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

Launched by ELI LILLY AND COMPANY · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is examining a new medication called LY3871801 to see how well it works and how safe it is for adults with rheumatoid arthritis (RA). Rheumatoid arthritis is a condition that causes inflammation in the joints, leading to pain and swelling. The study is looking for adults aged 18 and older who have been diagnosed with RA for at least three months and have moderate to severe symptoms, meaning they have a certain number of swollen and tender joints. Participants should have previously tried at least one conventional treatment for RA that did not work well for them.

If you join this study, you can expect to receive either the new medication or a comparison treatment, with regular check-ups to monitor your health and any side effects. The trial is currently recruiting participants, and it’s important to know that certain health conditions may prevent eligibility, such as severe heart or kidney issues, or other serious inflammatory diseases. This trial could be an opportunity to contribute to research that may help improve treatment for rheumatoid arthritis in the future.

Gender

ALL

Eligibility 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