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NCT07137598PHASE2Recruiting

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)

Hoffmann-La Roche

Start Date

12/5/2025

Completion Date

10/8/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count) * Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA * Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) Exclusion Criteria: * Have failed more than two TNF inhibitors or JAK inhibitors * Class IV RA according to ACR revised response criteria (Hochberg et al. 1992) * Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab * Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment. * History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA * Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug * History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class * Any major surgery within 6 weeks prior to screening or a major surgery planned during the study * Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition * History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured * Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections * History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection * History of organ transplant * Any identified confirmed congenital or acquired immunodeficiency * Abnormal laboratory values and liver function test

Interventions

DRUG

Afimkibart

DRUG

Placebo

Interested in This Trial?

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Conditions

Rheumatoid Arthritis

Locations

SunValley Arthritis Center Ltd.

Peoria, Arizona 85381

United States

University of California Medical Center

La Jolla, California 92037

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California 91786

United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida 33321

United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois 60527

United States

Accurate Clinical Research Inc.

Lake Charles, Louisiana 70605

United States

Ohio State University Wexner Medical Center

Columbus, Ohio 43203

United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania 16635

United States

Accurate Clinical Management

Houston, Texas 77089

United States

DM Clinical Research

Tomball, Texas 77375

United States

Tidewater Clinical Research

Chesapeake, Virginia 23320

United States

Rheumatic Disease Center

Glendale, Wisconsin 53217

United States

Centro Medico Arsema

Ciudad Autnoma de Buenos Aires, Buenos Aires C1427

Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Buenos Aires 7600

Argentina

APRILLUS Asistencia e Investigacion

Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA

Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Centro Privado de Medicina Familiar - Mind Out Research

Ciudad Autonoma Buenos Aires, C1417EYH

Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, J5402DIL

Argentina

HUB Erasme

Brussels, 1070

Belgium

UZ Leuven

Leuven, 3000

Belgium

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District 70200-730

Brazil

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

Cuiab, Mato Grosso 78020-500

Brazil

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais 36010-570

Brazil

Centro de Estudos em Terapias Inovadoras ? CETI

Curitiba, Paraná 80030-110

Brazil

Hospital So Lucas da PUCRS

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Hospital das Clínicas FMRP-USP

Ribeirão Preto, São Paulo 14048-900

Brazil

CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos

So Paulo, São Paulo 04266-010

Brazil

Bispebjerg og Frederiksberg Hospital

Frederiksberg, 2000

Denmark

Sjllands Universitetshospital

Kge, 4600

Denmark

CHU Strasbourg Hpital Hautepierre

Strasbourg, Bas Rhin 67091

France

Hopital de la Conception

Marseille, Bouches-du-Rhne 13005

France

Hopital Lapeyronie

Montpellier, Herault 34295

France

Hopital Purpan

Toulouse, Lot Et Garonne 31059

France

Hpital Cochin

Paris, 75014

France

Rheumazentrum Ruhrgebiet

Herne, North Rhine-Westphalia 44649

Germany

Städtisches Klinik Dresden-Friedrichstadt

Dresden, Saxony 01067

Germany

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

Reggio Emilia, Emilia-Romagna 42123

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio 00168

Italy

Istituto Clinico Humanitas

Rozzano, Lombardy 20089

Italy

Nzoz Bif-Med

Bytom, 41-902

Poland

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

Elbl?g, 82-300

Poland

Malopolskie Badania Kliniczne

Krakow, 30-002

Poland

Zespol Poradni Specjalistycznych REUMED

Lublin, 20-607

Poland

Twoja Przychodnia NCM

Nowa Sól, 67-100

Poland

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

Warsaw, 02-637

Poland

Centrum Medyczne Reuma Park

Warsaw, 02-665

Poland

Reumatop Spolka Jawna

Wroclaw, 52-210

Poland

Complejo Hospitalario Universitario A Coruña

La Corua, LA Coruna 15006

Spain

Hospital Regional Universitario de Malaga

Málaga, 29009

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Quironsalud Infanta Luisa

Seville, 41010

Spain

Leicester Royal Infirmary

Leicester, Leicestershire LE1 5WW

United Kingdom

Doncaster Royal Infirmary

Doncaster, South Yorkshire DN2 5LT

United Kingdom

North Tyneside General Hospital

Newcastle upon Tyne, Tyne & Wear NE29 8NH

United Kingdom

Barnet Hospital

Barnet, EN5 3DJ

United Kingdom