Actively Recruiting
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF andor JAK Inhibitors
Led by Hoffmann-La Roche · Updated on 2026-06-01
160
Participants Needed
51
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Afimkibart RO7790121 to assess its effectiveness and safety compared with a placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded to or cannot tolerate tumor necrosis factor TNF andor Janus kinase JAK inhibitors. This phase II, multicenter, double-blind, placebo-controlled trial is sponsored by Hoffmann-La Roche. The study aims to evaluate changes in disease activity and various health assessments related to RA. Participants will be randomly assigned to receive either Afimkibart or a matching placebo through subcutaneous injections. There are two experimental groups receiving Afimkibart and one placebo group. The study will monitor participants over several weeks, assessing treatment effects at weeks 14 and 24, with safety follow-up up to week 38. During the study, participants will undergo assessments including joint counts, disease activity scores like DAS28-CRP and DAS28-ESR, physical and patient global assessments, health questionnaires, and laboratory tests for inflammation markers. Researchers will also monitor for adverse events and measure drug levels and antibodies. The total participation includes multiple visits over about 38 weeks to carefully evaluate treatment impact and safety.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has moderate to severe active rheumatoid arthritis with at least 6 swollen and 6 tender joints at screening and baseline
- Diagnosed with rheumatoid arthritis for 3 months or longer and meets 2010 ACR/EULAR criteria
- Has had an inadequate response, lost response, or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD)
You will not qualify if you...
- Have failed treatment with more than two TNF inhibitors or JAK inhibitors
- Have Class IV rheumatoid arthritis by ACR criteria
- Past or current use of biologic DMARDs other than TNF inhibitors or rituximab
- Received investigational therapy within 4 weeks or 5 half-lives before study treatment
- History of arthritis starting before age 17 or current inflammatory joint disease other than RA
- Treated with corticosteroids by various routes within 8 weeks before first study dose
- History of severe allergic or anaphylactic reactions to study drug or similar products
- Major surgery within 6 weeks before screening or planned during study
- Serious chronic or unstable medical, psychiatric, or other conditions
- History of malignancy except certain treated skin or cervical cancers
- Severe chronic or recurrent infections
- History of active hepatitis B, hepatitis C, or HIV infection
- History of organ transplant
- Known congenital or acquired immunodeficiency
- Abnormal lab values or liver function tests
Research Team
R
Reference Study ID Number: WA45846 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here