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

NCT07620392 · tracked via the Priya Life Science USA tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 2

Started

2026-06-03

Last updated

2026-09-18

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Afimkibart

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Percentage of Participants With Adverse Events (AEs) — From Baseline up to 6 years

Trial sites (10)

Facility	City	Region	Status
West Broward Rheumatology Associates, Inc.	Tamarac	Florida	Recruiting
Accurate Clinical Research Inc.	Lake Charles	Louisiana	Recruiting
Accurate Clinical Management LLC	Houston	Texas	Recruiting
DM Clinical Research	Tomball	Texas	Recruiting
Centrum Medyczne Reuma Park	Warsaw	Masovian Voivodeship	Recruiting
Nzoz Bif-Med	Bytom	Poland	Recruiting
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne	Elblag	Poland	Recruiting
Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda	Lublin	Poland	Recruiting
Twoja Przychodnia NCM	Nowa Sól	Poland	Recruiting
Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna	Wroclaw	Poland	Recruiting

More Hoffmann-La Roche trials in the USA

A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes Active, not recruiting

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) Active, not recruiting

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease Active, not recruiting

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting

Other trials for the same condition

A Study of AZD0120 in Autoimmune Diseases Recruiting

Insignia™ Hip Stem Outcomes Study Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) Active, not recruiting

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors) Recruiting

Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07620392 on ClinicalTrials.gov ↗ ← All trials in the USA