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
- Diseases
- Rheumatoid arthritis
- 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
Sites (65)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aprillus Asistencia e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro Medico Arsema Coordinator of this site? Confirm its status | Ciudad Autnoma de Buenos Aires | Argentina | Recruiting |
| Centro Privado de Medicina Familiar - Mind Out Research Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Medicas Mar Del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| CER SAN JUAN - Centro Polivalente de Asistencia e Investigación Clínica Coordinator of this site? Confirm its status | San Juan | Argentina | Recruiting |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| HUB Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| L2IP - Instituto de Pesquisas Clínicas Ltda Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| IPC MT Instituto de Pesquisas Clinicas do Mato Grosso Coordinator of this site? Confirm its status | Cuiab | Brazil | Recruiting |
| Centro de Estudos em Terapias Inovadoras ? CETI Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Centro Mineiro de Pesquisa - CMiP Coordinator of this site? Confirm its status | Juiz de Fora | Brazil | Recruiting |
| Hospital So Lucas da PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital das Clínicas FMRP-USP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos Coordinator of this site? Confirm its status | So Paulo | Brazil | Recruiting |
| Städtisches Klinik Dresden-Friedrichstadt Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Rheumazentrum Ruhrgebiet Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Bispebjerg og Frederiksberg Hospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Recruiting |
| Sjllands Universitetshospital Coordinator of this site? Confirm its status | Køge | Denmark | Recruiting |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | La Corua | Spain | Recruiting |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Complejo Hospitalario Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hôpital de la Conception Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hôpital LAPEYRONIE Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Hpital Cochin Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU Strasbourg Hpital Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Barnet Hospital Coordinator of this site? Confirm its status | Barnet | United Kingdom | Recruiting |
| Doncaster Royal Infirmary Coordinator of this site? Confirm its status | Doncaster | United Kingdom | Recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| North Tyneside General Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Investigacion y Biomedicina de Chihuahua, Sociedad Civil Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| Centro de Investigacion de Tratam Innovadores de Sin SC Coordinator of this site? Confirm its status | Culiacán | Mexico | Recruiting |
| Medical Care & Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Nzoz Bif-Med Coordinator of this site? Confirm its status | Bytom | Poland | Recruiting |
| Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne Coordinator of this site? Confirm its status | Elbl?g | Poland | Recruiting |
| Malopolskie Badania Kliniczne Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Zespol Poradni Specjalistycznych REUMED Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Twoja Przychodnia NCM Coordinator of this site? Confirm its status | Nowa Sól | Poland | Recruiting |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centrum Medyczne Reuma Park Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Reumatop Spolka Jawna Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Arizona Arthritis & Rheumatology Associates, P.C. Coordinator of this site? Confirm its status | Avondale | United States | Recruiting |
| Tidewater Clinical Research Coordinator of this site? Confirm its status | Chesapeake | United States | Recruiting |
| Precision Comprehensive Clinical Research Solutions Coordinator of this site? Confirm its status | Colleyville | United States | Recruiting |
| Ohio State University Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Henry Ford Medical Center - New Center One Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Recruiting |
| Rheumatic Disease Center Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Accurate Clinical Management Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California Medical Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Accurate Clinical Research, Inc Coordinator of this site? Confirm its status | Lake Charles | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Equity Medical Coordinator of this site? Confirm its status | Owensboro | United States | Recruiting |
| SunValley Arthritis Center Ltd. Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| West Broward Rheumatology Associates, Inc. Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| Equity Medical Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| DM Clinical Research at Tomball Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| Inland Rheumatology Clinical Trials Incorporated Coordinator of this site? Confirm its status | Upland | United States | Recruiting |
| Willow Rheumatology and Wellness PLLC Coordinator of this site? Confirm its status | Willowbrook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.