Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjögren’s Syndrome

Phase 1

Recruiting

• Conditions: Sjogren's syndrome; MedDRA version: 21.0Level: PTClassification code: 10040767Term: Sjogren's syndrome Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-503327-26-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-10
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified