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)

NCT ID
NCT07137598
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Hoffmann-La Roche
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 160 participants (Estimated).

What is being studied

  • Drug: Afimkibart
  • Drug: Placebo

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

63 study locations are listed.

Recruiting site status is explicitly provided for 63 locations; 63 are listed as Recruiting.

Countries: Argentina, Belgium, Brazil, Denmark, France, Germany, Italy, Mexico, Poland, Spain, United Kingdom, United States

  • Buenos Aires, Argentina: 2
  • Ciudad Autonoma Buenos Aires, Argentina: 1
  • Tucumán Province, Argentina: 1
  • Federal District, Brazil: 1
  • Mato Grosso, Brazil: 1
  • Minas Gerais, Brazil: 1
  • Paraná, Brazil: 1
  • Rio Grande do Sul, Brazil: 1
  • São Paulo, Brazil: 2
  • Bas Rhin, France: 1
  • Bouches-du-Rhne, France: 1
  • Herault, France: 1
  • Lot Et Garonne, France: 1
  • North Rhine-Westphalia, Germany: 1
  • Saxony, Germany: 1
  • Emilia-Romagna, Italy: 1
  • Lazio, Italy: 1
  • Lombardy, Italy: 1
  • Sinaloa, Mexico: 1
  • Yucatán, Mexico: 1
  • LA Coruna, Spain: 2
  • Leicestershire, United Kingdom: 1
  • South Yorkshire, United Kingdom: 1
  • Tyne & Wear, United Kingdom: 1
  • Arizona, United States: 1
  • California, United States: 3
  • Florida, United States: 1
  • Illinois, United States: 1
  • Louisiana, United States: 1
  • Michigan, United States: 1

Sample of listed locations

  • Centro Medico Arsema — Ciudad Autnoma de Buenos Aires, Buenos Aires, C1427, Argentina — Recruiting
  • Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Buenos Aires, 7600, Argentina — Recruiting
  • APRILLUS Asistencia e Investigacion — Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina — Recruiting
  • Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Tucumán Province, 4000, Argentina — Recruiting
  • Centro Privado de Medicina Familiar - Mind Out Research — Ciudad Autonoma Buenos Aires, C1417EYH, Argentina — Recruiting
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, J5402DIL, Argentina — Recruiting
  • HUB Erasme — Brussels, 1070, Belgium — Recruiting
  • UZ Leuven — Leuven, 3000, Belgium — Recruiting
  • L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília, Federal District, 70200-730, Brazil — Recruiting
  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Cuiab, Mato Grosso, 78020-500, Brazil — Recruiting
  • Centro Mineiro de Pesquisa - CMIP — Juiz de Fora, Minas Gerais, 36010-570, Brazil — Recruiting
  • Centro de Estudos em Terapias Inovadoras ? CETI — Curitiba, Paraná, 80030-110, Brazil — Recruiting
  • Hospital So Lucas da PUCRS — Porto Alegre, Rio Grande do Sul, 90610-000, Brazil — Recruiting
  • Hospital das Clínicas FMRP-USP — Ribeirão Preto, São Paulo, 14048-900, Brazil — Recruiting
  • CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos — So Paulo, São Paulo, 04266-010, Brazil — Recruiting
  • Bispebjerg og Frederiksberg Hospital — Frederiksberg, 2000, Denmark — Recruiting
  • Sjllands Universitetshospital — Kge, 4600, Denmark — Recruiting
  • CHU Strasbourg Hpital Hautepierre — Strasbourg, Bas Rhin, 67091, France — Recruiting
  • Hopital de la Conception — Marseille, Bouches-du-Rhne, 13005, France — Recruiting
  • Hopital Lapeyronie — Montpellier, Herault, 34295, France — Recruiting
  • Hopital Purpan — Toulouse, Lot Et Garonne, 31059, France — Recruiting
  • Hpital Cochin — Paris, 75014, France — Recruiting
  • Rheumazentrum Ruhrgebiet — Herne, North Rhine-Westphalia, 44649, Germany — Recruiting
  • Städtisches Klinik Dresden-Friedrichstadt — Dresden, Saxony, 01067, Germany — Recruiting
  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia — Reggio Emilia, Emilia-Romagna, 42123, Italy — Recruiting

Study details

Start date
December 5, 2025
Primary completion date
April 17, 2027
Completion date
October 2, 2027
First posted
August 22, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07137598
Registry last updated
September 21, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07137598 on ClinicalTrials.gov

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