RecruitingPhase 2NCT05848258
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Sponsor
Eli Lilly and Company
Enrollment
380 participants
Start Date
May 23, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria18
- 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
Interventions
DRUGLY3871801
Administered orally
DRUGPlacebo
Administered orally
Locations(57)
View Full Details on ClinicalTrials.gov
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NCT05848258
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