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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)
Sponsor: Hoffmann-La Roche
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-12-05
Completion Date
2027-10-02
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Afimkibart
Afimkibart will be administered as SC injection.
Placebo
Placebo will be administered as SC injection.
Locations (32)
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
Ohio State University Wexner Medical Center
Columbus, Ohio, 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
Tidewater Clinical Research
Chesapeake, Virginia, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
UZ Leuven
Leuven, Belgium
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Bispebjerg og Frederiksberg Hospital
Frederiksberg, Denmark
Sjllands Universitetshospital
Kge, Denmark
CHU Strasbourg Hpital Hautepierre
Strasbourg, Bas Rhin, France
Hopital de la Conception
Marseille, Bouches-du-Rhne, France
Hopital Lapeyronie
Montpellier, Herault, France
Hopital Purpan
Toulouse, Lot Et Garonne, France
Hpital Cochin
Paris, France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
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
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warsaw, Poland
Centrum Medyczne Reuma Park
Warsaw, Poland
Reumatop Spolka Jawna
Wroclaw, Poland
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Doncaster Royal Infirmary
Doncaster, South Yorkshire, United Kingdom