KPL-404 for Rheumatoid Arthritis

Recruiting at 66 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kiniksa Pharmaceuticals, Ltd.

Must be taking: CsDMARDs

Must not be taking: Injectable corticosteroids

Disqualifiers: Cancer, Cardiovascular conditions, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

145 Participants Needed

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

My arthritis shows active disease with specific blood test results.

I completed my COVID-19 vaccination at least 3 weeks ago.

I have been on stable rheumatoid arthritis medication for at least 4 weeks.

Exclusion Criteria

I have a history of serious heart or blood pressure problems.

I have never been treated with anti-CD40/CD40L drugs.

I haven't taken high-dose steroids or injections in the last 8 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive KPL-404 or placebo for 12 weeks with varying dosing schedules

12 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• KPL-404

Trial Overview The trial is testing KPL-404's safety and effectiveness in people with Rheumatoid Arthritis compared to a placebo. It's looking at how the body processes the drug (pharmacokinetics), how it affects the body (pharmacodynamics), and if it improves symptoms.

Participant Groups

Group I: Cohort 4 KPL-404 Experimental Treatment 1 Intervention

KPL-404 SC q4wk for 12 weeks: 600 mg loading dose at baseline followed by 400 mg at weeks 4 and 8.

Group II: Cohort 3 KPL-404 and Placebo Experimental Treatment 2 Interventions

KPL-404 5mg/kg SC q2wk with alternating weekly administrations of KPL-404 or placebo SC for 12 weeks

Group III: Cohort 3 KPL-404 Experimental Treatment 1 Intervention

KPL-404 5mg/kg SC qwk for 12 weeks

Group IV: Cohort 2 KPL-404 Experimental Treatment 1 Intervention

KPL-404 5mg/kg SC q2wk for 12 weeks

Group V: Cohort 1 KPL-404 Experimental Treatment 1 Intervention

KPL-404 2mg/kg Subcutaneous (SC) q2wk for 12 weeks

Group VI: Cohort 2 Placebo Placebo Group 1 Intervention

Placebo for KPL-404 SC q2wk for 12 weeks

Group VII: Cohort 3 Placebo Placebo Group 1 Intervention

Placebo for KPL-404 SC qwk for 12 weeks

Group VIII: Cohort 4 Placebo Placebo Group 1 Intervention

Placebo for KPL-404 SC q4wk for 12 weeks

Group IX: Cohort 1 Placebo Placebo Group 1 Intervention

Placebo for KPL-404 SC q2wk for 12 weeks

Who Is Running the Clinical Trial?

Kiniksa Pharmaceuticals, Ltd.

Lead Sponsor

Trials

9

Recruited

1,400+