Clinical trial of tulisokibart in adults with active r-axSpA
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
IRAS ID
1011785
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Researchers want to know if at least one of the trial doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. About 315 people with r-axSpA aged 18 to 80 will take part in this trial for up to about 3 years.
This trial has 3 parts.
Part 1: Treatment will be for 4 months. Participants will be assigned by chance to 1 of 4 groups.
•Group A: 90 participants- tulisokibart (high dose)
•Group B: 90 participants- tulisokibart (medium dose) and placebo
•Group C: 45 participants- tulisokibart (low dose) and placebo
•Group D: 90 participants- placebo
Everyone will receive an injection every 2 weeks. Groups B and C will receive placebo when they do not receive tulisokibart. Neither the researchers nor the participants in the trial know which treatment a participant is receiving (double-blind).
Part 2: Treatment will be for about 10 months. Participants in Groups A and B will continue their assigned treatment from Part 1. Participants in Groups C and D will have an equal chance to receive either:
•High dose of tulisokibart
•Medium dose of tulisokibart and placebo
Part 2 will be double-blind until everyone finishes Part 1. Once the last person to enter the trial completes Part 1, the researchers and the participants in the trial will find out which dose of the trial medicine a participant is receiving (open-label). Participants will also stop receiving placebo.
Part 3 (Optional): Participants can choose to stay in the trial and continue their assigned treatment from Part 2. Treatment will be for about 1 year and 7 months.
During the trial, participants will give blood and urine samples. They will have physical exams, imaging tests, tests to check for lung infections, and answer questions about how they are feeling.REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0521
Date of REC Opinion
12 Sep 2025
REC opinion
Further Information Favourable Opinion