RecruitingPhase 2NCT07137598

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)

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

Sponsor

Hoffmann-La Roche

Enrollment

160 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication called RO7790121 in people with moderate to severe rheumatoid arthritis (RA) — a condition where the immune system attacks the joints, causing pain, swelling, and stiffness — who have not responded well to TNF blockers or JAK inhibitor drugs. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis for at least 3 months - You have at least 6 swollen and 6 tender joints - You have tried and had an inadequate response to at least one standard RA medication (csDMARD) - You have tried and did not respond to or could not tolerate a TNF inhibitor or JAK inhibitor **You may NOT be eligible if...** - You have failed more than two TNF inhibitors or JAK inhibitors - You have very severe (Class IV) RA - You have active serious infections, certain cancers, or significant organ problems - You are pregnant or breastfeeding - You have previously used certain biologic RA treatments other than TNF inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAfimkibart

Afimkibart will be administered as SC injection.

DRUGPlacebo

Placebo will be administered as SC injection.

Locations(46)

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

Centro Medico Arsema

Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina

APRILLUS Asistencia e Investigacion

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Centro Privado de Medicina Familiar - Mind Out Research

Ciudad Autonoma Buenos Aires, Argentina

HUB Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, Brazil

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

Cuiab, Mato Grosso, Brazil

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras ? CETI

Curitiba, Paraná, Brazil

Hospital So Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clínicas FMRP-USP

Ribeirão Preto, São Paulo, Brazil

CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos

So Paulo, São Paulo, 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

Rheumazentrum Ruhrgebiet

Herne, North Rhine-Westphalia, Germany

Städtisches Klinik Dresden-Friedrichstadt

Dresden, Saxony, Germany

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

North Tyneside General Hospital

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Barnet Hospital

Barnet, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07137598

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