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

Roche

Status and phase: Not yet enrolling; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Afimkibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07620392

2025-523579-47-00 (EU Trial (CTIS) Number)

WA46440

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Afimkibart Group I

Experimental group

Description:

Participants will recieve Afimkibart as subcutaneous (SC) injection.

Treatment:

Drug: Afimkibart

Afimkibart Group II

Experimental group

Description:

Participants will receive Afimkibart as SC injection.

Treatment:

Drug: Afimkibart