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

ID#: NCT05848258

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: May 23, 2023

End Date: July 01, 2026

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
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).
Eligibility:

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