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Clinical Trials in the UK / NCT07137598
Recruiting Phase 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)

NCT07137598 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2025-12-05
Last updated
2026-08-25

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

AfimkibartPlacebo

Afimkibart: Afimkibart will be administered as SC injection.

Placebo: Placebo will be administered as SC injection.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
SunValley Arthritis Center Ltd. Peoria Arizona Recruiting
University of California Medical Center La Jolla California Recruiting
Cedars Sinai Medical Center Los Angeles California Recruiting
Inland Rheumatology Clinical Trials Incorporated Upland California Recruiting
West Broward Rheumatology Associates, Inc. Tamarac Florida Recruiting
Willow Rheumatology and Wellness PLLC Willowbrook Illinois Recruiting
Accurate Clinical Research Inc. Lake Charles Louisiana Recruiting
Henry Ford Medical Center- New Center One Detroit Michigan Recruiting
Equity Medical The Bronx New York Recruiting
Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Altoona Center For Clinical Research Duncansville Pennsylvania Recruiting
Precision Comprehensive Clinical Research Solutions Colleyville Texas Recruiting
Accurate Clinical Management Houston Texas Recruiting
DM Clinical Research Tomball Texas Recruiting
Tidewater Clinical Research Chesapeake Virginia Recruiting
Rheumatic Disease Center Glendale Wisconsin Recruiting
Centro Medico Arsema Ciudad Autnoma de Buenos Aires Buenos Aires Recruiting
Centro de Investigaciones Medicas Mar Del Plata Mar del Plata Buenos Aires Recruiting
APRILLUS Asistencia e Investigacion Buenos Aires Ciudad Autonoma Buenos Aires Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Tucumán Province Recruiting
Centro Privado de Medicina Familiar - Mind Out Research Ciudad Autonoma Buenos Aires Argentina Recruiting
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica San Juan Argentina Recruiting
HUB Erasme Brussels Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda. Brasília Federal District Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso Cuiab Mato Grosso Recruiting
Centro Mineiro de Pesquisa - CMIP Juiz de Fora Minas Gerais Recruiting
Centro de Estudos em Terapias Inovadoras ? CETI Curitiba Paraná Recruiting
Hospital So Lucas da PUCRS Porto Alegre Rio Grande do Sul Recruiting
Hospital das Clínicas FMRP-USP Ribeirão Preto São Paulo Recruiting
CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos So Paulo São Paulo Recruiting
Bispebjerg og Frederiksberg Hospital Frederiksberg Denmark Recruiting
Sjllands Universitetshospital Kge Denmark Recruiting
CHU Strasbourg Hpital Hautepierre Strasbourg Bas Rhin Recruiting
Hopital de la Conception Marseille Bouches-du-Rhne Recruiting
Hopital Lapeyronie Montpellier Herault Recruiting
Hopital Purpan Toulouse Lot Et Garonne Recruiting
Hpital Cochin Paris France Recruiting
Rheumazentrum Ruhrgebiet Herne North Rhine-Westphalia Recruiting
Städtisches Klinik Dresden-Friedrichstadt Dresden Saxony Recruiting

+ 23 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07137598 on ClinicalTrials.gov ↗ ← All trials in the UK