KPL-404 for Rheumatoid Arthritis
Trial Summary
What is the purpose of this trial?
This trial tests KPL-404, a new medication for moderate to severe Rheumatoid Arthritis. It focuses on patients who haven't responded well to other treatments. The study will evaluate how safe and effective KPL-404 is and how it works in the body.
Will I have to stop taking my current medications?
You will need to stop taking any biological disease-modifying anti-rheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) before starting the trial. The required time without these medications (washout period) varies: 4 weeks for etanercept, 8 weeks for several others, 1 year for rituximab, and 2 weeks for JAKi. However, you can continue taking certain conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) if they are stable.
Eligibility Criteria
Adults with moderate to severe Rheumatoid Arthritis who haven't responded well or are intolerant to at least one biologic DMARD or a JAK inhibitor. They should be on stable csDMARD therapy, have active disease indicated by joint counts and lab tests, and must have completed their COVID-19 vaccination. Excluded are those with recent steroid injections, prior anti-CD40/CD40L treatment, early arthritis onset before age 16, high thromboembolic risk, certain heart conditions, uncontrolled hypertension, significant ECG abnormalities or a history of cancer (except some skin cancers).Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KPL-404 or placebo for 12 weeks with varying dosing schedules
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- KPL-404
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kiniksa Pharmaceuticals, Ltd.
Lead Sponsor