A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

Last updated: December 9, 2025
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Rash

Allergy

Dermatitis, Atopic

Treatment

Rocatinlimab

Clinical Study ID

NCT05633355
20210263
2022-001548-99
  • Ages 12-17
  • All Genders

Study Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 12 to < 18 years at day 1.

  • Participant has a diagnosis of AD (according to American Academy of DermatologyConsensus Criteria [Eichenfield, 2014]) that has been present for at least 12 monthsbefore signing of informed consent

  • Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medicallyinadvisable (eg, because of important side effects or safety risks)

  • Eczema Area and Severity Index (EASI) score ≥ 12

  • vIGA-AD score ≥ 3

  • ≥ 10% BSA of AD involvement at day 1 pre-enrollment

Exclusion

Exclusion Criteria:

  • Treatment with a biological product within 12 weeks or 5 half-lives, whichever islonger, prior to Day 1

  • Treatment with any of the following medications or therapies within 4 weeks or 5half-lives, whichever is longer, prior to Day 1:

  • Systemic corticosteroids

  • Systemic immunosuppressants

  • Phototherapy

  • Oral or topical janus kinase inhibitors

  • Treatment with any of the following agents within 1 week before day 1pre-enrollment:

  • Topical PDE4 inhibitors

  • Other topical immunosuppressive agents (not including TCS/TCI)

  • Combination topical agents containing a high- or super-high potencycorticosteroid

Study Design

Total Participants: 187
Treatment Group(s): 1
Primary Treatment: Rocatinlimab
Phase: 3
Study Start date:
January 30, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Cinme - Centro de Investigaciones Metabolicas

    Caba, Buenos Aires C1027AAP
    Argentina

    Site Not Available

  • Cinme - Centro de Investigaciones Metabolicas

    CABA, Buenos Aires 3435907 C1027AAP
    Argentina

    Site Not Available

  • Fundacion Cidea

    Buenos Aires 3435910, Distrito Federal 1121
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires 3435910, Distrito Federal 1425
    Argentina

    Site Not Available

  • Fundacion CIDEA

    Ciudad Autonoma de Buenos Aires, Distrito Federal 1121
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Ciudad Autonoma de Buenos Aires, Distrito Federal 1425
    Argentina

    Site Not Available

  • CTR de Investigaciones Clínicas Inst

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Centro de Investigaciones Clínicas Inst Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clínicas del Instituto Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Diagnostico ABC

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Diagnostico Abc American British Cowdray

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Site Not Available

  • Instituto de Diagnostico ABC

    Rosario 3838583, Santa Fe Province 3836276 2000
    Argentina

    Site Not Available

  • Woden Dermatology

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Woden Dermatology

    Phillip 2153335, Australian Capital Territory 2177478 2606
    Australia

    Site Not Available

  • The Skin Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Premier Specialists

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • The Skin Hospital

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Premier Specialists

    Kogarah 2161185, New South Wales 2155400 2217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards 8029783, New South Wales 2155400 2065
    Australia

    Site Not Available

  • The Skin Centre

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • The Skin Centre

    Benowa 2176127, Queensland 2152274 4217
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Monash Childrens Hospital

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Institute for Skin Health and Immunity

    Mitcham, Victoria 3132
    Australia

    Site Not Available

  • Monash Childrens Hospital

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Institute for Skin Health and Immunity

    Mitcham 2157410, Victoria 2145234 3132
    Australia

    Site Not Available

  • Universidade Federal do Parana

    Curitiba, Paraná 80060-240
    Brazil

    Site Not Available

  • Universidade Federal do Parana

    Curitiba 3464975, Paraná 3455077 80060-240
    Brazil

    Site Not Available

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande Do Sul 90160-093
    Brazil

    Site Not Available

  • Hospital Ernesto Dornelles

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90160-093
    Brazil

    Site Not Available

  • Fundacao Abc - Centro Univ Fmabc

    Santo Andre, São Paulo 09060-870
    Brazil

    Site Not Available

  • Fundacao do Abc - Centro Universitario Fmabc

    Santo Andre, São Paulo 09060-870
    Brazil

    Active - Recruiting

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Sao Paulo, São Paulo 01308-050
    Brazil

    Site Not Available

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo 12243-280
    Brazil

    Active - Recruiting

  • Ispem-Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo 12243-280
    Brazil

    Site Not Available

  • Fundacao Abc - Centro Univ Fmabc

    Santo André 3449701, São Paulo 3448433 09060-870
    Brazil

    Site Not Available

  • Ispem-Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos 3448636, São Paulo 3448433 12243-280
    Brazil

    Site Not Available

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo 3448439, São Paulo 3448433 01308-050
    Brazil

    Site Not Available

  • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

    São Paulo, 06454-010
    Brazil

    Site Not Available

  • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

    São Paulo 3448439, 06454-010
    Brazil

    Site Not Available

  • Dermatology Research Institute Incorporated

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Stratica Dermatology

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Vida Clinical Research

    Edmonton, Alberta T6H 4J8
    Canada

    Site Not Available

  • Dermatology Research Institute Incorporated

    Calgary 5913490, Alberta 5883102 T2J 7E1
    Canada

    Site Not Available

  • Stratica Dermatology

    Edmonton 5946768, Alberta 5883102 T5K 1X3
    Canada

    Site Not Available

  • Vida Clinical Research

    Edmonton 5946768, Alberta 5883102 T6H 4J8
    Canada

    Site Not Available

  • Winnipeg Clinic Dermatology Research

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Winnipeg Clinic Dermatology Research

    Winnipeg 6183235, Manitoba 6065171 R3C 0N2
    Canada

    Site Not Available

  • Skincare Studio

    St. John's, Newfoundland and Labrador A1E 1V4
    Canada

    Site Not Available

  • Skincare Studio

    St. John's 6324733, Newfoundland and Labrador 6354959 A1E 1V4
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Halton Pediatric Allergy

    Burlington, Ontario L7L 6W6
    Canada

    Site Not Available

  • LEADER Research

    Hamilton, Ontario L8L 3C3
    Canada

    Site Not Available

  • Triple A Lab

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • JRB Research Incorporated

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • Toronto Research Centre Inc

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie 5894171, Ontario 6093943 L4M 7G1
    Canada

    Site Not Available

  • Halton Pediatric Allergy

    Burlington 5911592, Ontario 6093943 L7L 6W6
    Canada

    Site Not Available

  • LEADER Research

    Hamilton 5969782, Ontario 6093943 L8L 3C3
    Canada

    Site Not Available

  • Triple A Lab

    Hamilton 5969782, Ontario 6093943 L8S 1G5
    Canada

    Site Not Available

  • JRB Research Incorporated

    Ottawa 6094817, Ontario 6093943 K2C 3N2
    Canada

    Site Not Available

  • SKiN Centre for Dermatology

    Peterborough 6101645, Ontario 6093943 K9J 5K2
    Canada

    Site Not Available

  • FACET Dermatology

    Toronto 6167865, Ontario 6093943 M4E 1R7
    Canada

    Site Not Available

  • Toronto Research Centre Inc

    Toronto 6167865, Ontario 6093943 M3H 5Y8
    Canada

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

  • Korea University Ansan Hospital

    Ansansi, Gyeonggido, 15355
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Seoul Hospital

    Seoul, 07804
    Korea, Republic of

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • National Medical Center

    Seoul, 04564
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • The Catholic Univ of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Ansansi, Gyeonggido 1846918, 15355
    South Korea

    Site Not Available

  • Chung-Ang University Hospital

    Seoul 1835848, 06973
    South Korea

    Site Not Available

  • Ewha Womans University Seoul Hospital

    Seoul 1835848, 07804
    South Korea

    Site Not Available

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul 1835848, 07441
    South Korea

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul 1835848, 05278
    South Korea

    Site Not Available

  • National Medical Center

    Seoul 1835848, 04564
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul 1835848, 06591
    South Korea

    Site Not Available

  • Bezmialem Vakif Universitesi Hastanesi

    Istanbul, 34093
    Turkey

    Site Not Available

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi

    Izmir, 35620
    Turkey

    Site Not Available

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    Kayseri, 38030
    Turkey

    Site Not Available

  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55200
    Turkey

    Site Not Available

  • Bezmialem Vakif Universitesi Hastanesi

    Istanbul 745044, 34093
    Turkey (Türkiye)

    Site Not Available

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Site Not Available

  • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi

    Izmir 311046, 35620
    Turkey (Türkiye)

    Site Not Available

  • Erciyes Universitesi Tip Fakultesi Hastanesi

    Kayseri 308464, 38030
    Turkey (Türkiye)

    Site Not Available

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun 740264, 55200
    Turkey (Türkiye)

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol 2654675, BS2 8BJ
    United Kingdom

    Site Not Available

  • Velocity Clinical Research, High Wycombe

    High Wycombe, HP11 2QW
    United Kingdom

    Site Not Available

  • Velocity Clinical Research, High Wycombe

    High Wycombe 2646914, HP11 2QW
    United Kingdom

    Site Not Available

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Alder Hey Childrens Hospital

    Liverpool 2644210, L12 2AP
    United Kingdom

    Site Not Available

  • St Thomas Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital

    London, E11 1NR
    United Kingdom

    Site Not Available

  • St Thomas Hospital

    London 2643743, SE1 7EH
    United Kingdom

    Site Not Available

  • Whipps Cross University Hospital

    London 2643743, E11 1NR
    United Kingdom

    Site Not Available

  • Carn to Coast Health Centres

    Redruth, TR16 4ET
    United Kingdom

    Site Not Available

  • Carn to Coast Health Centres

    Redruth 2639524, TR16 4ET
    United Kingdom

    Site Not Available

  • Phoenix Childrens Hosptial

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Medical Advancement Centers of Arizona

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Phoenix Childrens Hosptial

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Medical Advancement Centers of Arizona

    Tempe 5317058, Arizona 5551752 85283
    United States

    Site Not Available

  • Dermatology Trial Associates

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Dermatology Trial Associates

    Bryant 4103448, Arkansas 4099753 72022
    United States

    Site Not Available

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of California Irvine

    Irvine 5359777, California 5332921 92697
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles 5368361, California 5332921 90024
    United States

    Site Not Available

  • Manlio Dermatology

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • ARA Professionals Limited Liability Corporation

    Miami, Florida 33176
    United States

    Site Not Available

  • ARA Professionals llc

    Miami, Florida 33176
    United States

    Site Not Available

  • Palm Springs Community Health Center

    Miami, Florida 33014
    United States

    Site Not Available

  • Deluxe Health Care LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Manlio Dermatology

    Kissimmee 4160983, Florida 4155751 34741
    United States

    Site Not Available

  • ARA Professionals Limited Liability Corporation

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • Palm Springs Community Health Center

    Miami 4164138, Florida 4155751 33014
    United States

    Site Not Available

  • Deluxe Health Care LLC

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Bluegrass Allergy Care

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Bluegrass Allergy Care

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Site Not Available

  • Windsor Dermatology dba Eczema Treatment Center of New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Windsor Dermatology dba Eczema Treatment Center of New Jersey

    East Windsor 8354649, New Jersey 5101760 08520
    United States

    Site Not Available

  • Smart Medical Research Inc

    Jackson Heights, New York 11372
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Smart Medical Research Inc

    Jackson Heights 5122477, New York 5128638 11372
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Auni Allergy

    Findlay, Ohio 45840
    United States

    Site Not Available

  • Auni Allergy

    Findlay 5153924, Ohio 5165418 45840
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland 5746545, Oregon 5744337 97201
    United States

    Site Not Available

  • DermDox Dermatology, LLC

    Sugarloaf, Pennsylvania 18201
    United States

    Site Not Available

  • DermDox Dermatology, LLC

    Sugarloaf 13494940, Pennsylvania 6254927 18249
    United States

    Site Not Available

  • Driscoll Childrens Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Modern Research Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Site Not Available

  • Driscoll Childrens Hospital

    Corpus Christi 4683416, Texas 4736286 78411
    United States

    Site Not Available

  • Modern Research Associates

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston 4699066, Texas 4736286 77004
    United States

    Site Not Available

  • University of Utah MidValley Dermatology

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Utah MidValley Dermatology

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

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