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)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT07137598

Run by

Hoffmann-La Roche

People needed

160

Starts

2025-12-05

Expected to finish

2027-10-08

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of California Medical Center — La Jolla, California, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Inland Rheumatology Clinical Trials Incorporated — Upland, California, United States (enrolling)
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States (enrolling)
• Willow Rheumatology and Wellness PLLC — Willowbrook, Illinois, United States (enrolling)
• Accurate Clinical Research Inc. — Lake Charles, Louisiana, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States (enrolling)
• Accurate Clinical Management — Houston, Texas, United States (enrolling)
• DM Clinical Research — Tomball, Texas, United States (enrolling)
• Tidewater Clinical Research — Chesapeake, Virginia, United States (enrolling)
• Rheumatic Disease Center — Glendale, Wisconsin, United States (enrolling)
• Centro Medico Arsema — Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Buenos Aires, Argentina (enrolling)
• APRILLUS Asistencia e Investigacion — Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Centro Privado de Medicina Familiar - Mind Out Research — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina (enrolling)
• HUB Erasme — Brussels, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília, Federal District, Brazil (enrolling)
• IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Cuiab, Mato Grosso, Brazil (enrolling)
• Centro Mineiro de Pesquisa - CMIP — Juiz de Fora, Minas Gerais, Brazil (enrolling)
• Centro de Estudos em Terapias Inovadoras ? CETI — Curitiba, Paraná, Brazil (enrolling)
• SunValley Arthritis Center Ltd. — Peoria, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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