A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05516758
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Arthritis
- Autoimmune Diseases
- Connective Tissue Diseases
- Immune System Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Rheumatoid Arthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Peresolimab — DRUGAdministered SC
- Placebo — DRUGAdministered SC
Study Details
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
Key Dates
- First listed
- Aug 26, 2022
- Start date
- Aug 31, 2022
- Status verified
- Nov 2025
- Primary completion
- Nov 20, 2023
- Completion
- Jan 17, 2025
Study Design
- Enrollment
- 491 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Peresolimab 1000 mg SC Q4WParticipants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.
- Experimental: Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12WParticipants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.
- Experimental: Peresolimab 400 mg SC Q4WParticipants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.
- Experimental: Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12WParticipants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.
- Experimental: Peresolimab 100 mg SC Q4WParticipants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.
- Experimental: Placebo SC Q4W to Peresolimab 1000 mg SC Q4WParticipants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.
- Experimental: Placebo SC Q4W to Peresolimab 400 mg SC Q4WParticipants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.
Primary Outcome Measure
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12 [ Time Frame: Week 12 ]
Locations (54)
Find similar trials in Birmingham, AL
Nationwide
By condition
By research site
Accel Research Sites - Birmingham Clinical Research Unit· Birmingham, ALArizona Arthritis & Rheumatology Research PLLC· Gilbert, AZArizona Arthritis & Rheumatology Research, PLLC· Glendale, AZArizona Arthritis & Rheumatology Research, PLLC· Mesa, AZArizona Arthritis & Rheumatology Associates, PLLC· Phoenix, AZMedvin Clinical Research - Metyas· Covina, CA
Related Studies
- A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)Recruiting · Center for International Blood and Marrow Transplant Research · Birmingham, Alabama
- Conjoint Analysis of Patient Preferences in Joint InterventionsEnrolling By Invitation · Duke University · Durham, North Carolina
- Physica System Total Knee Replacement Registry StudyRecruiting · Limacorporate S.p.a · Rancho Mirage, California
- Maternal Autoimmune Disease Research Alliance (MADRA) RegistryRecruiting · Duke University · Durham, North Carolina