A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Rocatinlimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 532
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hôpital Erasme
  • Brussels, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Maldegem, Belgium, 9990
    • Dermatologie Maldegem
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin Instituto Brasil de Pesquisa Clinica
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055-450
      • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41820-020
      • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30575-180
      • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
      • Irmandade Da Santa Casa de Misericórdia de Porto Alegre
  • São Paulo
    • Jaú, São Paulo, Brazil, 17201-130
      • Cecip Centro Est Clin Int Paulista
    • Ribeirão Preto, São Paulo, Brazil, 14026-020
      • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
    • São Paulo, São Paulo, Brazil, 01228-200
      • Instituto Pesquisa e Ensino em Saúde Infantil
    • São Paulo, São Paulo, Brazil, 05403-002
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3K 6B8
      • Rejuvenation Dermatology Laser Calgary North
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr SK Siddha Medicine Professional Corporation
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Allergy Research Canada Incorporated
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research, Incorporated
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• Chile
  • Osorno, Chile, 5310644
    • Centro Dermatologico Dermisur
  • Santiago, Chile, 7640881
    • Clinica Dermacross SA
  • Santiago, Chile, 7580206
    • Centro Medico Skinmed Spa
  • Santiago, Chile, 8380465
    • Fundacion Innovacion Cardiovascular
  • Santiago, Chile, 8420383
    • Centro Internacional de Estudios Clinicos
• China
  • Changsha, China, 410007
    • Hunan Childrens Hospital
  • Shenzhen, China, 518038
    • Shenzhen Childrens Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Childrens Hospital Capital Institute of Pediatrics
    • Beijing, Beijing Municipality, China, 100044
      • Peking University Peoples Hospital
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Childrens Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400014
      • Childrens Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital Sun-Yat Sen University
  • Henan
    • Nanyang, Henan, China, 473002
      • Nanyang First Peoples Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430014
      • The Central Hospital of Wuhan
  • Jiangsu
    • Jiangyin, Jiangsu, China, 214400
      • Jiangyin Hospital of Traditional Chinese Medicine
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Dalian Women and Childrens Medical Group
  • Ningxia
    • Yinchuan, Ningxia, China, 750003
      • General Hospital of Ningxia Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Shanghai Skin Disease Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610021
      • Chengdu Second Peoples Hospital
    • Suining, Sichuan, China, 629099
      • Suining Central Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650103
      • Kunming Childrens Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
    • Ningbo, Zhejiang, China, 315010
      • Ningbo NO 2 Hospital
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Central Hospital
• Croatia
  • Ivanić-Grad, Croatia, 10310
    • Special Hospital for Medical Rehabilitation Naftalan
  • Osijek, Croatia, 31000
    • University Hospital Centre Osijek
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Sestre milosrdnice University Hospital Center
  • Zagreb, Croatia, 10000
    • Children s Hospital Zagreb
• France
  • Antony, France, 92160
    • Hopital Prive D Antony
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
  • Marseille, France, 13285
    • Hôpital Saint-Joseph
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes Hotel Dieu
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
  • Rouen, France, 76031
    • Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Bonn, Germany, 53127
    • Universitaetsklinikum Bonn
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Erlangen, Germany, 91054
    • Universitaetsklinikum Erlangen
  • Frankfurt am Main, Germany, 60590
    • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
  • Leipzig, Germany, 04103
    • Velocity Clinical Research
  • Mainz, Germany, 55101
    • Johannes Gutenberg Universitaet Mainz
• Greece
  • Athens, Greece, 11521
    • Athens Naval Hospital
  • Athens, Greece, 11527
    • Thoracic General Hospital Of Athens Sotiria
  • Athens, Greece, 11527
    • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
  • Thessaloniki, Greece, 54643
    • Ippokratio General Hospital of Thessaloniki
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4031
    • Derma-B Egeszsegugyi es Szolgaltato Kft
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
• Israel
  • Bear Sheva, Israel, 8410101
    • Soroka Medical Center
  • Ramat Gan, Israel, 5262000
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center
• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Luigi Vanvitelli
  • Perugia, Italy, 06129
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Torino, Italy, 10126
    • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-0821
      • Central Clinic
  • Chiba
    • Matsudo-shi, Chiba, Japan, 271-0092
      • Miyata Dermatology Clinic
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 819-0373
      • Matsuo Clinic
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8610
      • Asahikawa City Hospital
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Hyōgo
    • Akashi-shi, Hyōgo, Japan, 674-0068
      • Yoshimura Child Clinic
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-0063
      • Katahira Dermatology Urology Clinic
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 231-8682
      • Yokohama City Minato Red Cross Hospital
    • Yokohama, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-0066
      • Jouzan Hihuka Hinyoukika Clinic
    • Kumamoto, Kumamoto, Japan, 862-0950
      • Suizenji Dermatology Clinic
  • Osaka
    • Neyagawa, Osaka, Japan, 572-0838
      • Yoshioka Dermatology Clinic
    • Sakai-shi, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Naoko Dermatology Clinic
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Ntt Medical Center Tokyo
• Mexico
  • Toluca, Mexico, 50090
    • Phylasis Clinicas Research Toluca
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Gdansk, Poland, 80-280
    • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Katowice, Poland, 40-600
    • GynCentrum Sp zoo NZOZ Holsamed
  • Krakow, Poland, 30-002
    • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
  • Krakow, Poland, 31-559
    • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
  • Lodz, Poland, 90-349
    • AppleTreeClinics Network Spzoo
  • Lodz, Poland, 91-495
    • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
  • Lublin, Poland, 20-011
    • Clinical Best Solutions Sp zoo Spolka komandytowa
  • Sosnowiec, Poland, 41-200
    • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
  • Tarnów, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
  • Warsaw, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak Dermatologia
  • Warsaw, Poland, 00-716
    • Klinika Osipowicz and Turkowski Sp zoo
  • Warsaw, Poland, 01-817
    • High Med Przychodnia Specjalistyczna
  • Wroclaw, Poland, 50-450
    • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC
  • San Juan, Puerto Rico, 00909
    • Clinical Research of Puerto Rico
• Romania
  • Bucharest, Romania, 011216
    • Dr Leventer Centre Clinica Dermatologie Bucuresti
  • Cluj-Napoca, Romania, 400431
    • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
  • Cluj-Napoca, Romania, 400105
    • Derma Cluj
• South Korea
  • Ansansi, Gyeonggido, South Korea, 15355
    • Korea University Ansan Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 01830
    • Nowon Eulji Medical Center, Eulji University
  • Seoul, South Korea, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital
  • Seoul, South Korea, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea, 04564
    • National medical center
  • Seoul, South Korea, 07804
    • Ewha Womans University Seoul Hospital
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital De La Santa Creu I Sant Pau
    • Esplugues de Llobregat, Catalonia, Spain, 08950
      • Hospital Sant Joan de Déu
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital
  • Pathum Thani, Thailand, 12120
    • Thammasat University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology and Skin Health Center
    • Cullman, Alabama, United States, 35058
      • AllerVie Clinical Research- Cullman
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials, LLC
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research Inc
    • Fullerton, California, United States, 92831
      • Doc1 Healthcare Systems Incorporated
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Avance Clinical Trials
    • Palmdale, California, United States, 93551
      • Cura Clinical Research
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • Sacramento, California, United States, 95816
      • University of California at Davis Medical Center
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center
    • San Diego, California, United States, 92123
      • University of California at San Diego Rady Childrens Hospital San Diego
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Sherman Oaks, California, United States, 91403
      • Cura Clinical Research Sherman Oaks
  • Colorado
    • Denver, Colorado, United States, 80209
      • Velocity Clinical Research - Denver
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Childrens National Medical Center
  • Florida
    • Brandon, Florida, United States, 33511
      • Clinical Research of Brandon
    • Clearwater, Florida, United States, 33761
      • Academic Alliance in Dermatology - Saint Petersburg Office
    • Coral Springs, Florida, United States, 33071
      • Corazon United States of America, LLC doing business as Life Clinical Trials
    • Delray Beach, Florida, United States, 33484
      • Palm Beach Dermatology Group
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Margate, Florida, United States, 33063
      • Glick Skin Institute
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33176
      • ara Professionals Limited Liability Corporation
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group LLC
    • Miami Lakes, Florida, United States, 33016
      • Angels Clinical Research Institute
    • Miami Lakes, Florida, United States, 33014
      • Deluxe Health Care LLC
    • Orange City, Florida, United States, 32763
      • Optimal Research Sites, LLC
    • Orlando, Florida, United States, 32819
      • Clinical Research Investments
    • Orlando, Florida, United States, 32819
      • Clinical Associates of Orlando Limited Liability Company
    • Tampa, Florida, United States, 33612
      • University Of South Florida
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research Columbus
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC
    • Savannah, Georgia, United States, 31419
      • Divine Dermatology and Aesthetics
    • Thomasville, Georgia, United States, 31792
      • McIntosh Clinic PC
  • Idaho
    • Boise, Idaho, United States, 83706-1345
      • Treasure Valley Medical Research
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University HealthSystem Clinical Trials Center
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Southern Indiana Clinical trials
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center PC
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical
    • Murray, Kentucky, United States, 42071
      • Kentucky Advanced Medical Research LLC
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Aesthetic and Dermatology Center
    • Rockville, Maryland, United States, 20850
      • Derm Associates, PC
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Flint, Michigan, United States, 48532
      • Onyx Clinical Research
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
    • St Louis, Missouri, United States, 63110
      • Saint Louis University
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Somnos Clinical Research
  • Nevada
    • Reno, Nevada, United States, 89509
      • Skin Cancer and Dermatology Institute
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • The Dermatology Center of New Jersey
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico
  • New York
    • Brooklyn, New York, United States, 11211
      • Ace Clinical Trials
    • East Syracuse, New York, United States, 13057
      • Empire Dermatology
    • Jackson Heights, New York, United States, 11372
      • Smart Medical Research Inc
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10016
      • Pioneer Clinical Research New York
    • New York, New York, United States, 10075
      • Cornell University - Weill Cornell Medicine
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • The Bronx, New York, United States, 10467
      • Yeshiva University - Montefiore Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke South Durham
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center LLC
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Epic Medical Research - Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73120
      • Dermatology and Aesthetics of Oklahoma
    • Tulsa, Oklahoma, United States, 74132
      • Dermatology Research Center of Oklahoma, PLLC
    • Tulsa, Oklahoma, United States, 74137
      • Essential Medical Research LLC
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research - Grants Pass
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital, Lifespan
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research
  • Tennessee
    • Morristown, Tennessee, United States, 37813
      • HealthStar Physicians Dermatology
  • Texas
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
    • Cedar Park, Texas, United States, 78613
      • US Dermatology Partners Cedar Park
    • Cypress, Texas, United States, 77429
      • Studies in Dermatology LLC
    • Houston, Texas, United States, 77037
      • MedCare Pharma - Houston
    • Houston, Texas, United States, 77098
      • Tranquil Clinical Research
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • Lubbock, Texas, United States, 79424
      • Long and Harris Dermatology
    • Mesquite, Texas, United States, 75149
      • Sms Clinical Research Limited Liability Company
    • Missouri City, Texas, United States, 77459
      • Sienna Dermatology Research
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • Southlake, Texas, United States, 76092
      • Epiphany Dermatology
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Solutions
  • Utah
    • Murray, Utah, United States, 84107
      • Tanner Clinic
    • Providence, Utah, United States, 84332
      • Dermatology Research of Utah, dba Providence Dermatology
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Virginia
    • Franklin, Virginia, United States, 23851
      • Maria M Ona MD PC
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 12 to < 18 years at Day 1.
• Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
• Body weight ≥ 40 kg at screening.
• History of inadequate response to TCS of medium to higher potency (with or without TCI).
• EASI score ≥ 12 at initial screening.
• EASI score ≥ 16 at Day 1.
• vIGA-AD score ≥ 3.
• ≥10% body surface area of AD involvement.
• Worst pruritus NRS ≥ 4.

Exclusion Criteria:

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

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

  1. Systemic corticosteroids
  2. Non-biologic, non-targeted systemic immunosuppressants
  3. Phototherapy
  4. Oral or Topical Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  1. TCS of any potency
  2. TCI
  3. Topical phosphodiesterase 4 inhibitors
  4. Other topical immunosuppressive agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Dose 1; Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).	Drug: Rocatinlimab; Subcutaneous (SC) injection; Other Names: AMG 451
Experimental: Arm B: Dose 2; Part 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).	Drug: Rocatinlimab; Subcutaneous (SC) injection; Other Names: AMG 451
Experimental: Arm C: Placebo; Part 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).	Drug: Placebo; SC injection
Experimental: Arm D: Open-Label Dose 1; Part 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.	Drug: Rocatinlimab; Subcutaneous (SC) injection; Other Names: AMG 451

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24	Baseline and Week 24
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of EASI 75 at Week 16	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4	Baseline and Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24	Baseline and Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4	Baseline and Week 24
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24	Baseline to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16	Baseline to Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24	Baseline to Week 24
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) Itch Visual Analog Scale (VAS) Score at Week 16	Baseline to Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24	Baseline to Week 24
Change From Baseline in POEM Score at Week 24	Baseline to Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24	Baseline to Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24	Baseline to Week 24
Achievement of a vIGA-AD 0/1 at Week 16	Baseline and Week 16
Achievement of a vIGA-AD Score of 1 with Presence of Only Barely Perceptible Erythema or vIGA-AD Score of 0 (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24	Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24	Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4	Baseline and Week 24
Initiation of rescue therapy for AD at or before Week 16	Baseline to Week 16
Initiation of rescue therapy for AD at or before Week 24	Baseline to Week 24
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8	Baseline and Week 24
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8	Baseline and Week 24
Achievement of a ≥ 8.7-point Reduction from Baseline in Severity SCORAD Score at Week 24 in Participants with Baseline SCORAD Score ≥ 8.7	Baseline and Week 24
Achievement of a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4 in Participants ≥ 16 Years of Age at Enrollment	Baseline and Week 24
Change From Baseline in DLQI Score at Week 24 in Participants ≥ 16 Years of Age at Enrollment	Baseline to Week 24
Change From Baseline in CDLQI Score at Week 24 in Participants < 16 Years of Age at Enrollment	Baseline to Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 4	Baseline and Week 16
Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3	Baseline and Week 24
Achievement of a ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3	Baseline and Week 16

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; AMG 451; KHK4083; Rocatinlimab
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 20210145; 2022-501586-50 (Other Identifier: EUCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No