Clinical trials: Sjögren's Disease
Primary Sjögren's Syndrome
Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome
This study consists of three consecutive parts. Part 1 in primary Sjögren's syndrome (pSS) patients (n=2-6) and Part 2 in healthy voluteers (n=3) are feasibility studies to assess if the selected [Zr-89]-rituximab PET/CT method…
- Trial name
- NCT02495129
- Testing
- VAY736 lower dose, VAY736 higher dose
- Sponsor
- Novartis Pharmaceuticals
Sjogren Disease
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.
- Trial name
- EnVISage (NCT06928142)
- Testing
- Sibeprenlimab
- Where
- 64 sites in United States, Argentina and 6 more
- Volunteers
- 83 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
- Trial name
- NCT07048197
- Testing
- Rapcabtagene autoleucel
- Where
- 12 sites in France, Germany and 2 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Sjögren's Syndrome
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from…
- Trial name
- NCT02843659
- Testing
- BMS-931699, BMS-986142
- Where
- 34 sites in United States, Australia and 9 more
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
Sjogren's Syndrome
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525).
- Trial name
- TWINSS Extn (NCT04541589)
- Testing
- Iscalimab
- Where
- 62 sites in United States, Argentina and 21 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Sjogren Syndrome
Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.
This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments
- Trial name
- NCT05124925
- Testing
- Ianalumab
- Where
- France
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Sjögren's Syndrome
A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)
The main purpose of this study is to learn more about the safety and side effects of the study drug known as LY3090106 in participants with Sjögren's Syndrome (SS).
- Trial name
- NCT02614716
- Testing
- LY3090106
- Where
- 7 sites in United States, Bulgaria and 2 more
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Xerostomia, Sjogren's Syndrome
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.
- Trial name
- NCT00233363
- Testing
- Rebamipide
- Where
- Japan
- Volunteers
- 104 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Sjogren's Syndrome
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1.
- Trial name
- NCT06104124
- Testing
- Dazodalibep
- Where
- 206 sites in United States, Argentina and 24 more
- Volunteers
- 651 people
- Sponsor
- Amgen
Sjögren´s Disease
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
- Trial name
- THALASSA (NCT07621809)
- Testing
- VAY736
- Where
- 33 sites in United States, Australia and 6 more
- Volunteers
- 570 people
- Sponsor
- Novartis Pharmaceuticals
Dry Eye With Sjögren's Syndrome
An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.
- Trial name
- NCT02503176
- Testing
- KCT-0809 ophthalmic solution
- Where
- Japan
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Primary Immune Thrombocytopenia, Sjögren's Syndrome
Managed Access Programs for VAY736, Ianalumab
The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab
- Trial name
- NCT07244289
- Testing
- ianalumab
- Sponsor
- Novartis Pharmaceuticals
Primary Sjogren's Disease
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
- Trial name
- UPSTREAM SjD (NCT07404865)
- Testing
- Telitacicept
- Where
- 49 sites in United States, Georgia
- Volunteers
- 250 people
- Sponsor
- Vor Biopharma
Sjögren Syndrome, Dry Eye
Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Primary Objective To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity. Secondary Objectives To assess corneal sensitivity via Cochet-Bonnet esthesiometer.
- Trial name
- GEMINAE (NCT06411132)
- Testing
- observational study
- Where
- 15 sites in United States
- Volunteers
- 103 people
- Sponsor
- Dompé Farmaceutici S.p.A
Dry Eye Disease, Sjögren Syndrome
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to…
- Trial name
- NCT04819269
- Testing
- Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution
- Where
- 46 sites in United States, Spain
- Volunteers
- 203 people
- Sponsor
- Sylentis, S.A.
Primary Sjögren's Syndrome
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
- Trial name
- NCT02291029
- Testing
- CFZ533 active - Cohort 1, CFZ533 active - Cohort 2, CFZ533 active -Cohort 3
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune Diseases
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)
This study aims to evaluate the safety, tolerability and PK of repeat dose administration of GSK2618960 in the treatment of pSS.
- Trial name
- NCT03239600
- Testing
- GSK2618960 2 mg/kg, Methotrexate
- Where
- United Kingdom
- Sponsor
- GlaxoSmithKline
Dry Eye
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle.
- Trial name
- NCT04391894
- Testing
- ECF843, ECF843 vehicle
- Where
- 52 sites in United States
- Volunteers
- 718 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune Disorder, Rheumatoid Arthritis
Study 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 Arthritis
The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib…
- Conditions
- Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
- Trial name
- NCT04186871
- Testing
- branebrutinib, abatacept
- Where
- 81 sites in United States, Argentina and 8 more
- Volunteers
- 119 people
- Sponsor
- Bristol-Myers Squibb