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Tulisokibart in Rheumatoid Arthritis
NCT07176390Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2025
- Primary completion
- Sep 2026
- Countries
- 11
- Sponsor
- Merck & Co.
- Modality
- Monoclonal Antibodies
- Drugs
- tulisokibart
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial of tulisokibart in rheumatoid arthritis (RA) (4 arms), sponsored by Merck & Co. Primary endpoint: American College of Rheumatology 20% Response Criteria at 12 weeks. Started Oct 2025; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedDouble-blind
High-dose tulisokibart
High dose tulisokibart + MTX
Medium-dose tulisokibart
Medium dose tulisokibart + MTX
Low-dose tulisokibart
Low dose tulisokibart + MTX, re-randomized at week 12
Placebo
Placebo + MTX, re-randomized at week 12
03
Who it enrols
Participants must have active rheumatoid arthritis, be currently treated with methotrexate, and be either bDMARD naive or have an inadequate response/intolerance to up to 2 classes of bDMARDs.
04
Endpoints
Primary
American College of Rheumatology 20% Response Criteria
Secondary
American College of Rheumatology 50% Response Criteria
American College of Rheumatology 70% Response Criteria
Low Disease Activity based on Disease Activity Score 28 Using C-Reactive Protein
Health Assessment Questionnaire Disability Index
Adverse Events
Discontinuation Due to an Adverse Event
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