53. Sjogren syndrome
234 clinical trials,   270 drugs   (DrugBank: 85 drugs),   49 drug target genes,   174 drug target pathways

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"
85 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04496960
(ClinicalTrials.gov)
December 17, 20202/8/2020Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's SyndromeSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome Phase Ib-IIa Placebo-Controlled Clinical Trial and Associated Mechanistic StudiesSjogren's SyndromeDrug: tofacitinib;Other: PlaceboNational Institute of Dental and Craniofacial Research (NIDCR)NULLNot yet recruiting18 Years75 YearsAll30Phase 1;Phase 2United States
2NCT04615455
(ClinicalTrials.gov)
November 3, 20203/11/2020Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's SyndromeA Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's SyndromeKeratoconjunctivitis Sicca, in Sjogren's SyndromeDrug: ASCs;Drug: Cryostor CS10Rigshospitalet, DenmarkNULLRecruiting18 YearsN/AAll40Phase 2Denmark
3EUCTR2019-002205-22-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
4EUCTR2020-002804-38-DK
(EUCTR)
12/08/202016/06/2020A clinical trial in which treatment with stem cells derived from adipose-tissue of healthy donors is tested in patients with reduced tear production due to Sjögren's SyndromeA randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome - AMASS The trial will include participants with Aqueous Deficient Dry Eye Disease due to Sjögrens syndrom (International Classification of Diseases-10: DM 350A)
MedDRA version: 20.0;Level: LLT;Classification code 10023350;Term: Keratoconjunctivitis sicca;System Organ Class: 100000004853;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Allogeneic adipose tissue-derived stromal/stem cells
Product Code: CSCC_ASC(22)
INN or Proposed INN: CSCC_ASC(22)
Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
Rigshospitalet-GlostrupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Denmark
5EUCTR2019-002205-22-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002205-22-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
7EUCTR2019-002205-22-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
8EUCTR2019-002205-22-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;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;Belgium;Poland;Netherlands;Germany;United Kingdom
9EUCTR2018-004476-35-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 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
10NCT04252209
(ClinicalTrials.gov)
March 202026/1/2020the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomiathe Effect of Mixture of Natural Products As Salivary Substitute In Comparison To Carboxy Methyl Cellulose In Treatment Of Xerostomia In Patients With Sjogren's Syndrome: Cross Over Randomized Clinical TrialSjogren's Syndrome;XerostomiaOther: natural herbs of coconut, aloe vera, and pepperint;Other: carboxy methyl celluloseCairo UniversityNULLNot yet recruiting18 Years80 YearsAll44Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004476-35-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 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
12NCT04186871
(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 SquibbNULLRecruiting18 Years65 YearsAll185Phase 2United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
13EUCTR2018-004476-35-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
14EUCTR2018-004476-35-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;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
15NCT03905525
(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 PharmaceuticalsNULLRecruiting18 YearsN/AAll260Phase 2United States;Australia;Austria;Brazil;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovenia;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-004476-35-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
17EUCTR2018-004476-35-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
18EUCTR2018-004476-35-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 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
19EUCTR2018-004476-35-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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: 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
20EUCTR2018-004476-35-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 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-004476-35-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 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
22NCT03700138
(ClinicalTrials.gov)
June 24, 201924/8/2018Intravenous 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 NeuropathiesPrimary Sjögren's Syndrome Painful Sensory NeuropathiesDrug: Privigen® 100mg/ml at the dose of 2g/kg of body weight;Drug: NaCl 0,9%University Hospital, Strasbourg, FranceNULLRecruiting18 Years80 YearsAll24Phase 3France
23EUCTR2017-001371-24-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]Hôpitaux Universitaires de StrasbourgNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24Phase 3France
24NCT03817424
(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
25EUCTR2016-003558-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03434106
(ClinicalTrials.gov)
February 10, 20189/2/2018Sjögren's Syndrome Is Associated With Meibomian Gland DysfunctionSjögren's Syndrome Is Associated With Meibomian Gland DysfunctionMeibomian Gland Dysfunction;Sjögren's SyndromeDrug: liposic;Drug: Tears Naturale ForteLanZhou UniversityNULLUnknown status45 Years60 YearsFemale60N/AChina
27NCT03840538
(ClinicalTrials.gov)
January 1, 201812/2/2019Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's SyndromeProbiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's SyndromeSjogren's SyndromeDrug: Probiotic Product - CapCairo UniversityNULLCompleted30 Years70 YearsAll32Phase 1;Phase 2Egypt
28EUCTR2016-003292-22-PL
(EUCTR)
28/09/201723/08/2017 Study 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: 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
29EUCTR2016-003292-22-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
30EUCTR2016-003292-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-003558-34-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
32NCT03226444
(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
33EUCTR2016-003292-22-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
34EUCTR2016-003292-22-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
35EUCTR2016-003292-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2016-003292-22-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]
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
37EUCTR2016-003292-22-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 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
38EUCTR2016-003292-22-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
39EUCTR2016-003558-34-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]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2France;United States;Poland;Spain;Italy;United Kingdom
40NCT03100942
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03060005
(ClinicalTrials.gov)
May 1, 201723/1/2017Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?Sjögren's Syndrome;Meibomian Gland DysfunctionDrug: Tears Naturale Forte;Drug: liposicTung Wah HospitalNULLRecruiting50 Years60 YearsFemale80N/AChina
42EUCTR2016-003292-22-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
43NCT03608761
(ClinicalTrials.gov)
February 6, 20179/7/2018Comparison Between Rebamipide 2% Versus Autologous SerumComparison Between Rebamipide 2% Versus Autologous Serum in the Treatement of the Moderate to Severe Dry Eye Associate With Sjögren Syndrome. Pilot, Crossed, Controled, Randomized And Open StudyDry Eye Syndromes;Sjögren SyndromeDrug: Rebamipide;Biological: autologous serum;Other: autologous serum and rebamipide 2%Hospital Nacional Profesor Alejandro PosadasNULLCompleted18 YearsN/AFemale21Phase 4Argentina
44EUCTR2016-001948-19-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
45EUCTR2016-001948-19-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]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT02915159
(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
47EUCTR2016-001948-19-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
48EUCTR2014-004616-12-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
49EUCTR2014-004616-12-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
50EUCTR2015-004476-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2015-004476-30-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
52NCT02701985
(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
53EUCTR2015-004476-30-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
54EUCTR2015-004476-30-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;United Kingdom
55EUCTR2015-004476-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02775916
(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
57EUCTR2014-004616-12-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
58NCT03411850
(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 SquibbRecruiting18 Years65 YearsAll20Phase 2United States
59EUCTR2013-004808-19-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
60NCT02614716
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02495129
(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
62ChiCTR-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
63NCT02370550
(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
64NCT02291029
(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
65NCT02067910
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2013-004808-19-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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
66Phase 2United States;Hungary;Germany;Switzerland;United Kingdom
67EUCTR2013-004808-19-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
68EUCTR2014-000417-31-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
69NCT02149420
(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
70EUCTR2013-000250-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02027298
(ClinicalTrials.gov)
November 201318/11/2013Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyAbatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyPrimary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid ArthritisDrug: AbataceptThe Cleveland ClinicBristol-Myers SquibbWithdrawn18 YearsN/AAll0Phase 2United States
72NCT02147509
(ClinicalTrials.gov)
March 201313/5/2014Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's SyndromeEvaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's SyndromeSjögren's Syndrome Patients With Severe Dry EyeDrug: 0.02% Fm, SH;Drug: 0.02% Fm, SH, 0.05% CsA;Other: 0.02% Fm, SH, tBCL;Drug: 0.02% Fm, SH, ASJinyang LiNULLCompleted18 Years70 YearsBoth64N/AChina
73JPRN-UMIN000008427
2012/07/1313/07/2012Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome. Patients with dry eye associated with Sjogren's syndrome.Mucosta ophthalmic suspension UD2%Kanazawa Medical UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
74NCT01552681
(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
75EUCTR2011-006196-19-DK
(EUCTR)
28/02/201230/01/2012Clinical Trials with lozenge as local anaesthesia as treatment for oral pain of patients with burning mouth syndrome and Sjögrens syndromClinical Trials with lozenge as local anaesthesia as treatment of oral pain in burning mouth syndrome and Sjögrens syndrome - SB Lozenge Oral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Product Name: Bupizenge
Product Code: BUPI5
INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE
Clinical Research Centre, Hvidovre University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01357447
(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
77NCT01160666
(ClinicalTrials.gov)
March 20109/7/2010Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's SyndromeA Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's SyndromeSjögren's SyndromeDrug: BelimumabAssistance Publique - Hôpitaux de ParisHuman Genome Sciences Inc.Completed18 YearsN/ABoth20Phase 2France
78EUCTR2009-015978-35-FR
(EUCTR)
30/11/200901/10/2009Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISSEtude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISS Syndrome Sjogren's
MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's
Product Name: HGS1006, LymphoStat-B
INN or Proposed INN: belimumab
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2France
79NCT00852839
(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
80NCT00632866
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2007-001708-19-GB
(EUCTR)
21/02/200801/08/2007A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye
TRB CHEMEDICA INTERNATIONAL SANULLNot Recruiting Female: yes
Male: yes
300Phase 3France;United Kingdom
82NCT00631358
(ClinicalTrials.gov)
February 200829/2/2008Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid InterventionSjogren's SyndromeDrug: Maxidex;Other: No treatmentAlcon ResearchNULLCompleted17 YearsN/AAll97Phase 4Canada
83NCT00637793
(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
84EUCTR2007-001708-19-FR
(EUCTR)
23/08/200706/08/2007A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye
Product Name: SVS20
Product Code: SVS20
INN or Proposed INN: sodium hyaluronate
Trade Name: Lacryvisc
INN or Proposed INN: carbomer 974P
Product Name: SALINE
INN or Proposed INN: sodium chloride
TRB CHEMEDICA INTERNATIONAL SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United Kingdom;France
85NCT00391924
(ClinicalTrials.gov)
May 200024/10/2006Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's SyndromeFatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone AdministrationLupus Erythematosus, Systemic;Sjogren's SyndromeDrug: DehydroepiandrosteroneUMC UtrechtUniversity Medical Centre Groningen;Dutch Arthritis AssociationCompleted18 YearsN/AFemale120Phase 2Netherlands