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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 · Hoffmann-La Roche
In plain English
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Official title
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
About this study
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 criteria
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 target: 160 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-05
Estimated completion: 2027-10-02
Last updated: 2026-04-03
Interventions
Drug: AfimkibartDrug: Placebo
Primary outcomes
- • Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) (Baseline, At Week 14)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WA45846 https://forpatients.roche.com/ · contact · global.rochegenentechtrials@roche.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (32)
SunValley Arthritis Center Ltd.Recruiting
Peoria, Arizona, United States
Inland Rheumatology Clinical Trials IncorporatedRecruiting
Upland, California, United States
West Broward Rheumatology Associates, Inc.Recruiting
Tamarac, Florida, United States
Willow Rheumatology and Wellness PLLCRecruiting
Willowbrook, Illinois, United States
Accurate Clinical Research Inc.Recruiting
Lake Charles, Louisiana, United States
Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
Altoona Center For Clinical ResearchRecruiting
Duncansville, Pennsylvania, United States
Accurate Clinical ManagementRecruiting
Houston, Texas, United States
DM Clinical ResearchRecruiting
Tomball, Texas, United States
Tidewater Clinical ResearchRecruiting
Chesapeake, Virginia, United States
Rheumatic Disease CenterRecruiting
Glendale, Wisconsin, United States
UZ LeuvenRecruiting
Leuven, Belgium
L2IP ?Instituto de Pesquisas Clínicas Ltda.Recruiting
Brasília, Federal District, Brazil
Bispebjerg og Frederiksberg HospitalRecruiting
Frederiksberg, Denmark
Sjllands UniversitetshospitalRecruiting
Kge, Denmark
CHU Strasbourg Hpital HautepierreRecruiting
Strasbourg, Bas Rhin, France
Hopital de la ConceptionRecruiting
Marseille, Bouches-du-Rhne, France
Hopital LapeyronieRecruiting
Montpellier, Herault, France
Hopital PurpanRecruiting
Toulouse, Lot Et Garonne, France
Hpital CochinRecruiting
Paris, France
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Lazio, Italy
Nzoz Bif-MedRecruiting
Bytom, Poland
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka PartneRecruiting
Elbl?g, Poland
Malopolskie Badania KliniczneRecruiting
Krakow, Poland
Zespol Poradni Specjalistycznych REUMEDRecruiting
Lublin, Poland
Twoja Przychodnia NCMRecruiting
Nowa Sól, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory ReicherRecruiting
Warsaw, Poland
Centrum Medyczne Reuma ParkRecruiting
Warsaw, Poland
Reumatop Spolka JawnaRecruiting
Wroclaw, Poland
Hospital Regional Universitario de MalagaRecruiting
Málaga, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Doncaster Royal InfirmaryRecruiting
Doncaster, South Yorkshire, United Kingdom