A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)
NCT: NCT07276581 ·
Status: RECRUITING ·
Phase: Phase 2
· Sponsor: AstraZeneca
· Started: 2025-12-15
· Est. Completion: 2028-08-18
Official Summary
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 320 participants
Interventions
- DRUG: AZD1163 — Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
- OTHER: Placebo — Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24.
Primary Outcomes
- Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 (Week 12)
Secondary Outcomes
- Percentage of Participants Achieving American College of Rheumatology Response Criteria 20 (ACR20) at Week 12 (Week 12)
- Percentage of Participants Achieving ACR50 at Week 12 (Week 12)
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 (Week 12)
- Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12 (Week 12)
- Summary statistics to evaluate the PK of AZD1163 (Week 0 to Week 24 and Follow-Up)
Trial Locations
- Research Site, Glendale, Arizona, United States
- Research Site, Prescott Valley, Arizona, United States
- Research Site, Tucson, Arizona, United States
- Research Site, La Jolla, California, United States
- Research Site, San Dimas, California, United States
- Research Site, San Leandro, California, United States
- Research Site, Aurora, Colorado, United States
- Research Site, Avon Park, Florida, United States
- Research Site, Boynton Beach, Florida, United States
- Research Site, Jacksonville, 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.