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NCT07137598RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
15 Aug 2025
Start date
5 Dec 2025
Primary completion date
17 Apr 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07137598

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From 5 Dec 2025 to the primary completion date, 17 Apr 2027
  • 65 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have failed more than two TNF inhibitors or JAK inhibitors
  • 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
  • Any major surgery within 6 weeks prior to screening or a major surgery planned during the study

Other illness

  • Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
  • 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 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

Lab values

  • Abnormal laboratory values and liver function test

Other

  • Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
  • Any identified confirmed congenital or acquired immunodeficiency

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (65)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aprillus Asistencia e Investigación
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Buenos AiresArgentinaRecruiting
Centro Medico Arsema
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Ciudad Autnoma de Buenos AiresArgentinaRecruiting
Centro Privado de Medicina Familiar - Mind Out Research
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaRecruiting
CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica
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San JuanArgentinaRecruiting
Centro de Investigaciones Medicas Tucuman
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San Miguel de TucumánArgentinaRecruiting
HUB Erasme
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BrusselsBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
L2IP - Instituto de Pesquisas Clínicas Ltda
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BrasíliaBrazilRecruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
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CuiabBrazilRecruiting
Centro de Estudos em Terapias Inovadoras ? CETI
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CuritibaBrazilRecruiting
Centro Mineiro de Pesquisa - CMiP
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Juiz de ForaBrazilRecruiting
Hospital So Lucas da PUCRS
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Porto AlegreBrazilRecruiting
Hospital das Clínicas FMRP-USP
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Ribeirão PretoBrazilRecruiting
CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos
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So PauloBrazilRecruiting
Städtisches Klinik Dresden-Friedrichstadt
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DresdenGermanyRecruiting
Rheumazentrum Ruhrgebiet
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HerneGermanyRecruiting
Bispebjerg og Frederiksberg Hospital
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FrederiksbergDenmarkRecruiting
Sjllands Universitetshospital
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KøgeDenmarkRecruiting
Complejo Hospitalario Universitario A Coruña
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La CoruaSpainRecruiting
Hospital Regional Universitario de Malaga
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MálagaSpainRecruiting
Complejo Hospitalario Universitario de Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Quironsalud Infanta Luisa
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SevilleSpainRecruiting
Hospital Universitario Virgen Macarena
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SevilleSpainRecruiting
Hôpital de la Conception
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MarseilleFranceRecruiting
Hôpital LAPEYRONIE
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MontpellierFranceRecruiting
Hpital Cochin
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ParisFranceRecruiting
CHU Strasbourg Hpital Hautepierre
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StrasbourgFranceRecruiting
Hopital Purpan
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ToulouseFranceRecruiting
Barnet Hospital
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BarnetUnited KingdomRecruiting
Doncaster Royal Infirmary
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DoncasterUnited KingdomRecruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomRecruiting
North Tyneside General Hospital
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Newcastle upon TyneUnited KingdomRecruiting
Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
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Reggio EmiliaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Istituto Clinico Humanitas
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RozzanoItalyRecruiting
Investigacion y Biomedicina de Chihuahua, Sociedad Civil
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Chihuahua CityMexicoRecruiting
Centro de Investigacion de Tratam Innovadores de Sin SC
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CuliacánMexicoRecruiting
Medical Care & Research Sa de Cv
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MéridaMexicoRecruiting
Nzoz Bif-Med
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BytomPolandRecruiting
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
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Elbl?gPolandRecruiting
Malopolskie Badania Kliniczne
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KrakowPolandRecruiting
Zespol Poradni Specjalistycznych REUMED
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LublinPolandRecruiting
Twoja Przychodnia NCM
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Nowa SólPolandRecruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
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WarsawPolandRecruiting
Centrum Medyczne Reuma Park
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WarsawPolandRecruiting
Reumatop Spolka Jawna
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WroclawPolandRecruiting
Arizona Arthritis & Rheumatology Associates, P.C.
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AvondaleUnited StatesRecruiting
Tidewater Clinical Research
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ChesapeakeUnited StatesRecruiting
Precision Comprehensive Clinical Research Solutions
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ColleyvilleUnited StatesRecruiting
Ohio State University Wexner Medical Center
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ColumbusUnited StatesRecruiting
Henry Ford Medical Center - New Center One
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DetroitUnited StatesRecruiting
Altoona Center For Clinical Research
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DuncansvilleUnited StatesRecruiting
Rheumatic Disease Center
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GlendaleUnited StatesRecruiting
Accurate Clinical Management
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HoustonUnited StatesRecruiting
University of California Medical Center
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La JollaUnited StatesRecruiting
Accurate Clinical Research, Inc
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Lake CharlesUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Equity Medical
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OwensboroUnited StatesRecruiting
SunValley Arthritis Center Ltd.
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PeoriaUnited StatesRecruiting
West Broward Rheumatology Associates, Inc.
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TamaracUnited StatesRecruiting
Equity Medical
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The BronxUnited StatesRecruiting
DM Clinical Research at Tomball
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TomballUnited StatesRecruiting
Inland Rheumatology Clinical Trials Incorporated
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UplandUnited StatesRecruiting
Willow Rheumatology and Wellness PLLC
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WillowbrookUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.