An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis (NCT05848258) | Clinical Trial Compass
Active — Not RecruitingPhase 2
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
United States164 participantsStarted 2023-05-23
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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-radiograp…
What they're measuring
1
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Timeframe: Baseline, Week 12
2
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50