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)

Last updated: May 1, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Joint Injuries

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

Afimkibart

Placebo

Clinical Study ID

NCT07137598
WA45846
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 ofRheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR)classification criteria for RA

  • Demonstrated an inadequate response or loss of response to or intolerance to >=1conventional synthetic disease-modifying antirheumatic drug (csDMARD)

Exclusion

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 theinvestigational therapy, whichever is longer, prior to initiation of studytreatment.

  • History of any arthritis with onset prior to age 17 years or current diagnosis ofinflammatory joint disease other than RA

  • Has been treated with intra-articular, intramuscular, intravenous, trigger point ortender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8weeks prior to the first dose of study drug

  • History of a severe allergic reaction or anaphylactic reaction or knownhypersensitivity to any component of the study drug (or its excipients) and/or otherproducts in the same class

  • Any major surgery within 6 weeks prior to screening or a major surgery plannedduring 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 cutaneoussquamous cell cancer adequately treated with electrodesiccation and curettage orresection or in situ cervical cancer adequately treated and cured

  • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungalinfections

  • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV) infection

  • History of organ transplant

  • Any identified confirmed congenital or acquired immunodeficiency

  • Abnormal laboratory values and liver function test

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Afimkibart
Phase: 2
Study Start date:
December 05, 2025
Estimated Completion Date:
October 02, 2027

Connect with a study center

  • Centro Medico Arsema

    Ciudad Autnoma de Buenos Aires, Buenos Aires C1427
    Argentina

    Active - Recruiting

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA
    Argentina

    Active - Recruiting

  • Centro Privado de Medicina Familiar - Mind Out Research

    Ciudad Autonoma Buenos Aires, C1417EYH
    Argentina

    Active - Recruiting

  • HUB Erasme

    Brussels, 1070
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District 70200-730
    Brazil

    Active - Recruiting

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Cuiab, Mato Grosso 78020-500
    Brazil

    Active - Recruiting

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais 36010-570
    Brazil

    Active - Recruiting

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba, Paraná 80030-110
    Brazil

    Active - Recruiting

  • Hospital So Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul 90610-000
    Brazil

    Active - Recruiting

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto, São Paulo 14048-900
    Brazil

    Active - Recruiting

  • CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos

    So Paulo, São Paulo 04266-010
    Brazil

    Active - Recruiting

  • Bispebjerg og Frederiksberg Hospital

    Frederiksberg, 2000
    Denmark

    Active - Recruiting

  • Bispebjerg og Frederiksberg Hospital

    Frederiksberg 2621942, 2000
    Denmark

    Site Not Available

  • Sjllands Universitetshospital

    Kge, 4600
    Denmark

    Active - Recruiting

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, Bas Rhin 67091
    France

    Active - Recruiting

  • Hopital de la Conception

    Marseille, Bouches-du-Rhne 13005
    France

    Active - Recruiting

  • Hopital Lapeyronie

    Montpellier, Herault 34295
    France

    Active - Recruiting

  • Hopital Purpan

    Toulouse, Lot Et Garonne 31059
    France

    Active - Recruiting

  • Hpital Cochin

    Paris 2988507, Paris 75014
    France

    Site Not Available

  • Hpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Rheumazentrum Ruhrgebiet

    Herne, North Rhine-Westphalia 44649
    Germany

    Active - Recruiting

  • Städtisches Klinik Dresden-Friedrichstadt

    Dresden, Saxony 01067
    Germany

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio 00168
    Italy

    Active - Recruiting

  • Nzoz Bif-Med

    Bytom, 41-902
    Poland

    Active - Recruiting

  • Nzoz Bif-Med

    Bytom 3101950, 41-902
    Poland

    Site Not Available

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

    Elbl?g, 82-300
    Poland

    Active - Recruiting

  • Malopolskie Badania Kliniczne

    Krakow, 30-002
    Poland

    Active - Recruiting

  • Zespol Poradni Specjalistycznych REUMED

    Lublin, 20-607
    Poland

    Active - Recruiting

  • Zespol Poradni Specjalistycznych REUMED

    Lublin 765876, 20-607
    Poland

    Site Not Available

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665
    Poland

    Active - Recruiting

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

    Warsaw, 02-637
    Poland

    Active - Recruiting

  • Reumatop Spolka Jawna

    Wroclaw, 52-210
    Poland

    Active - Recruiting

  • Reumatop Spolka Jawna

    Wroclaw 3081368, 52-210
    Poland

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Málaga, 29009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire DN2 5LT
    United Kingdom

    Active - Recruiting

  • North Tyneside General Hospital

    Newcastle upon Tyne, Tyne & Wear NE29 8NH
    United Kingdom

    Active - Recruiting

  • Barnet Hospital

    Barnet, EN5 3DJ
    United Kingdom

    Active - Recruiting

  • SunValley Arthritis Center Ltd.

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • SunValley Arthritis Center Ltd.

    Peoria 5308480, Arizona 5551752 85381
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials Incorporated

    Upland, California 91786
    United States

    Active - Recruiting

  • Inland Rheumatology Clinical Trials Incorporated

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates, Inc.

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Accurate Clinical Research Inc.

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • Accurate Clinical Research Inc.

    Lake Charles 4330236, Louisiana 4331987 70605
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43203
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Site Not Available

  • Accurate Clinical Management

    Houston, Texas 77089
    United States

    Active - Recruiting

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Accurate Clinical Management

    Houston 4699066, Texas 4736286 77089
    United States

    Site Not Available

  • DM Clinical Research

    Tomball 4737094, Texas 4736286 77375
    United States

    Site Not Available

  • Tidewater Clinical Research

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Active - Recruiting

  • Rheumatic Disease Center

    Glendale 5254404, Wisconsin 5279468 53217
    United States

    Site Not Available

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