Peresolimab for Rheumatoid Arthritis
(RESOLUTION-1 Trial)

Recruiting in Palo Alto (17 mi)

+172 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called peresolimab to see if it is safe and effective for adults with moderate to severe rheumatoid arthritis. The medication aims to reduce inflammation and joint damage by calming the immune system.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with rheumatoid arthritis that's moderately-to-severely active. Participants must have had the condition for at least 3 months and not responded well to previous treatments. They should not have severe RA, poorly controlled diabetes or hypertension, serious heart issues, chronic kidney disease stage IIIb or worse, or other major inflammatory diseases.

Inclusion Criteria

I have active RA with 6 or more swollen and tender joints.

I have not responded well to at least one standard arthritis treatment.

I have been diagnosed with rheumatoid arthritis for at least 3 months.

Exclusion Criteria

My rheumatoid arthritis is severe, limiting my ability to move.

Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to poorly controlled diabetes or hypertension, chronic kidney disease stage IIIb, IV, or V, symptomatic heart failure according to New York Heart Association Class II, III, or IV, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization, severe chronic pulmonary disease requiring oxygen therapy

I have a chronic inflammatory or connective tissue disease other than rheumatoid arthritis.

Treatment Details

Interventions

Peresolimab (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe study tests Peresolimab's safety and effectiveness against a placebo in treating rheumatoid arthritis. It aims to see if Peresolimab can help those who haven't done well on standard treatments.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Peresolimab Dose 3Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group II: Peresolimab Dose 2Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group III: Peresolimab Dose 1Experimental Treatment1 Intervention

Participants will be given peresolimab by subcutaneous injection.

Group IV: PlaceboActive Control1 Intervention

Participants will be give placebo by subcutaneous injection.