LY3871801 for Rheumatoid Arthritis

Recruiting in Palo Alto (17 mi)

+79 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Class IV RA, Diabetes, Hypertension, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for adults with active moderate-to-severe rheumatoid arthritis (RA) who have had RA for at least 3 months and haven't responded well to previous treatments. Participants should have a significant number of swollen and tender joints. Those with severe other diseases or heart, kidney, lung problems, or different inflammatory conditions are excluded.

Inclusion Criteria

I have active rheumatoid arthritis with at least 6 swollen and 6 tender joints.

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

I've had an inadequate response or intolerance to at least one standard rheumatic drug and one advanced therapy.

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 IIIa or 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 do not have chronic inflammatory diseases other than RA.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 2a

Participants receive LY3871801 or placebo administered orally

12 weeks

Treatment Phase 2b

Participants receive different doses of LY3871801 or placebo administered orally

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

LY3871801 (Monoclonal Antibodies)
Placebo ()

Trial OverviewThe study tests the effectiveness and safety of LY3871801 compared to a placebo in treating RA. It's an adaptive Phase 2a/2b trial, meaning it can change based on results as the trial progresses to find the best dose and treatment response.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3871801 Phase 2aExperimental Treatment1 Intervention

Participants will receive LY3871801 administered orally.

Group II: LY3871801 Dose 3 Phase 2bExperimental Treatment1 Intervention

Participants will receive LY3871801 administered orally.

Group III: LY3871801 Dose 2 Phase 2bExperimental Treatment1 Intervention

Participants will receive LY3871801 administered orally.

Group IV: LY3871801 Dose 1 Phase 2bExperimental Treatment1 Intervention

Participants will receive LY3871801 administered orally.