A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

Last updated: May 8, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

2

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Atopic Dermatitis

Treatment

RO7790121

Placebo

Afimkibart

Clinical Study ID

NCT06863961
CS45570
2024-515494-95-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria atleast 1 year prior to screening

  • Moderate to severe AD

  • At least once daily use of an additive-free, bland emollient for at least 7 daysprior to the baseline visit and during the study

Exclusion

Exclusion Criteria:

  • Evidence of other skin conditions that would interfere with the assessment of AD,including, but not limited to, for example cutaneous T-cell lymphoma, allergiccontact dermatitis

  • IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasalcorticosteroids are allowed) within 4 weeks of the baseline visit and during thestudy

  • Topical treatment for AD including, but not limited to topical corticosteroids,topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescriptionmoisturizers 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 withparenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2weeks prior to baseline

  • Acquired or congenital immunodeficiency

  • Systemic therapies that are also used in the treatment of AD, including, but notlimited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4weeks of the baseline visit and during the study

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: RO7790121
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
February 03, 2027

Connect with a study center

  • Centro de Pesquisas da Clínica IBIS

    Salvador, Estado de Bahia 41820-020
    Brazil

    Site Not Available

  • Centro de Pesquisas da Clínica IBIS

    Salvador 3450554, Estado de Bahia 3471168 41820-020
    Brazil

    Site Not Available

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba, Paraná 80030-110
    Brazil

    Site Not Available

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba 3464975, Paraná 3455077 80030-110
    Brazil

    Site Not Available

  • Hospital de Clnicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90050-170
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90050-170
    Brazil

    Site Not Available

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, São Paulo 18618-686
    Brazil

    Site Not Available

  • Centro de Pesquisa São Lucas

    Campinas, São Paulo 13034-685
    Brazil

    Site Not Available

  • HMCG - Hospital e Maternidade Dr. Christovo da Gama

    Santo Andr, São Paulo 09030-010
    Brazil

    Site Not Available

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu 3469136, São Paulo 3448433 18618-686
    Brazil

    Site Not Available

  • Centro de Pesquisa São Lucas

    Campinas 3467865, São Paulo 3448433 13034-685
    Brazil

    Site Not Available

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, 20241-180
    Brazil

    Site Not Available

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro 3451190, 20241-180
    Brazil

    Site Not Available

  • Dermatology Research Institute Inc.

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • CARe Clinic

    Red Deer, Alberta T4P-1K4
    Canada

    Site Not Available

  • Dermatology Research Institute Inc.

    Calgary 5913490, Alberta 5883102 T2J 7E1
    Canada

    Site Not Available

  • CARe Clinic

    Red Deer 6118158, Alberta 5883102 T4P-1K4
    Canada

    Site Not Available

  • Centricity Research

    London, Ontario N6A 2C2
    Canada

    Site Not Available

  • DermEffects

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Lynde Institute for Dermatology

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • DermEdge

    Mississauga, Ontario L4Y4C5
    Canada

    Site Not Available

  • Ryan Clinical Research Inc

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Centricity Research

    London 6058560, Ontario 6093943 N6A 2C2
    Canada

    Active - Recruiting

  • DermEffects

    London 6058560, Ontario 6093943 N6H5L5
    Canada

    Site Not Available

  • Lynde Institute for Dermatology

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Site Not Available

  • DermEdge

    Mississauga 6075357, Ontario 6093943 L4Y4C5
    Canada

    Site Not Available

  • Ryan Clinical Research Inc

    Newmarket 6087701, Ontario 6093943 L3Y 5G8
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Québec 6325494, G1W 4R4
    Canada

    Site Not Available

  • Hopital Charles Nicolle

    Rouen, Nord 76031
    France

    Site Not Available

  • Hopital Charles Nicolle

    Rouen 2982652, Nord 76031
    France

    Site Not Available

  • Hopital Saint Louis

    Cedex 10, Paris 75010
    France

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg 79104
    Germany

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79104
    Germany

    Site Not Available

  • Klinisches Studienzentrum

    Bad Bentheim, Lower Saxony 48455
    Germany

    Site Not Available

  • Klinisches Studienzentrum

    Bad Bentheim 2953552, Lower Saxony 2862926 48455
    Germany

    Site Not Available

  • Hautmedizin Saar

    Merzig, Saarland 66663
    Germany

    Site Not Available

  • DRK Krankenhaus Chemnitz-Rabenstein

    Chemnitz, Saxony 09117
    Germany

    Site Not Available

  • DRK Krankenhaus Chemnitz-Rabenstein

    Chemnitz 2940132, Saxony 2842566 09117
    Germany

    Site Not Available

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, Saxony-Anhalt 06484
    Germany

    Site Not Available

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg 2851465, Saxony-Anhalt 2842565 06484
    Germany

    Site Not Available

  • CRS Clinical Research Services Kiel GmbH

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • CRS Clinical Research Services Kiel GmbH

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

  • Dermatologikum Hamburg GmbH

    Hamburg, 20354
    Germany

    Site Not Available

  • Dermatologikum Hamburg GmbH

    Hamburg 2911298, 20354
    Germany

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Emilia-Romagna 00168
    Italy

    Site Not Available

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milan, Lombardy 20144
    Italy

    Site Not Available

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milan 3173435, Lombardy 3174618 20144
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)

    Catania, Sicily 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)

    Catania 2525068, Sicily 2523119 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, The Marches 60126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona 3183089, The Marches 3174004 60126
    Italy

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia 3099424, 81-338
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-081
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice I

    Katowice 3096472, 40-081
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011
    Poland

    Site Not Available

  • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

    Krakow, 30-002
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow 3094802, 31-011
    Poland

    Site Not Available

  • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

    Krakw, 30-002
    Poland

    Site Not Available

  • Dermoklinika

    Lodz, 90-436
    Poland

    Site Not Available

  • Dermoklinika

    Lodz 3093133, 90-436
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów 759734, 35-055
    Poland

    Site Not Available

  • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

    Szczecin, 70-332
    Poland

    Site Not Available

  • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

    Szczecin 3083829, 70-332
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun

    Torun 3083271, 87-100
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-872
    Poland

    Site Not Available

  • Royalderm

    Warsaw, 02-962
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warsaw 756135, 02-953
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warsaw 756135, 00-872
    Poland

    Site Not Available

  • Royalderm

    Warsaw 756135, 02-962
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw 756135, 04-501
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa

    Warszawa, 00-874
    Poland

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna 15706
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela 3109642, LA Coruna 15706
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, Navarre 31008
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • The Center for Dermatology Clinical Research

    Fremont, California 94538
    United States

    Site Not Available

  • Dermatology Research Associate

    Los Angeles, California 90045
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90024
    United States

    Site Not Available

  • Dermatology Research Associate

    Los Angeles 5368361, California 5332921 90045
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles 5368361, California 5332921 90024
    United States

    Site Not Available

  • Suncoast Research Associates LLC - ERN - PPDS

    Doral, Florida 33172
    United States

    Site Not Available

  • Suncoast Research Associates LLC - ERN - PPDS

    Miami, Florida 33173
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa, Florida 33615
    United States

    Site Not Available

  • Suncoast Research Associates LLC - ERN - PPDS

    Doral 4153471, Florida 4155751 33172
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa 4174757, Florida 4155751 33615
    United States

    Site Not Available

  • Hamilton Research, LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Dermatology Affiliates Research Institute, LLC

    Atlanta, Georgia 30305
    United States

    Site Not Available

  • Hamilton Research, LLC

    Alpharetta 4179574, Georgia 4197000 30022
    United States

    Site Not Available

  • Dermatology Affiliates Research Institute, LLC

    Atlanta 4180439, Georgia 4197000 30305
    United States

    Site Not Available

  • Dawes Fretzin Clinical Res LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Dawes Fretzin Clinical Res LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Regents of the University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Regents of the University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Care Access Research - Hoboken

    Hoboken, New Jersey 07030
    United States

    Site Not Available

  • Care Access Research - Hoboken

    Hoboken 5099133, New Jersey 5101760 07030
    United States

    Site Not Available

  • Forest Hill Dermatology Group

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10075
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • Centricity Research Dublin

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Centricity Research Dublin

    Dublin, Ohio 43016
    United States

    Site Not Available

  • DOCS Clinical Research - Springfield

    Springfield, Ohio 45505
    United States

    Site Not Available

  • Centricity Research Dublin

    Dublin 5152333, Ohio 5165418 43016
    United States

    Site Not Available

  • DOCS Clinical Research - Springfield

    Springfield 4525353, Ohio 5165418 45505
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73170
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Best Skin Research LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • DermDox Centers for Dermatology

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Best Skin Research LLC

    Camp Hill 5182928, Pennsylvania 6254927 17011
    United States

    Site Not Available

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Cumberland Skin Center for Clinical Research LLC

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Goodlettsville Dermatology Research

    Goodlettsville 4625282, Tennessee 4662168 37072
    United States

    Site Not Available

  • Cumberland Skin Center for Clinical Research LLC

    Hermitage 4628929, Tennessee 4662168 37076
    United States

    Site Not Available

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Site Not Available

  • Modern Research Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Reveal Research Institute

    Dallas, Texas 75235
    United States

    Site Not Available

  • Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLC

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Arlington Research Center

    Arlington 4671240, Texas 4736286 76011
    United States

    Site Not Available

  • Modern Research Associates

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Reveal Research Institute

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Care Access Research - Arlington

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Care Access Research - Arlington

    Arlington 4744709, Virginia 6254928 22206
    United States

    Site Not Available

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