Clinical trials: Sjögren's Disease
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
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
Sjögren's Syndrome
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
- Trial name
- POETYK SjS-1 (NCT05946941)
- Testing
- Deucravacitinib
- Where
- 199 sites in United States, Argentina and 31 more
- Volunteers
- 774 people
- Sponsor
- Bristol-Myers Squibb
Sjögren's Syndrome, Sjogren's Syndrome
Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)
Primary Objective: To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against…
- Trial name
- phaethuSA (NCT04572841)
- Testing
- SAR441344
- Where
- 36 sites in United States, Argentina and 10 more
- Volunteers
- 84 people
- Sponsor
- Sanofi
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.
Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants…
- Trial name
- NCT07751315
- Testing
- Ia:QLS2404 very low dose, Ia:QLS2404 low dose, Ia:QLS2404 middle dose
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Sjögren's Syndrome
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.
- Trial name
- NCT07118241
- Testing
- Recombinant Human Proteoglycan 4, Vehicle Control
- Where
- 7 sites in Australia
- Volunteers
- 80 people
- Sponsor
- Lubris Bio Pty 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 Syndrome
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).
- Trial name
- SS (NCT04129164)
- Testing
- VIB4920
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 183 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus, Sjögren's Disease
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Psoriasis, Psoriatic Arthritis
- Trial name
- NCT07791199
- Testing
- Deucravacitinib
- Volunteers
- 2,300 people
- Sponsor
- Bristol-Myers Squibb
Sjogren's Syndrome With Dry Eye
RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
A 1-day, randomized (1:1) controlled, masked, pre-market study. Subjects with moderate to severe Sjögren's related Dry Eye Disease will be evaluated at 0, 5, 30 \& 90 minutes post dose of either rhPRG4 (Treatment group) or…
- Trial name
- NCT06520202
- Testing
- rhPRG4 (450 µg/mL), Vehicle
- Where
- Australia
- Volunteers
- 8 people
- Sponsor
- Lubris Bio Pty Ltd
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
Sjogrens Disease, Primary Sjögren's Syndrome Painful Sensory Neuropathies
A Study to Assess Efficacy and Safety of Efgartigimod in Adults With Sjogren's Disease-associated Sensorimotor Polyneuropathy or Sensory Polyneuropathy (SERENITY)
This study aims to assess the efficacy and safety of efgartigimod PH20 in adults with Sjogren's Disease (SjD) associated with nerve damage.
- Trial name
- SERENITY (NCT07760818)
- Testing
- efgartigimod PH20 SC
- Volunteers
- 75 people
- Sponsor
- argenx
Primary Sjögren Syndrome, Dry Eye
Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome
The objective of this study is to evaluate the efficacy and safety of two strengths of Lacripep™ ophthalmic solution versus placebo administered three times daily for four weeks in subjects with a diagnosis of Dry Eye associated…
- Trial name
- NCT03226444
- Testing
- 0.005% Lacripep, 0.01% Lacripep
- Where
- 35 sites in United States
- Volunteers
- 204 people
- Sponsor
- TearSolutions, Inc.
Sjogren's Syndrome
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
- Trial name
- NCT06312020
- Testing
- HZN-1116
- Where
- 66 sites in United States, Argentina and 14 more
- Volunteers
- 209 people
- Sponsor
- Amgen
Sjogren's Syndrome
Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)
Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. This autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying…
- Trial name
- NCT03501420
- Testing
- Interview, PSC questionnaire, PRFs
- Where
- United Kingdom
- Volunteers
- 2,223 people
- Sponsor
- GlaxoSmithKline
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.
Healthy Volunteers, Sjögren's Syndrome
A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome
Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth.
- Trial name
- NCT06544642
- Testing
- ASP5502
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
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
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