NCT07137598

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)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Afimkibart	Afimkibart will be administered as SC injection.
DRUG	Placebo	Placebo will be administered as SC injection.

Timeline

• Start date: 2025-12-05
• Primary completion: 2027-04-17
• Completion: 2027-10-02
• First posted: 2025-08-22
• Last updated: 2026-04-03

Locations

32 sites across 9 countries: United States, Belgium, Brazil, Denmark, France, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study