Recruiting
Phase 2

Afimkibart

Sponsor:

Hoffmann-La Roche

Code:

NCT07137598

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Placebo

Study Details

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

Study ID

NCT07137598

Start date

Dec 5, 2025

Status verified date

Aug, 2026

Completion date

Oct 2, 2027

Anticipated

Primary completion date

Apr 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart Group I

Participants will receive afimkibart via subcutaneous (SC) injection.

experimental: Afimkibart Group II

Participants will receive afimkibart via SC injection.

placebo comparator: Placebo

Participants will receive afimkibart matched placebo via SC injection.

Interventions

Afimkibart

Afimkibart will be administered as SC injection.

Placebo

Placebo will be administered as SC injection.

Primary outcome measure

  • Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) [ Time Frame: Baseline, At Week 14 ]

Central Contacts and Locations

Central contacts

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

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

Locations

SunValley Arthritis Center Ltd.

Recruiting

Peoria, Arizona, United States, 85381

University of California Medical Center

Recruiting

La Jolla, California, United States, 92037

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Inland Rheumatology Clinical Trials Incorporated

Recruiting

Upland, California, United States, 91786

West Broward Rheumatology Associates, Inc.

Recruiting

Tamarac, Florida, United States, 33321

Willow Rheumatology and Wellness PLLC

Recruiting

Willowbrook, Illinois, United States, 60527

Accurate Clinical Research Inc.

Recruiting

Lake Charles, Louisiana, United States, 70605

Henry Ford Medical Center- New Center One

Recruiting

Detroit, Michigan, United States, 48202

Equity Medical

Recruiting

The Bronx, New York, United States, 10455

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43203

Altoona Center For Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Precision Comprehensive Clinical Research Solutions

Recruiting

Colleyville, Texas, United States, 76034

Accurate Clinical Management

Recruiting

Houston, Texas, United States, 77089

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

Tidewater Clinical Research

Recruiting

Chesapeake, Virginia, United States, 23320

Rheumatic Disease Center

Recruiting

Glendale, Wisconsin, United States, 53217

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-25.