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RECRUITING
NCT07137598
PHASE2

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)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.

Official title: A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-12-05

Completion Date

2027-10-02

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Afimkibart

Afimkibart will be administered as SC injection.

DRUG

Placebo

Placebo will be administered as SC injection.

Locations (32)

SunValley Arthritis Center Ltd.

Peoria, Arizona, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

Accurate Clinical Research Inc.

Lake Charles, Louisiana, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Accurate Clinical Management

Houston, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Tidewater Clinical Research

Chesapeake, Virginia, United States

Rheumatic Disease Center

Glendale, Wisconsin, United States

UZ Leuven

Leuven, Belgium

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, Brazil

Bispebjerg og Frederiksberg Hospital

Frederiksberg, Denmark

Sjllands Universitetshospital

Kge, Denmark

CHU Strasbourg Hpital Hautepierre

Strasbourg, Bas Rhin, France

Hopital de la Conception

Marseille, Bouches-du-Rhne, France

Hopital Lapeyronie

Montpellier, Herault, France

Hopital Purpan

Toulouse, Lot Et Garonne, France

Hpital Cochin

Paris, France

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Nzoz Bif-Med

Bytom, Poland

Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne

Elbl?g, Poland

Malopolskie Badania Kliniczne

Krakow, Poland

Zespol Poradni Specjalistycznych REUMED

Lublin, Poland

Twoja Przychodnia NCM

Nowa Sól, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

Warsaw, Poland

Centrum Medyczne Reuma Park

Warsaw, Poland

Reumatop Spolka Jawna

Wroclaw, Poland

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Doncaster Royal Infirmary

Doncaster, South Yorkshire, United Kingdom