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RecruitingInterventionalPhase 2

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

NCT ID: NCT07137598Sponsor: Hoffmann-La RocheLast updated: 2026-06-01

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.

Arms & interventions

  • DrugAfimkibart

    Afimkibart will be administered as SC injection.

  • DrugPlacebo

    Placebo will be administered as SC injection.

Outcome measures

Primary

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

    Time frame: Baseline, At Week 14

Secondary

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

    Time frame: At Week 14

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: 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)

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

  • Change from Baseline in ACR20, ACR50 and ACR70 Response Rate

    Time frame: Baseline, At Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 24

  • Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to Week 38

  • Serum Concentration of RO7790121 at Specified Timepoints

    Time frame: Up to Week 38

  • Percentage of Participants With Anti-Drug Antibodies

    Time frame: Baseline, Up to Week 38

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (12)

SunValley Arthritis Center Ltd.

Peoria, Arizona, 85381

Recruiting

Cedars Sinai Medical Center

Los Angeles, California, 90048

Recruiting

Inland Rheumatology Clinical Trials Incorporated

Upland, California, 91786

Recruiting

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, 33321

Recruiting

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, 60527

Recruiting

Accurate Clinical Research Inc.

Lake Charles, Louisiana, 70605

Recruiting

Ohio State University Wexner Medical Center

Columbus, Ohio, 43203

Recruiting

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635

Recruiting

Accurate Clinical Management

Houston, Texas, 77089

Recruiting

DM Clinical Research

Tomball, Texas, 77375

Recruiting

Tidewater Clinical Research

Chesapeake, Virginia, 23320

Recruiting

Rheumatic Disease Center

Glendale, Wisconsin, 53217

Recruiting