A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

Official Summary

This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 160 participants

Interventions

• DRUG: Afimkibart — Afimkibart will be administered as SC injection.
• DRUG: Placebo — Placebo will be administered as SC injection.

Primary Outcomes

• Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) (Baseline, At Week 14)

Secondary Outcomes

• Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) (At Week 14)
• Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score (Baseline, At Week 14 and Week 24)
• Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC) (Baseline, At Week 14 and Week 24)
• Change From Baseline in the ACR Core Set - Tender Joint Count (TJC) (Baseline, At Week 14 and Week 24)
• Change From Baseline in the ACR Core Set - Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) (Baseline, At Week 14 and Week 24)

Trial Locations

• SunValley Arthritis Center Ltd., Peoria, Arizona, United States
• Inland Rheumatology Clinical Trials Incorporated, Upland, California, United States
• West Broward Rheumatology Associates, Inc., Tamarac, Florida, United States
• Willow Rheumatology and Wellness PLLC, Willowbrook, Illinois, United States
• Accurate Clinical Research Inc., Lake Charles, Louisiana, United States
• Ohio State University Wexner Medical Center, Columbus, Ohio, United States
• Altoona Center For Clinical Research, Duncansville, Pennsylvania, United States
• Accurate Clinical Management, Houston, Texas, United States
• DM Clinical Research, Tomball, Texas, United States
• Tidewater Clinical Research, Chesapeake, Virginia, United States
• ...and 10 more locations

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