DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 0.005% Lacripep; 0.01% Lacripep; 0.02% Fm, SH; 0.02% Fm, SH, 0.05% CsA; 0.02% Fm, SH, AS; 0.9% sodium chloride; 13-valent pneumococcal conjugate vaccine; 1643368-58-4; 18F-FDG; 23-valent pneumococcal polysaccharide vaccine; 552-02; ABATACEPT; ABBV-323; ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED; AMG 557/MEDI5872; AS; ASCs; Abatacept; Abatacept Placebo; Abatacept SC; Acycloguanosine; Alginate; Allogeneic Mesenchymal Stem Cells (AlloMSC); Allogeneic Stem Cell Transplant; Allogeneic adipose tissue-derived stromal/stem cells; Aloe vera; Anti-CD28dAb; Anti-CD28dab; Anti-pandemic H1N1 influenza vaccine; Artificial Saliva; Autologous Serum 20%; Autologous Serum 50%; Autologous Stem Cell Transplant; Autologous serum; Aún no establecido; B / Phuket / 3073/2013-like virus); BELIMUMAB; BENLYSTA; BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO; BMS-188667; BMS-931699; BMS-986142; BMS-986195; BMS986142; BMS986195; BTK Inhibitor; BUPI5; BUPIVACAINE HYDROCHLORIDE; Baminercept; Belimumab; Benlysta; Benlysta (Belimumab); Biopsy of the labial salivary gland; Blood sample; Branebrutinib; Bupivacaine; Bupizenge; CDZ173; CFZ533; CFZ533 (iscalimab); CFZ533 active - Cohort 1; CFZ533 active - Cohort 2; CFZ533 active - Cohort 3; CFZ533 active -Cohort 3; CICLOSPORIN; CO; CSCC_ASC(22); Calcium; Calcium carbonate; Calcium carbonate D; Carbomer; Carbomer 974P; Carbonate; Cathepsin S; Cathepsin S Inhibitor; Cathepsin S inhibitor; Cellulose; Cevimeline; Chloride; Ciclosporin; Citric Acid based Mouthwash; Citric acid; Coconut; Cryostor CS10; CsA; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cyclosporins; Dehydroepiandrosterone; Dexamethasone; Dexamethasone Parotid Irrigation; Diquafosol; Dornase alfa; E4; EFALIZUMAB; Efalizumab; Endura; Estetrol; Etanercept; FILGOTINIB; FMP-30; Filgotinib; GS-4059; GS-6034; GS-9876; GSK2618960; GSK2618960 2 mg/kg; Gadoterate; Ginseng; Glycyrrhiza; Gold; HGS1006, LymphoStat-B; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HYDROCORTISONE SODIUM PHOSPHATE; HYDROXYCHLOROQUINE; HrIL-2 active; Hyaluronate; Hyaluronic acid; Hydrocortisone; Hydroxychloroquine; IL-2; ISCALIMAB; Ianalumab; Iguratimod; Ikervis; Impact; Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; Iscalimab; KCT-0809 ophthalmic solution; Korean Red Ginseng; LEFLUNOMIDE; LO2A eye drops; LOU064; LY3090106; Lacryvisc; Lanraplenib; Leflunomide; Leflunomide Mylan; Leflunomide mylan; Leniolisib; Levocarnitine; Levofloxacin; Licorice; LimphoStat-B; Lipitor®; Liposic; MABTHERA; MABTHERA - 1 FIALA 500 MG 50 ML; MEDI4920; METILPREDNISOLONE; MabThera; MabThera (Rituximab); MabThera (rituximab); Maxidex; Meglumine; Methotrexate; Methyl cellulose; MighTeaFlow; Mizoribine; Mucosta; Mycophenolate; Mycophenolate mofetil; Mycophenolate sodium; NGX267; NaCl 0,9%; Nivolumab; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; OSE-127; Olive; Olive Oil; Olive oil; Omalizumab; Ophthalmic Emulsion; Orencia; Other: 0.02% Fm, SH, tBCL; Other: No treatment; Other: autologous serum and rebamipide 2%; Other: carboxy methyl cellulose; Other: natural herbs of coconut, aloe vera, and pepperint; P-552; PAH; PARACETAMOLO; PRP injection; Parsaclisib; Phosphate; Pilocarpine; Pilocarpine Hydrochloride; Plaquenil; Prednisone; Privigen 100 mg/ml, solution pour perfusion; Privigen® 100mg/ml at the dose of 2g/kg of body weight; Probiotic Product - Cap; Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine; Procedure: Minor Salivary gland (labial) biopsy; Procedure: Sialoendoscopy; Procedure: pilocarpine; RC18 160 mg; RC18 240 mg; RITUXIMAB; RO545-9072/F03; RO5459072; RSLV-132; Radiation: 11C-MET PET/CT Imaging; Radiation: 18F-FDG PET/CT Imaging; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravagalimab; Rebamipide; Refresh Endura; Remibrutinib; Restasis; Rituxan (US, Canada, Japan), MabThera (rest of world); Rituximab; Rituximab (anti-CD20); Rituximab, Mabthera; S95011; S95011 concentrate for solution for infusion; SALINE; SAR441344; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MEDROL; SS-1; SVS20; Saline; Sandimmun Optoral; Sodium chloride; Sodium hyaluronate; Softacort; Solu-Medrol; Solu-medrol; Standard care Hyaluronic acid eye drops; Sulfate; Systane Ultra UD; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TCM (Gan-Lu-Yin)GLY; Tachipirina; Tacrolimus; Tears Naturale Forte; Tetracycline; Thalidomide; Thymosin Beta 4 eye drops; Thymosin beta 4; Tibulizumab; Tibulizumab (LY3090106); Tirabrutinib; Tocilizumab; Tofacitinib; UCB5857; Ustekinumab; VAY736; VAY736 antibody; VAY736 higher dose; VAY736 lower dose; VIB4920; VIB7734; Vehicle Control; Vitamin A; Vitamin D3; Water; XYZAL - 20 COMPRESSE RI; Xeros; Xylitol; Xyzal; Yellow Fever Vaccine; Yellow Fever vaccine (17D); [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04541589 (ClinicalTrials.gov)	December 18, 2020	14/8/2020	Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome	A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome	Sjögren's Syndrome	Drug: CFZ533 (iscalimab);Other: CFZ533 Placebo	Novartis Pharmaceuticals	NULL	Not yet recruiting	18 Years	90 Years	All	160	Phase 2	NULL
2	EUCTR2020-001942-20-GR (EUCTR)	04/12/2020	12/10/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome	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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United 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
3	EUCTR2020-001942-20-HU (EUCTR)	16/11/2020	17/09/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome	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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United 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
4	EUCTR2018-004476-35-NL (EUCTR)	26/03/2020	13/06/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	United 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
5	EUCTR2018-004476-35-SE (EUCTR)	22/01/2020	02/07/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	Portugal;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
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-004476-35-GB (EUCTR)	07/01/2020	06/06/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	Portugal;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
7	EUCTR2018-004476-35-DE (EUCTR)	22/10/2019	24/06/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	Portugal;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
8	EUCTR2018-004476-35-AT (EUCTR)	26/09/2019	10/07/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	United 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
9	EUCTR2018-004476-35-IT (EUCTR)	10/09/2019	28/04/2020	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	United 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
10	EUCTR2018-004476-35-SI (EUCTR)	06/09/2019	17/09/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	United 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
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2018-004476-35-HU (EUCTR)	07/08/2019	04/06/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	United 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
12	EUCTR2018-004476-35-GR (EUCTR)	07/08/2019	19/06/2019	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome	A 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 AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	Portugal;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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04541589
(ClinicalTrials.gov)

December 18, 2020

14/8/2020

Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome

A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

Sjögren's Syndrome

Drug: CFZ533 (iscalimab);Other: CFZ533 Placebo

Novartis Pharmaceuticals

NULL

Not yet recruiting

18 Years

90 Years

All

160

Phase 2

NULL

EUCTR2020-001942-20-GR
(EUCTR)

04/12/2020

12/10/2020

Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome

A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome

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 AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

United 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

EUCTR2020-001942-20-HU
(EUCTR)

16/11/2020

17/09/2020

Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome

A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: ISCALIMAB

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

EUCTR2018-004476-35-NL
(EUCTR)

26/03/2020

13/06/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

A 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

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-SE
(EUCTR)

22/01/2020

02/07/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

Portugal;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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004476-35-GB
(EUCTR)

07/01/2020

06/06/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-DE
(EUCTR)

22/10/2019

24/06/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-AT
(EUCTR)

26/09/2019

10/07/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-IT
(EUCTR)

10/09/2019

28/04/2020

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-SI
(EUCTR)

06/09/2019

17/09/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004476-35-HU
(EUCTR)

07/08/2019

04/06/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

EUCTR2018-004476-35-GR
(EUCTR)

07/08/2019

19/06/2019

Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 2

Portugal;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