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Rheumatoid ArthritisPhase 2NCT07137598

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 2 study testing Afimkibart in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 65 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Afimkibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
65 sitesin 12 countries
Study dates
5 Dec 2025to 2 Oct 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

65 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global.rochegenentechtrials@roche.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

65 sites in 12 countries

United States18 sites, 18 recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Avondale, Arizona, 85392

    Recruiting

  • Tidewater Clinical Research

    Chesapeake, Virginia, 23320

    Recruiting

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

    Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43203

    Recruiting

  • Henry Ford Medical Center- New Center One

    Detroit, Michigan, 48202

    Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

    Recruiting

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

    Recruiting

  • Accurate Clinical Management

    Houston, Texas, 77089

    Recruiting

  • University of California Medical Center

    La Jolla, California, 92037

    Recruiting

  • Accurate Clinical Research Inc.

    Lake Charles, Louisiana, 70605

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Equity Medical

    Owensboro, Kentucky, 42303

    Recruiting

  • SunValley Arthritis Center Ltd.

    Peoria, Arizona, 85381

    Recruiting

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida, 33321

    Recruiting

  • Equity Medical

    The Bronx, New York, 10455

    Recruiting

  • DM Clinical Research at Tomball

    Tomball, Texas, 77375

    Recruiting

  • Inland Rheumatology Clinical Trials Incorporated

    Upland, California, 91786

    Recruiting

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

    Recruiting

Other trials in United States

Poland8 sites, 8 recruiting

  • Nzoz Bif-Med

    Bytom, 41-902

    Recruiting

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

    Elbl?g, 82-300

    Recruiting

  • Malopolskie Badania Kliniczne

    Krakow, 30-002

    Recruiting

  • Zespol Poradni Specjalistycznych REUMED

    Lublin, 20-607

    Recruiting

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100

    Recruiting

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

    Warsaw, 02-637

    Recruiting

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

    Recruiting

  • Reumatop Spolka Jawna

    Wroclaw, 52-210

    Recruiting

Other trials in Poland

Brazil7 sites, 7 recruiting

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

    Recruiting

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Cuiab, Mato Grosso, 78020-500

    Recruiting

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba, Paraná, 80030-110

    Recruiting

  • Centro Mineiro de Pesquisa - CMIP

    Juiz de Fora, Minas Gerais, 36010-570

    Recruiting

  • Hospital So Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

    Recruiting

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto, São Paulo, 14048-900

    Recruiting

  • CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos

    So Paulo, São Paulo, 04266-010

    Recruiting

Other trials in Brazil

Argentina6 sites, 6 recruiting

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA

    Recruiting

  • Centro Medico Arsema

    Ciudad Autnoma de Buenos Aires, Buenos Aires, C1427

    Recruiting

  • Centro Privado de Medicina Familiar - Mind Out Research

    Ciudad Autonoma Buenos Aires, C1417EYH

    Recruiting

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

    San Juan, J5402DIL

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

Other trials in Argentina

France5 sites, 5 recruiting

  • Hopital de la Conception

    Marseille, Bouches-du-Rhne, 13005

    Recruiting

  • Hopital Lapeyronie

    Montpellier, Herault, 34295

    Recruiting

  • Hpital Cochin

    Paris, 75014

    Recruiting

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, Bas Rhin, 67091

    Recruiting

  • Hopital Purpan

    Toulouse, Lot Et Garonne, 31059

    Recruiting

Other trials in France

Spain5 sites, 5 recruiting

  • Complejo Hospitalario Universitario A Coruña

    La Corua, LA Coruna, 15006

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29009

    Recruiting

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Recruiting

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

    Recruiting

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • Barnet Hospital

    Barnet, EN5 3DJ

    Recruiting

  • Doncaster Royal Infirmary

    Doncaster, South Yorkshire, DN2 5LT

    Recruiting

  • Leicester Royal Infirmary

    Leicester, Leicestershire, LE1 5WW

    Recruiting

  • North Tyneside General Hospital

    Newcastle upon Tyne, Tyne & Wear, NE29 8NH

    Recruiting

Other trials in United Kingdom

Italy3 sites, 3 recruiting

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, Emilia-Romagna, 42123

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Recruiting

Other trials in Italy

Mexico3 sites, 3 recruiting

  • Investigacion y Biomedicina de Chihuahua, Sociedad Civil

    Chihuahua City, 31000

    Recruiting

  • Centro de Investigacion de Tratam Innovadores de Sin SC

    Culiacán, Sinaloa, 80000

    Recruiting

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

    Recruiting

Other trials in Mexico

Belgium2 sites, 2 recruiting

  • HUB Erasme

    Brussels, 1070

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Denmark2 sites, 2 recruiting

  • Bispebjerg og Frederiksberg Hospital

    Frederiksberg, 2000

    Recruiting

  • Sjllands Universitetshospital

    Køge, 4600

    Recruiting

Other trials in Denmark

Germany2 sites, 2 recruiting

  • Städtisches Klinik Dresden-Friedrichstadt

    Dresden, Saxony, 01067

    Recruiting

  • Rheumazentrum Ruhrgebiet

    Herne, North Rhine-Westphalia, 44649

    Recruiting

Other trials in Germany

About this study

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

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.

Being tested
Afimkibart, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfimkibartDrug

    Also called PF 06480605, RVT-3101, RO7790121

    Afimkibart will be administered as SC injection.

  • PlaceboDrug

    Placebo will be administered as SC injection.

Study groups in NCT07137598
Study groupRoleWhat they receive
Afimkibart Group IExperimentalParticipants will receive afimkibart via subcutaneous (SC) injection.
Receives: Drug: Afimkibart
Afimkibart Group IIExperimentalParticipants will receive afimkibart via SC injection.
Receives: Drug: Afimkibart
PlaceboPlacebo comparatorParticipants will receive afimkibart matched placebo via SC injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)

    Measured: Baseline, At Week 14

Secondary outcomes (17)

  1. Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)

    Measured: At Week 14

  2. Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score

    Measured: Baseline, At Week 14 and Week 24

  3. Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC)

    Measured: Baseline, At Week 14 and Week 24

  4. Change From Baseline in the ACR Core Set - Tender Joint Count (TJC)

    Measured: Baseline, At Week 14 and Week 24

  5. Change From Baseline in the ACR Core Set - Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)

    Measured: Baseline, At Week 14 and Week 24

  6. Change From Baseline in the ACR Core Set - Patient's Global Assessment of Arthritis Pain-Visual Analog Scale (PGA Arthritis Pain-VAS)

    Measured: Baseline, At Week 14 and Week 24

  7. Change From Baseline in the ACR Core Set - Patient's Global Assessment of Disease Activity-Visual Analog Scale (PaGADA-VAS)

    Measured: Baseline, At Week 14 and Week 24

  8. Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI)

    Measured: Baseline, At Week 14 and Week 24

  9. Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP)

    Measured: Baseline, At Week 14 and Week 24

  10. Change from Baseline in ACR20, ACR50 and ACR70 Response Rate

    Measured: Baseline, At Week 24

  11. Change from Baseline in Simplified Disease Activity Index (SDAI) Score

    Measured: Baseline, At Week 14 and Week 24

  12. Change from Baseline in Clinical Disease Activity Index (CDAI) Score

    Measured: Baseline, At Week 14 and Week 24

  13. Change from Baseline in Short Form-36 Health Survey (SF-36) Score

    Measured: Baseline, At Week 14 and Week 24

  14. Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score

    Measured: Baseline, At Week 24

  15. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to Week 38

  16. Serum Concentration of RO7790121 at Specified Timepoints

    Measured: Up to Week 38

  17. Percentage of Participants With Anti-Drug Antibodies

    Measured: Baseline, Up to Week 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start5 Dec 2025
  3. Primary completion17 Apr 2027 (estimated)
  4. Study completion2 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137598
Sponsor's protocol ID
WA45846
Status last verified
Oct 2026
First submitted
15 Aug 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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