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New hope for tough arthritis cases: experimental drug enters Mid-Stage trial

NCT ID NCT07137598

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 6 times

Summary

This study tests an experimental drug called Afimkibart (RO7790121) in 160 people with moderate to severe rheumatoid arthritis who did not get better with or could not tolerate standard treatments like TNF or JAK inhibitors. Participants will receive either the drug or a placebo to see if it reduces joint swelling and pain. The goal is to find a new option for controlling this chronic autoimmune disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    63 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APRILLUS Asistencia e Investigacion

    RECRUITING

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina

  • Accurate Clinical Management

    RECRUITING

    Houston, Texas, 77089, United States

  • Accurate Clinical Research Inc.

    RECRUITING

    Lake Charles, Louisiana, 70605, United States

  • Altoona Center For Clinical Research

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    RECRUITING

    Reggio Emilia, Emilia-Romagna, 42123, Italy

  • Barnet Hospital

    RECRUITING

    Barnet, EN5 3DJ, United Kingdom

  • Bispebjerg og Frederiksberg Hospital

    RECRUITING

    Frederiksberg, 2000, Denmark

  • CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos

    RECRUITING

    So Paulo, São Paulo, 04266-010, Brazil

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    RECRUITING

    San Juan, J5402DIL, Argentina

  • CHU Strasbourg Hpital Hautepierre

    RECRUITING

    Strasbourg, Bas Rhin, 67091, France

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centro Medico Arsema

    RECRUITING

    Ciudad Autnoma de Buenos Aires, Buenos Aires, C1427, Argentina

  • Centro Mineiro de Pesquisa - CMIP

    RECRUITING

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Centro Privado de Medicina Familiar - Mind Out Research

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1417EYH, Argentina

  • Centro de Estudos em Terapias Inovadoras ? CETI

    RECRUITING

    Curitiba, Paraná, 80030-110, Brazil

  • Centro de Investigacion de Tratam Innovadores de Sin SC

    RECRUITING

    Culiacán, Sinaloa, 80000, Mexico

  • Centro de Investigaciones Medicas Mar Del Plata

    RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Centro de Investigaciones Medicas Tucuman

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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

    RECRUITING

    Elbl?g, 82-300, Poland

  • Centrum Medyczne Reuma Park

    RECRUITING

    Warsaw, 02-665, Poland

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    La Corua, LA Coruna, 15006, Spain

  • Complejo Hospitalario Universitario de Santiago.

    RECRUITING

    Santiago de Compostela, LA Coruna, 15706, Spain

  • DM Clinical Research

    RECRUITING

    Tomball, Texas, 77375, United States

  • Doncaster Royal Infirmary

    RECRUITING

    Doncaster, South Yorkshire, DN2 5LT, United Kingdom

  • Equity Medical

    RECRUITING

    The Bronx, New York, 10455, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, 00168, Italy

  • HUB Erasme

    RECRUITING

    Brussels, 1070, Belgium

  • Henry Ford Medical Center- New Center One

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hopital Lapeyronie

    RECRUITING

    Montpellier, Herault, 34295, France

  • Hopital Purpan

    RECRUITING

    Toulouse, Lot Et Garonne, 31059, France

  • Hopital de la Conception

    RECRUITING

    Marseille, Bouches-du-Rhne, 13005, France

  • Hospital Quironsalud Infanta Luisa

    RECRUITING

    Seville, 41010, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29009, Spain

  • Hospital So Lucas da PUCRS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospital das Clínicas FMRP-USP

    RECRUITING

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Hpital Cochin

    RECRUITING

    Paris, 75014, France

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    RECRUITING

    Cuiab, Mato Grosso, 78020-500, Brazil

  • Inland Rheumatology Clinical Trials Incorporated

    RECRUITING

    Upland, California, 91786, United States

  • Investigacion y Biomedicina de Chihuahua, Sociedad Civil

    RECRUITING

    Chihuahua City, 31000, Mexico

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Malopolskie Badania Kliniczne

    RECRUITING

    Krakow, 30-002, Poland

  • Medical Care & Research SA de CV

    RECRUITING

    Mérida, Yucatán, 97070, Mexico

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

    RECRUITING

    Warsaw, 02-637, Poland

  • North Tyneside General Hospital

    RECRUITING

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

  • Nzoz Bif-Med

    RECRUITING

    Bytom, 41-902, Poland

  • Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43203, United States

  • Precision Comprehensive Clinical Research Solutions

    RECRUITING

    Colleyville, Texas, 76034, United States

  • Reumatop Spolka Jawna

    RECRUITING

    Wroclaw, 52-210, Poland

  • Rheumatic Disease Center

    RECRUITING

    Glendale, Wisconsin, 53217, United States

  • Rheumazentrum Ruhrgebiet

    RECRUITING

    Herne, North Rhine-Westphalia, 44649, Germany

  • Sjllands Universitetshospital

    RECRUITING

    Kge, 4600, Denmark

  • Städtisches Klinik Dresden-Friedrichstadt

    RECRUITING

    Dresden, Saxony, 01067, Germany

  • SunValley Arthritis Center Ltd.

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Tidewater Clinical Research

    RECRUITING

    Chesapeake, Virginia, 23320, United States

  • Twoja Przychodnia NCM

    RECRUITING

    Nowa Sól, 67-100, Poland

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of California Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

  • West Broward Rheumatology Associates, Inc.

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Willow Rheumatology and Wellness PLLC

    RECRUITING

    Willowbrook, Illinois, 60527, United States

  • Zespol Poradni Specjalistycznych REUMED

    RECRUITING

    Lublin, 20-607, Poland

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Other studies related to the condition(s) this trial covers.