A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)

Launched by HOFFMANN-LA ROCHE · Aug 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called Afimkibart (RO7790121) to see if it is safe and can help people with moderate to severe rheumatoid arthritis (RA). RA is a condition that causes painful swelling in the joints. This study is for people whose RA has not improved enough or who cannot tolerate certain common RA treatments called TNF inhibitors and JAK inhibitors. The goal is to find out whether Afimkibart works better than a placebo (a harmless, inactive treatment) in reducing joint pain and swelling.

To join this study, participants need to be adults with moderate to severe RA, meaning they have at least 6 swollen and tender joints, and have had RA for at least 3 months. They must have tried at least one standard RA medication without enough success or with side effects that made it hard to continue. People who have tried many other treatments or have certain other health issues won’t be eligible. If selected, participants will receive either Afimkibart or a placebo and will be monitored closely to see how well the treatment works and to check for any side effects. This study has not started recruiting yet but is open to all genders between the ages of 18 and 74.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has moderate to severe active RA defined by the presence of \>= 6 swollen joints and \>= 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)
• Exclusion Criteria:
• • 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.
• • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
• • Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
• • History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
• • Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
• • Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
• • History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
• • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
• • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
• • History of organ transplant
• • Any identified confirmed congenital or acquired immunodeficiency
• • Abnormal laboratory values and liver function test