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
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.
Arms & interventions
- DrugAfimkibart
Afimkibart will be administered as SC injection.
- DrugPlacebo
Placebo will be administered as SC injection.
Outcome measures
Primary
Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
Time frame: Baseline, At Week 14
Secondary
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Time frame: At Week 14
Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Tender Joint Count (TJC)
Time frame: 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)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Patient's Global Assessment of Arthritis Pain-Visual Analog Scale (PGA Arthritis Pain-VAS)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Patient's Global Assessment of Disease Activity-Visual Analog Scale (PaGADA-VAS)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time frame: Baseline, At Week 14 and Week 24
Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in ACR20, ACR50 and ACR70 Response Rate
Time frame: Baseline, At Week 24
Change from Baseline in Simplified Disease Activity Index (SDAI) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in Clinical Disease Activity Index (CDAI) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline in Short Form-36 Health Survey (SF-36) Score
Time frame: Baseline, At Week 14 and Week 24
Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score
Time frame: Baseline, At Week 24
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to Week 38
Serum Concentration of RO7790121 at Specified Timepoints
Time frame: Up to Week 38
Percentage of Participants With Anti-Drug Antibodies
Time frame: Baseline, Up to Week 38
Eligibility criteria
Study locations (12)
SunValley Arthritis Center Ltd.
Peoria, Arizona, 85381
Cedars Sinai Medical Center
Los Angeles, California, 90048
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, 60527
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605
Ohio State University Wexner Medical Center
Columbus, Ohio, 43203
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Accurate Clinical Management
Houston, Texas, 77089
DM Clinical Research
Tomball, Texas, 77375
Tidewater Clinical Research
Chesapeake, Virginia, 23320
Rheumatic Disease Center
Glendale, Wisconsin, 53217