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Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjögren’s Syndrome
EU CTIS ID: 2023-503327-26-00
What this study is testing
To compare the efficacy of deucravacitinib versus placebo in participants with active SjS by ESSDAI improvement at Week 52
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eligible participants will include adults (≥ 18 years old or local age of majority) who satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS, have moderate to severe SjS (ESSDAI ≥ 5), and be positive for anti-SSA/Ro antibody. Other eligibility criteria will include short duration of disease (≤ 10 years) and a SWSF ≥ 0.05 mL/minute
You likely can't join if
- Participants with the following diagnoses are excluded: autoimmune disease other than SjS (e.g. rheumatoid arthritis, SLE, systemic sclerosis), active fibromyalgia, medical condition(s) associated with sicca syndrome, severe complications of SjS (vasculitis, lymphoma, active central nervous system or peripheral nervous system involvement, severe renal/pulmonary/muscular involvement). Participants with prior exposure to deucravacitinib or TYK2 inhibitor, prior exposure to biological therapy within washout period or receiving therapy for active or chronic infection are also excluded.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Colombia
- Peru
- United Kingdom
- Turkey
- Canada
- Australia
- Argentina
- Japan
- Chile
- Mexico
- China
- Switzerland
- Taiwan
- Israel
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Colombia; Peru; United Kingdom; Turkey and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.