RecruitingPhase 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 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


Sponsor

Hoffmann-La Roche

Enrollment

160 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria15

  • 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

Interventions

DRUGAfimkibart

Afimkibart will be administered as SC injection.

DRUGPlacebo

Placebo will be administered as SC injection.


Locations(23)

SunValley Arthritis Center Ltd.

Peoria, Arizona, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, United States

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States

Accurate Clinical Research Inc.

Lake Charles, Louisiana, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Accurate Clinical Management

Houston, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Rheumatic Disease Center

Glendale, Wisconsin, United States

UZ Leuven

Leuven, Belgium

Bispebjerg og Frederiksberg Hospital

Frederiksberg, Denmark

CHU Strasbourg Hpital Hautepierre

Strasbourg, Bas Rhin, France

Hopital de la Conception

Marseille, Bouches-du-Rhne, France

Hopital Lapeyronie

Montpellier, Herault, France

Hpital Cochin

Paris, Paris, France

Nzoz Bif-Med

Bytom, Poland

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

Elbl?g, Poland

Malopolskie Badania Kliniczne

Krakow, Poland

Zespol Poradni Specjalistycznych REUMED

Lublin, Poland

Twoja Przychodnia NCM

Nowa Sól, Poland

Centrum Medyczne Reuma Park

Warsaw, Poland

Reumatop Spolka Jawna

Wroclaw, Poland

Hospital Universitario Virgen Macarena

Seville, Spain

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NCT07137598


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