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Clinical Trials in the USA / NCT07620392
Recruiting Phase 2

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
2026-10-16

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
No
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 (12)

FacilityCityRegionStatus
Arthritis and Rheumatic Disease Specialty Inc Tamarac Florida Recruiting
Accurate Clinical Research Inc. Lake Charles Louisiana Recruiting
Accurate Clinical Management LLC Houston Texas Recruiting
DM Clinical Research at Tomball Tomball Texas Recruiting
Rheumatic Disease Center Glendale Wisconsin Recruiting
Centro Mineiro de Pesquisa - CMIP Juiz de Fora Minas Gerais 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 Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer Recruiting
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma Active, not recruiting
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease Recruiting
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Active, not recruiting

Other trials for the same condition

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee Active, not recruiting
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases Starting soon
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis Recruiting
Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) Enrolling by invitation
Study of GS-0151 in Participants With Rheumatoid Arthritis Active, not recruiting
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