Phase 2b Study to Evaluate Tulisokibart for Rheumatoid Arthritis

• 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 Rheumatoid Arthritis

• IRAS ID

  1012152

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat rheumatoid arthritis (RA). Tulisokibart (also known as MK-7240) is an experimental medicine. The goals of the trial are to test the safety of tulisokibart, and to see how well tulisokibart works compared to placebo on RA symptoms.

  About 182 people with RA taking a medication called methotrexate, aged 18-80, will take part in this trial.

  Participants in this trial will get tulisokibart at different dosing intervals and will continue to take methotrexate. Some participants will get placebo for some trial treatments.

  This trial has 2 parts.

  Part 1: Initial treatment will be for about 13 months. Participants will be assigned by chance to 1 of 4 groups:

  •Group 1: 52 participants - tulisokibart (high dose)

  •Group 2: 52 participants - tulisokibart (medium dose) and placebo

  •Group 3: 26 participants - tulisokibart (low dose) and placebo for the first 12 weeks. They will then switch to tulisokibart at either the highest or medium dose.

  •Group 4: 52 participants – placebo for the first 12 weeks. Then their treatment will switch to tulisokibart at either the highest or medium dose.

  Everyone will receive an injection every 2 weeks (either placebo or tulisokibart depending on dose they are assigned). Neither the researchers nor the participants in the trial know which treatment a participant is receiving until all participants have completed the first 3 months of treatment. Then the researchers and the participants in the trial will find out which dose of the trial medicine a participant is receiving. Participants will also stop receiving placebo.

  Part 2 (Optional): Participants can choose to stay in the trial and continue to receive tulisokibart for about 18 months.

  During the trial, participants will give blood and urine samples. They will have physical exams, may have imaging tests and answer questions about how they are feeling.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  25/LO/0533

• Date of REC Opinion

  21 Oct 2025

• REC opinion

  Further Information Favourable Opinion