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.
Has moderate to severe active RA defined by the presence of >=6 swollen joints and >=6 tender joints at screening and baseline (based on 66/68-joint count)
Diagnosis of RA for >=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
Demonstrated an inadequate response or loss of response to or intolerance to >=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
Have failed more than two TNF inhibitors or JAK inhibitors
Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
Hoffmann-La Roche
Lead sponsor