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

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

Conditions2

Locations12 sites

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