A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
Official Summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 180 participants
Interventions
- DRUG: Lutikizumab — Subcutaneous (SC) injection
- DRUG: Placebo — Subcutaneous (SC) injection
- DRUG: Ravagalimab — Subcutaneous (SC) injection
Primary Outcomes
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response (At Week 12)
- Number of Participants with Adverse Events (AEs) (Up to Approximately Week 22)
Secondary Outcomes
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response (At Week 12)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response (At Week 12)
- Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) (At Week 12)
- Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP) (At Week 12)
- Change from Baseline in DAS28 (CRP) (At Week 12)
Trial Locations
- Sun Valley Arthritis Center /ID# 278331, Peoria, Arizona, United States
- Private Practice - Dr. David S. Hallegua /ID# 277608, Beverly Hills, California, United States
- Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826, Chula Vista, California, United States
- Newport Huntington Medical Group /ID# 272439, Huntington Beach, California, United States
- Cohen Medical Centers /ID# 278341, Thousand Oaks, California, United States
- The Lundquist Institute /ID# 272481, Torrance, California, United States
- Inland Rheumatology & Osteoporosis Medical Group /ID# 272449, Upland, California, United States
- Tekton Research - Fort Collins - East Harmony Road /ID# 272472, Fort Collins, Colorado, United States
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298, Avon Park, Florida, United States
- Clinical Research Of West Florida - Phase I Unit /ID# 272428, Clearwater, Florida, United States
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.