULLCompleted18 Years75 YearsAll75Phase 2United States;France;Germany;Poland;Portugal;United Kingdom
125EUCTR2015-004476-30-FR
(EUCTR)
27/06/201604/09/2017A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary Sjögren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cathepsin S
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;United States;France;Poland;Germany;Italy;United Kingdom
126EUCTR2015-004476-30-GB
(EUCTR)
22/06/201616/03/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary Sjögren’s syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cathepsin S inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;France;United States;Poland;Germany;United Kingdom
127EUCTR2015-004476-30-PT
(EUCTR)
15/06/201618/04/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary Sjögren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Cathepsin S inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Portugal;Poland;Germany;United Kingdom
128NCT02775916
(ClinicalTrials.gov)
June 1, 201616/5/2016Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: CDZ173;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll30Phase 2Germany;Hungary
129EUCTR2014-004616-12-DE
(EUCTR)
20/05/201617/03/2016Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome Primary Sjögren's syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CDZ173
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
130NCT04111341
(ClinicalTrials.gov)
May 6, 201626/9/2019A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.Sjögren's SyndromeDrug: TCM (Gan-Lu-Yin)GLY;Drug: PLACEBOChung Shan Medical UniversityNULLCompleted20 Years80 YearsAll30Phase 2Taiwan
131NCT03411850
(ClinicalTrials.gov)
May 201630/6/2016Sjogrens Syndrome Measured by UltrasoundDisease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot StudySjogren's SyndromeBiological: Orencia;Other: PlaceboArthritis & Rheumatism Associates, P.C.Bristol-Myers SquibbActive, not recruiting18 Years65 YearsAll20Phase 2United States
132NCT02631538
(ClinicalTrials.gov)
February 17, 201614/12/2015Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's SyndromeA Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's SyndromeSjogren's SyndromeDrug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximabGlaxoSmithKlineNULLCompleted18 YearsN/AAll86Phase 2Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
133EUCTR2013-004808-19-DE
(EUCTR)
05/02/201607/12/2015Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;Hungary;Germany;United Kingdom;Switzerland
134EUCTR2015-000400-26-IT
(EUCTR)
18/01/201610/11/2020A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML
Product Name: MABTHERA
Product Code: [NA]
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO
Product Name: BENLYSTA
Product Code: [na]
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: SOLU-MEDROL
Product Code: [na]
INN or Proposed INN: METILPREDNISOLONE
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [na]
INN or Proposed INN: PARACETAMOLO
Trade Name: XYZAL - 20 COMPRESSE RI
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
135EUCTR2015-000400-26-NO
(EUCTR)
08/01/201623/09/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden
136EUCTR2015-000400-26-NL
(EUCTR)
28/12/201508/12/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden
137EUCTR2015-000400-26-SE
(EUCTR)
15/12/201508/09/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
138NCT02614716
(ClinicalTrials.gov)
December 10, 201524/11/2015A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's SyndromeSjögren's SyndromeDrug: LY3090106;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years65 YearsAll32Phase 1United States;Bulgaria;Georgia;Romania
139EUCTR2015-000400-26-DE
(EUCTR)
03/12/201501/10/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
140EUCTR2015-000400-26-FR
(EUCTR)
01/12/201524/02/2017A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway
141EUCTR2015-000400-26-ES
(EUCTR)
19/11/201505/10/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. Primary Sjogrens disease
MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
142NCT02610543
(ClinicalTrials.gov)
October 201518/11/2015UCB Proof of Concept Study in Patients With Primary Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: UCB5857;Drug: PlaceboUCB CelltechPRA Health SciencesTerminated18 Years75 YearsAll27Phase 2France;Italy;Spain;Sweden;United Kingdom;Greece
143EUCTR2014-004523-51-ES
(EUCTR)
14/09/201501/06/2015UCB Proof of Concept Study in patients with Primary Sjogren?s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN?S SYNDROME Primary Sjogren?s Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
144EUCTR2014-004523-51-IT
(EUCTR)
25/08/201515/12/2017UCB PROOF OF CONCEPT STUDY IN PATIENTS WITH PRIMARY SJ?GREN'S SYNDROMEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OFCONCEPTSTUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJ?GREN'S SYNDROME - NA Primary Sj?gren's Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB CELLTECH (UK BRANCH OF UCB PHARMA SA)NULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;United Kingdom;Italy;Sweden
145NCT02334306
(ClinicalTrials.gov)
June 8, 201512/12/2014A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's SyndromeA Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeBiological: AMG 557/MEDI5872;Other: PlaceboMedImmune LLCAmgenCompleted18 Years75 YearsAll32Phase 2United States;France;Sweden;United Kingdom
146NCT02464319
(ClinicalTrials.gov)
June 1, 201530/5/2015A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's SyndromeSafety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: hrIL-2 active;Drug: hrIL-2 placeboPeking University People's HospitalMonash University;Beijing ShuangLu Pharmaceutical Co., Ltd.Completed18 Years65 YearsAll60Phase 2China
147EUCTR2014-004523-51-FR
(EUCTR)
28/05/201520/07/2015UCB Proof of Concept Study in patients with Primary Sjogren’s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME Primary Sjogren’s Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
148EUCTR2014-004523-51-GB
(EUCTR)
18/05/201501/04/2015UCB Proof of Concept Study in patients with Primary Sjogren’s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME Primary Sjogren’s Syndrome
MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Italy;United Kingdom;Sweden
149EUCTR2014-003896-41-GB
(EUCTR)
27/03/201505/02/2015MedImmune Sjogren's Syndrome StudyA Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjogren’s Syndrome Primary Sjogren’s Syndrome
MedDRA version: 18.1;Level: LLT;Classification code 10042846;Term: Syndrome Sjogren's;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: AMG 557/MEDI5872
Product Code: AMG 557/MEDI5872
INN or Proposed INN: AMG 557/MEDI5872
MedImmune, LLCNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;United Kingdom;Sweden
150ChiCTR-IPR-15005990
2015-03-232015-02-10Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled TrialCyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial Sjogren's syndromeTreatment group:glucocorticoid+CsA;Control group:glucocorticoid+placebo;Peking University People's HospitalNULLPending1875BothTreatment group:120;Control group:120;China
151NCT02370550
(ClinicalTrials.gov)
March 201518/2/2015Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's SyndromeCyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled TrialSjogren's SyndromeDrug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate DPeking University People's HospitalNULLRecruiting18 Years75 YearsAll240Phase 4China
152NCT02291029
(ClinicalTrials.gov)
October 22, 20144/11/2014Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's SyndromeA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: CFZ533 active - Cohort 1;Drug: CFZ533 placebo- Cohort 1;Drug: CFZ533 active - Cohort 2;Drug: CFZ533 placebo - Cohort 2;Drug: CFZ533 active -Cohort 3;Drug: CFZ533 active - Cohort 3Novartis PharmaceuticalsNULLCompleted18 Years75 YearsAll69Phase 2United States;Germany;Hungary;Switzerland;United Kingdom
153NCT02067910
(ClinicalTrials.gov)
August 201414/2/2014Efficacy and Safety of Abatacept in Patients With Primary Sjögren's SyndromeRandomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome (ASAP III Study = Abatacept Sjögren Active Patients Phase III Study)Sjögren's SyndromeDrug: Abatacept SCUniversity Medical Center GroningenBristol-Myers SquibbCompleted18 YearsN/AAll80Phase 3Netherlands
154EUCTR2013-004808-19-GB
(EUCTR)
23/07/201407/03/2014Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s syndrome
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Germany;Switzerland;United Kingdom
155EUCTR2013-004808-19-HU
(EUCTR)
02/07/201406/05/2014Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s syndrome
MedDRA version: 18.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
INN or Proposed INN: Not yet established
Product Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Hungary;Germany;United Kingdom;Switzerland
156EUCTR2014-000417-31-NL
(EUCTR)
01/07/201420/03/2014Abatacept treatment in primary Sjögrens SyndromeRandomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren’s syndrome(ASAP III study = Abatacept Sjögren Active Patients phase III study) - ASAPIII Primary Sjögren's syndrome (pSS)
MedDRA version: 16.1;Level: LLT;Classification code 10042846;Term: Syndrome Sjogren's;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
157NCT02149420
(ClinicalTrials.gov)
May 23, 20149/9/2013PD of VAY736 in Patients With Primary Sjögren's SyndromeA Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: VAY736;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll27Phase 2Germany;France;Netherlands;United States
158EUCTR2013-000250-22-DE
(EUCTR)
11/04/201416/10/2013A single dose study to assess the effect of VAY736 in patients with primary Sjögren’s syndromeA single dose, double-blind, placebo-controlled, parallel study to assess the pharmacodynamics, pharmacokinetics and safety and tolerability of VAY736 in patients with primary Sjögren’s syndrome - CVAY736X2201 Seropositive primary Sjögren’s syndrome
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: VAY736
Other descriptive name: VAY736
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Germany
159NCT02110446
(ClinicalTrials.gov)
February 20141/4/2014Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's SyndromeEvaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control TrialSjögren's SyndromeDrug: SS-1;Drug: PlaceboChang Gung Memorial HospitalChang Gung University;National Science Council, Taiwan;China Medical University, China;China Medical University HospitalRecruiting20 Years75 YearsBoth60Phase 2Taiwan
160NCT02855658
(ClinicalTrials.gov)
February 201413/7/2016Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's SyndromeModulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's SyndromeSjögren's SyndromeDrug: SS-1;Drug: PlaceboChina Medical University HospitalChang Gung Memorial Hospital;China Medical University, China;National Research Program for Biopharmaceuticals (NRPB)Recruiting20 Years75 YearsBoth90Phase 2Taiwan
161NCT01716312
(ClinicalTrials.gov)
January 8, 201423/10/2012Omalizumab for LupusA Phase 1b, Randomized, Double-Blind, Placebo Controlled Study With an Open Label Extension to Evaluate the Safety and Tolerability of Omalizumab, A Humanized IgG1 Monoclonal Antibody in Patients With Lupus (STOP LUPUS)Systemic Lupus Erthematosus;Sjogren's SyndromeDrug: OmalizumabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years100 YearsAll17Phase 1United States
162NCT01782235
(ClinicalTrials.gov)
July 24, 201330/1/2013Efficacy of Tocilizumab in Primary Sjögren's Syndrome.A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.Primary Sjögren's Syndrome (pSS)Drug: Tocilizumab;Drug: PlaceboUniversity Hospital, Strasbourg, FranceNULLCompleted18 Years80 YearsAll110Phase 2/Phase 3France
163JPRN-UMIN000010710
2013/05/1515/05/2013Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial- - Effective treatment of rebamipide on xerostomia Xerostomia in Sjogrens syndromeRebamipide was administered orally at 100 mg each time three times a day after meals for 8 weeks.
Placebo was administered orally three times a day after meals for 8 weeks.
Tochigi medical centerNULLComplete: follow-up complete20years-old80years-oldMale and Female60Phase 2Japan
164NCT01552681
(ClinicalTrials.gov)
July 20129/3/2012Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)Primary Sjögren's SyndromeBiological: Baminercept;Other: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;BiogenTerminated18 Years75 YearsAll52Phase 2United States
165NCT01584947
(ClinicalTrials.gov)
April 201223/4/2012Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral PainClinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.Chronic PainDrug: Bupivacaine;Drug: PlaceboHvidovre University HospitalOracain II ApsTerminated18 Years75 YearsBoth31Phase 2Denmark
166NCT01601028
(ClinicalTrials.gov)
July 201129/4/2012Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's SyndromePhase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's SyndromeAutoimmune Diseases;Sjogren's Syndrome;Dry EyeDrug: Hydroxychloroquine;Drug: PlaceboSeoul National University HospitalNULLCompleted19 YearsN/ABoth39Phase 3Korea, Republic of
167NCT01316770
(ClinicalTrials.gov)
May 1, 201115/3/2011Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome SubjectsA Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome SubjectsSjögren's Syndrome;XerostomiaDrug: Dexamethasone Parotid Irrigation;Drug: Placebo Parotid IrrigationNational Institute of Dental and Craniofacial Research (NIDCR)NULLTerminated18 YearsN/AFemale14Phase 2United States
168NCT01357447
(ClinicalTrials.gov)
May 201118/5/2011Pulmozyme for Sjogren's Associated CoughA Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated CoughSjogren's Syndrome;CoughDrug: Dornase alfa;Drug: SalineUConn HealthNULLWithdrawn18 YearsN/AAll0Phase 1United States
169EUCTR2010-021430-64-GB
(EUCTR)
03/12/201004/11/2010A clinical trial to show whether there is an improvment in symptoms after the administration of rituximab in patients with primary Sjögren’s syndrome.A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome. - TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0 Primary Sjögren’s syndrome (PSS).
MedDRA version: 14.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: MabThera (rituximab)
Product Name: MabThera (Rituximab)
Product Code: N/A
INN or Proposed INN: Rituximab
Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of world)
University of LeedsNULLNot RecruitingFemale: yes
Male: yes
110United Kingdom
170NCT01369589
(ClinicalTrials.gov)
November 20106/6/2011An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal WetnessAn Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's SyndromeXerostomia;Sjogren's SyndromeDrug: P-552;Drug: PlaceboParion SciencesNULLCompleted18 YearsN/AAll24Phase 1/Phase 2United States
171NCT00852839
(ClinicalTrials.gov)
February 200926/2/2009A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's SyndromeA Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's SyndromeDry Mouth Associated With Sjogren's Syndrome;XerostomiaDrug: Placebo;Drug: 552-02Parion SciencesNULLCompleted18 Years80 YearsAll140Phase 2United States
172NCT00632866
(ClinicalTrials.gov)
March 200829/2/2008Hydroxychloroquine Versus Placebo in Primary Sjögren's SyndromeRandomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: Hydroxychloroquine;Drug: PlaceboAssistance Publique - Hôpitaux de ParisSanofiCompleted18 YearsN/ABoth120Phase 3France
173NCT00637793
(ClinicalTrials.gov)
February 200811/3/2008Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's SyndromeA Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's SyndromeXerostomia;Sjogren's SyndromeDrug: NGX267TorreyPines TherapeuticsNULLCompleted21 Years55 YearsBoth24Phase 2United States
174EUCTR2007-005218-38-FR
(EUCTR)
31/01/200820/11/2007Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUEREssai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER Syndrome de Sjögren primitif
MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Sulfate d'hydroxychloroquine
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
175JPRN-UMIN000000997
2008/01/0128/01/2008The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrateThe non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate - A controlled trial about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate Xerostomia due to Sjogren`s syndromeIt is a gargle with a test drug(Cevimeline hydrochloride hydrate 30mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo1 (Cevimeline hydrochloride hydrate 9mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo2 (Hachiazule(TM)gargle2g+distilled water 50cc)for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out,It is a gargle with false placebo2 for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes.
Department of Dentistry and Oral Surgery, Tochigi National HospitalNational Institute of Public HealthComplete: follow-up complete20years-old90years-oldMale and Female12Phase 1Japan
176NCT00363350
(ClinicalTrials.gov)
August 200610/8/2006Rituximab Treatment in Sjogren's SyndromeRituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled TrialSjogren's SyndromeDrug: rituximab (anti-CD20)University Medical Centre GroningenHoffmann-La RocheCompleted18 Years85 YearsBoth30Phase 1/Phase 2Netherlands
177NCT00344448
(ClinicalTrials.gov)
June 200623/6/2006Pilot Study of Raptiva to Treat Sjogren's SyndromeA Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With Sjogren's SyndromeSjogren's SyndromeDrug: RaptivaNational Institute of Dental and Craniofacial Research (NIDCR)NULLTerminated18 YearsN/AAll10Phase 2United States
178JPRN-JapicCTI-050036
15/4/200506/09/2005Exploratory Study for Dry Mouth in Patients With Sjogren's SyndromeExploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndrome Dry mouth in patients with Sjogren's syndromeIntervention name : Rebamipide
INN of the intervention : Rebamipide
Dosage And administration of the intervention : Oral
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Oral
Otsuka Pharmaceutical Co., Ltd.NULLcomplete20BOTH100Phase 2Japan
179NCT04470479
(ClinicalTrials.gov)
March 1, 20057/7/2020Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens SyndromeOral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens SyndromeDry EyeDrug: Pilocarpine Hydrochloride;Drug: PlaceboFederal University of São PauloNULLCompleted18 Years65 YearsAll32Phase 3Brazil