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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

2026-05-04

Healthy Volunteers

Conditions

Rheumatoid Arthritis

Interventions

DRUG

Afimkibart

Afimkibart will be administered as SC injection.

DRUG

Placebo

Placebo will be administered as SC injection.

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

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