An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

Recruiting now · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.

Key facts

Study ID

NCT07620392

Run by

Hoffmann-La Roche

People needed

120

Starts

2026-06-03

Expected to finish

2033-07-08

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed the treatment period of the parent study
• Agreement to adhere to the contraception requirements
• Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline

You may not qualify if…

• Withdrawal of consent and/or premature discontinuation from parent study
• Any permanent discontinuation of study drug in parent study
• Use of a prohibited therapy during the parent study
• Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial

Where it is running

• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States (enrolling)
• Accurate Clinical Management LLC — Houston, Texas, United States (enrolling)
• DM Clinical Research — Tomball, Texas, United States (enrolling)
• Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne — Elblag, Poland (enrolling)
• Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda — Lublin, Poland (enrolling)
• Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna — Wroclaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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