Rheumatoid Arthritis
Conditions
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).
Interventions
DRUGLY3871801
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Phase 2a: Percentage of Participants Achieving ACR20/50/70 | Baseline to Week 12 |
| Phase 2b: Change from Baseline in DAS28-hsCRP | Baseline, 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 Clinical Disease Activity Index (CDAI) | 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 in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS) | 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 |
| 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 for SF-36 Mental Component Summary Score | Baseline, Week 12 |
| Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801 | Baseline through Week 20 |
Countries
Argentina, Czechia, France, Germany, Hungary, India, Mexico, Poland, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed