53. シェーグレン症候群
[臨床試験数:234,薬物数:270(DrugBank:85),標的遺伝子数:49,標的パスウェイ数:174

Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-003292-22-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
2EUCTR2016-003292-22-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
3EUCTR2016-003292-22-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden
4NCT02962895
(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 PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll195Phase 2United States;Argentina;Austria;Belgium;Chile;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Taiwan;United Kingdom
5EUCTR2016-003292-22-AT
(EUCTR)
19/06/201717/05/2017Study 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 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-003292-22-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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: 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
7EUCTR2016-003292-22-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
8EUCTR2016-003292-22-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Chile;Portugal;United States;Taiwan;Spain;Austria;Russian Federation
9NCT02495129
(ClinicalTrials.gov)
December 20158/7/2015Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's SyndromeA Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CTPrimary Sjögren's SyndromeDrug: VAY736 lower dose;Drug: VAY736 higher doseNovartis PharmaceuticalsNULLWithdrawnN/AN/AAll0Phase 1;Phase 2Netherlands
10NCT02149420
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-000250-22-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