Clinical trials: Sjögren's Disease
Sjogren Syndrome, Mixed Connective Tissue Disease
A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
This study was a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).
- Trial name
- NCT04988087
- Testing
- MHV370
- Where
- 10 sites in China, Germany and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Sjögren's Disease
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection…
- Trial name
- NCT07737743
- Testing
- DDY391
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 344 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
Sjögren's Disease
A Study of IBI355 in Participants With Moderate-to-Severe Sjögren's Disease
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
- Trial name
- NCT07836660
- Testing
- Part B -Telitacicept, Part A - IBI355
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
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.
Dry Eye With Sjögren's Syndrome
A Long-term 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
- NCT02503163
- Testing
- KCT-0809 ophthalmic solution
- Where
- Japan
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
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
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 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
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.
Sjögren's Syndrome
Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
- Trial name
- NCT07192666
- Testing
- Exosome Preparation
- Volunteers
- 12 people
- Sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
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
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.
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Sjögren's Syndrome
MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.
- Trial name
- NCT07185139
- Testing
- MSCohi-O Lenses
- Volunteers
- 12 people
- Sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
Autoimmune Diseases
A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts
This is a pilot imaging study to determine whether molecular imaging with 18^F fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT), 11^C-Methionine (MET) PET/CT, and salivary gland magnetic…
- Trial name
- NCT02899377
- Testing
- 18F-FDG PET/CT Imaging, 11C-MET PET/CT Imaging, MRI Imaging with intravenous contrast with gadoterate meglumine
- Where
- 4 sites in United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline