An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2026-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Rigel Pharmaceuticals

Criteria

Inclusion Criteria:

• Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.

• Have moderately-to-severely active RA at screening and baseline, defined by the presence of

• ≥6 swollen joints based on 66 joint count, and

• ≥6 tender joints based on 68 joint count.

• Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.

Exclusion Criteria:

• Have Class IV RA according to ACR revised criteria

• 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, for example, requiring oxygen therapy

• major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to

• systemic lupus erythematosus

• psoriatic arthritis

• axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis

• reactive arthritis

• gout

• scleroderma

• polymyositis

• dermatomyositis

• active fibromyalgia, or

• multiple sclerosis