Clinical trials: Primary Sjogren's Syndrome
Dry Eye Disease
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.
- Trial name
- NCT07264517
- Testing
- GRF312 5%
- Where
- 10 sites in United States
- Volunteers
- 103 people
- Sponsor
- Instituto Grifols, S.A.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sjogren's Syndrome
Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome
This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of…
- Trial name
- NCT02631538
- Testing
- Belimumab, Rituximab
- Where
- 36 sites in Argentina, Canada and 8 more
- Volunteers
- 86 people
- Sponsor
- GlaxoSmithKline
Healthy, Sicca Syndrome
A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome
The main objective of the study is to characterize the gene expression in immune and epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's syndrome) and non-pSS participants including healthy…
- Conditions
- Healthy, Sicca Syndrome, Sjögren's Syndrome
- Trial name
- NCT02422407
- Testing
- Biopsy
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biogen
Sjogren's Syndrome
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants…
- Trial name
- NCT02701985
- Testing
- RO5459072
- Where
- 31 sites in United States, France and 4 more
- Volunteers
- 75 people
- Sponsor
- Hoffmann-La Roche
Primary Sjögren's Syndrome
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients.
- Trial name
- NCT06484855
- Testing
- IBI355
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
Sjogren's Syndrome (SS)
An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)
Sjogren's syndrome (SS) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement.
- Trial name
- NCT05217472
- Testing
- Ravaglimab, Ravagalimab
- Where
- Netherlands
- Sponsor
- AbbVie
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.
Primary Sjogren's Syndrome
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.
- Trial name
- NCT05673993
- Testing
- Telitacicept 80 mg, Telitacicept 160 mg
- Where
- 78 sites in China
- Volunteers
- 381 people
- Sponsor
- RemeGen Co., Ltd.
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
Primary Sjögren Syndrome
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)
This is a first exploration of GLPG3970 in participants with active primary Sjogren's Syndrome (pSS) to evaluate the efficacy, safety and tolerability and to determine its pharmacokinetics (PK) profile compared to placebo.
- Trial name
- GLIDER (NCT04700280)
- Testing
- GLPG3970
- Where
- 10 sites in Germany, Greece and 3 more
- Volunteers
- 31 people
- Sponsor
- Lakefront Biotherapeutics NV
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
Sjogren's Disease
ONO-4915 in Patients With Primary Sjogren's Disease
To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease
- Trial name
- NCT07823790
- Testing
- ONO-4915
- Volunteers
- 60 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
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
A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.
- Trial name
- NCT04830644
- Testing
- Iguratimod
- Where
- 30 sites in China
- Volunteers
- 144 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
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
Primary Sjögren's Syndrome
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
- Trial name
- NCT06979531
- Testing
- IMVT-1402
- Where
- 96 sites in United States, Argentina and 11 more
- Volunteers
- 180 people
- Sponsor
- Immunovant Sciences GmbH
Primary Sjogren Syndrome
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters
- Trial name
- NCT02962895
- Testing
- VAY736
- Where
- 56 sites in United States, Argentina and 17 more
- Volunteers
- 190 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