Recruiting
Phase 2

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07620392

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Study Details

Brief summary:

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.

Conditions

Rheumatoid Arthritis

Study ID

NCT07620392

Start date

Jun 3, 2026

Status verified date

Aug, 2026

Completion date

Jul 8, 2033

Anticipated

Primary completion date

Jul 8, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart Group I

Participants will recieve Afimkibart as subcutaneous (SC) injection.

experimental: Afimkibart Group II

Participants will receive Afimkibart as SC injection.

Interventions

Afimkibart

Participants will receive Afimkibart as per the schedule mentioned in the protocol.

Primary outcome measure

  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: From Baseline up to 6 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

West Broward Rheumatology Associates, Inc.

Recruiting

Tamarac, Florida, United States, 33321

Accurate Clinical Research Inc.

Recruiting

Lake Charles, Louisiana, United States, 70605

Accurate Clinical Management LLC

Recruiting

Houston, Texas, United States, 77089

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-21.