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 | Recruiting Phase 2 FDA Drug

• 1 other identifier: WA45846
• Study Type: interventional
• Target: 160
• Locations: 11 countries
• Sites: 46

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  Baseline, At Week 14

Secondary Outcomes (17)

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

  At Week 14

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

  Baseline, At Week 14 and Week 24

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

  Baseline, At Week 14 and Week 24

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

  Baseline, At Week 14 and Week 24

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

  Baseline, At Week 14 and Week 24

Study Arms (3)

Afimkibart Group I

EXPERIMENTAL

Participants will receive afimkibart via subcutaneous (SC) injection.

Drug: Afimkibart

Afimkibart Group II

EXPERIMENTAL

Participants will receive afimkibart via SC injection.

Drug: Afimkibart

Placebo

PLACEBO COMPARATOR

Participants will receive afimkibart matched placebo via SC injection.

Drug: Placebo

Interventions

Afimkibart DRUG

Afimkibart will be administered as SC injection.

Also known as: PF 06480605, RVT-3101, RO7790121

Afimkibart Group I; Afimkibart Group II

Placebo DRUG

Placebo will be administered as SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (46)

SunValley Arthritis Center Ltd.

Peoria, Arizona, 85381, United States

RECRUITING

Inland Rheumatology Clinical Trials Incorporated

Upland, California, 91786, United States

RECRUITING

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, 33321, United States

RECRUITING

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527, United States

RECRUITING

Accurate Clinical Research Inc.

Lake Charles, Louisiana, 70605, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43203, United States

RECRUITING

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Accurate Clinical Management

Houston, Texas, 77089, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77375, United States

RECRUITING

Tidewater Clinical Research

Chesapeake, Virginia, 23320, United States

RECRUITING

Rheumatic Disease Center

Glendale, Wisconsin, 53217, United States

RECRUITING

Centro Medico Arsema

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

RECRUITING

APRILLUS Asistencia e Investigacion

Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina

RECRUITING

Centro Privado de Medicina Familiar - Mind Out Research

Ciudad Autonoma Buenos Aires, C1417EYH, 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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Nzoz Bif-Med

Bytom, 41-902, Poland

RECRUITING

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

Elbl?g, 82-300, Poland

RECRUITING

Malopolskie Badania Kliniczne

Krakow, 30-002, Poland

RECRUITING

Zespol Poradni Specjalistycznych REUMED

Lublin, 20-607, Poland

RECRUITING

Twoja Przychodnia NCM

Nowa Sól, 67-100, Poland

RECRUITING

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

Warsaw, 02-637, Poland

RECRUITING

Centrum Medyczne Reuma Park

Warsaw, 02-665, Poland

RECRUITING

Reumatop Spolka Jawna

Wroclaw, 52-210, Poland

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29009, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Doncaster Royal Infirmary

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

RECRUITING

North Tyneside General Hospital

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

RECRUITING

Barnet Hospital

Barnet, EN5 3DJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WA45846 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global.rochegenentechtrials@roche.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): October 2, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); PL (8); BE (2); DK (2); FR (5); US (11); DE (2); BR (7); AR (3); IT (1); GB (3)