An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
- Registration Number
- NCT05848258
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 380
-
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.
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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.
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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.
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Have Class IV RA according to ACR revised criteria
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Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
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poorly controlled diabetes or hypertension
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chronic kidney disease stage IIIa or IIIb, IV, or V
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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
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Phase 2a Placebo Participants will receive placebo. LY3871801 Phase 2a LY3871801 Participants will receive LY3871801 administered orally. LY3871801 Dose 1 Phase 2b LY3871801 Participants will receive LY3871801 administered orally. LY3871801 Dose 2 Phase 2b LY3871801 Participants will receive LY3871801 administered orally. LY3871801 Dose 3 Phase 2b LY3871801 Participants will receive LY3871801 administered orally. Placebo Phase 2b Placebo Participants will receive placebo.
- Primary Outcome Measures
Name Time Method Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) Baseline, Week 12 Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50 Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Phase 2a: Percentage of Participants Achieving ACR20/50/70 Baseline to Week 12 Phase 2b: Percentage of Participants Achieving ACR20/70 Week 12 Change from Baseline in Simplified Disease Activity Index (SDAI) Baseline, Week 12 Change from Baseline in ACR Core Set Values 68 Tender Joint Counts Baseline, Week 12 Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts Baseline, Week 12 Change from Baseline the Duration and Severity of Morning Joint Stiffness Baseline, Week 12 Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score Baseline, Week 12 Change from Baseline in Clinical Disease Activity Index (CDAI) Baseline, Week 12 Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS Baseline, Week 12 Change from Baseline for Participant's Assessment of Arthritis Pain (VAS) Baseline, Week 12 Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline, Week 12 Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 Baseline through Week 20 Change from Baseline for SF-36 Mental Component Summary Score Baseline, Week 12 Phase 2b: Change from Baseline in DAS28-hsCRP Baseline, Week 12 Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS) Baseline, Week 12
Trial Locations
- Locations (57)
Newport Huntington Medical Group
🇺🇸Huntington Beach, California, United States
Integrity Clinical Research
🇺🇸Doral, Florida, United States
Advanced Clinical Research of Orlando - Ocoee
🇺🇸Ocoee, Florida, United States
Encore Medical Research - Weston
🇺🇸Weston, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Willow Rheumatology and Wellness PLLC
🇺🇸Willowbrook, Illinois, United States
Accurate Clinical Research, Inc
🇺🇸Houston, Texas, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
🇺🇸Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Accellacare - Salisbury
🇺🇸Salisbury, North Carolina, United States
Scroll for more (47 remaining)Newport Huntington Medical Group🇺🇸Huntington Beach, California, United StatesChristine ThaiPrincipal Investigator