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

Sponsor
Hoffmann-La Roche
Study ID
NCT07620392
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 5, 2026
Status verified
May 2026
Primary completion
Jun 5, 2032
Completion
Jun 5, 2032

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afimkibart Group I
    Participants will recieve Afimkibart as subcutaneous (SC) injection.
  • Experimental: Afimkibart Group II
    Participants will receive Afimkibart as SC injection.

Primary Outcome Measure

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

Central Contacts

  • Reference Study ID Number: WA46440 https://forpatients.roche.com/
    888-662-6728
    [email protected]

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