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

NCT07620392 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: WA464402025-523579-47-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  From Baseline up to 6 years

Secondary Outcomes (13)

• Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)

  Up to 6 years

• Change from baseline in Individual Components of ACR

  Baseline, Up to 6 years

• Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP)

  Baseline, Up to 6 years

• Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score

  Up to 6 years

• Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score

  Up to 6 years

Study Arms (2)

Afimkibart Group I

EXPERIMENTAL

Participants will recieve Afimkibart as subcutaneous (SC) injection.

Drug: Afimkibart

Afimkibart Group II

EXPERIMENTAL

Participants will receive Afimkibart as SC injection.

Drug: Afimkibart

Interventions

Afimkibart DRUG

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

Also known as: PF-06480605, RVT-3101, RO7790121

Afimkibart Group I; Afimkibart Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WA46440 https://forpatients.roche.com/

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 5, 2032
• Study Completion (Estimated): June 5, 2032
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share