A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06863961
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-04-01
2026-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Afimkibart Group I
Participants will receive afimkibart via subcutaneous (SC) injection.
Afimkibart
Afimkibart will be administered as SC injection.
Afimkibart Group II
Participants will receive afimkibart via SC injection.
Afimkibart
Afimkibart will be administered as SC injection.
Afimkibart Group III
Participants will receive afimkibart via SC injection.
Afimkibart
Afimkibart will be administered as SC injection.
Placebo
Participants will receive placebo via SC injection.
Placebo
Placebo will be administered as SC injection.
Interventions
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Afimkibart
Afimkibart will be administered as SC injection.
Placebo
Placebo will be administered as SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe AD
* At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study
Exclusion Criteria
* IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
* Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
* Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
* Acquired or congenital immunodeficiency
* Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of California Los Angeles
Los Angeles, California, United States
Dermatology Research Associate
Los Angeles, California, United States
Suncoast Research Associates LLC - ERN - PPDS
Doral, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Hamilton Research, LLC
Alpharetta, Georgia, United States
Dermatology Affiliates Research Institute, LLC
Atlanta, Georgia, United States
Dawes Fretzin Clinical Res LLC
Indianapolis, Indiana, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
Care Access Research - Hoboken
Hoboken, New Jersey, United States
Weill Cornell Medicine
New York, New York, United States
Centricity Research Dublin
Dublin, Ohio, United States
DOCS Clinical Research - Springfield
Springfield, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Best Skin Research LLC
Camp Hill, Pennsylvania, United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Cumberland Skin Center for Clinical Research LLC
Hermitage, Tennessee, United States
Arlington Research Center
Arlington, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Reveal Research Institute
Dallas, Texas, United States
Care Access Research - Arlington
Arlington, Virginia, United States
Centro de Pesquisas da Clínica IBIS
Salvador, Estado de Bahia, Brazil
Centro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
Centro de Pesquisa São Lucas
Campinas, São Paulo, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, , Brazil
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
CARe Clinic
Red Deer, Alberta, Canada
Centricity Research
London, Ontario, Canada
DermEffects
London, Ontario, Canada
Lynde Institute for Dermatology
Markham, Ontario, Canada
DermEdge
Mississauga, Ontario, Canada
Ryan Clinical Research Inc
Newmarket, Ontario, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Hopital Charles Nicolle
Rouen, Nord, France
Hopital Saint Louis
Cedex 10, Paris, France
Klinisches Studienzentrum
Bad Bentheim, Lower Saxony, Germany
DRK Krankenhaus Chemnitz-Rabenstein
Chemnitz, Saxony, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, Saxony-Anhalt, Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Dermatologikum Hamburg GmbH
Hamburg, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Emilia-Romagna, Italy
Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)
Catania, Sicily, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, The Marches, Italy
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Centrum Medyczne Pratia Katowice I
Katowice, , Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, , Poland
Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski
Krakw, , Poland
Dermoklinika
Lodz, , Poland
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
Rzeszów, , Poland
LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
Szczecin, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Royalderm
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Complejo Hospitalario Universitario de Santiago.
Santiago de Compostela, LA Coruna, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Reference Study ID Number: CS45570 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
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2024-515494-95-00
Identifier Type: OTHER
Identifier Source: secondary_id
CS45570
Identifier Type: -
Identifier Source: org_study_id