Status:
RECRUITING
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Rigel Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT05848258
Start Date
May 23 2023
End Date
July 1 2026
Last Update
December 9 2025
Active Locations (57)
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1
Newport Huntington Medical Group
Huntington Beach, California, United States, 92648
2
Integrity Clinical Research
Doral, Florida, United States, 33122
3
Advanced Clinical Research of Orlando - Ocoee
Ocoee, Florida, United States, 34761
4
Encore Medical Research - Weston
Weston, Florida, United States, 33331