Atopic DermatitisPhase 3ROCKET-ASTRONCT05704738
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 246 sites in 22 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rocatinlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 532 participants
- Where
- 246 sitesin 22 countries
- Study dates
- 20 Apr 2023to 25 Nov 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- vIGA-AD score ≥ 3.
- ≥10% body surface area of AD involvement.
- Worst pruritus NRS ≥ 4.
Who cannot join
- 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:
- Systemic corticosteroids
- Non-biologic, non-targeted systemic immunosuppressants
- Phototherapy
- Oral or Topical Janus kinase inhibitors
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- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- TCI
- Topical phosphodiesterase 4 inhibitors
- Other topical immunosuppressive agents
Trial locations and contacts
246 sites in 22 countries.
246 sites in 22 countries
United States98 sites
University of New Mexico
Albuquerque, New Mexico, 87102
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Northwest Clinical Research Center
Bellevue, Washington, 98007
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Optima Research
Boardman, Ohio, 44512
Treasure Valley Medical Research
Boise, Idaho, 83706-1345
Equity Medical
Bowling Green, Kentucky, 42104
Clinical Research of Brandon
Brandon, Florida, 33511
The Dermatology Center of New Jersey
Bridgewater, New Jersey, 08807
Ace Clinical Trials
Brooklyn, New York, 11211
US Dermatology Partners Cedar Park
Cedar Park, Texas, 78613
Medical University of South Carolina
Charleston, South Carolina, 29425
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, 73018
Academic Alliance in Dermatology - Saint Petersburg Office
Clearwater, Florida, 33761
Centricity Research Columbus
Columbus, Georgia, 31904
Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, 33071
AllerVie Clinical Research- Cullman
Cullman, Alabama, 35058
Studies in Dermatology LLC
Cypress, Texas, 77429
Palm Beach Dermatology Group
Delray Beach, Florida, 33484
Velocity Clinical Research - Denver
Denver, Colorado, 80209
Henry Ford Health System
Detroit, Michigan, 48202
Duke South Durham
Durham, North Carolina, 27713
Empire Dermatology
East Syracuse, New York, 13057
Onyx Clinical Research
Flint, Michigan, 48532
Maria M Ona MD PC
Franklin, Virginia, 23851
Center for Dermatology Clinical Research Inc
Fremont, California, 94538
Doc1 Healthcare Systems Incorporated
Fullerton, California, 92831
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527
Direct Helpers Research Center
Hialeah, Florida, 33012
MedCare Pharma - Houston
Houston, Texas, 77037
Tranquil Clinical Research
Houston, Texas, 77098
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Axon Clinical Research
Inglewood, California, 90301
Smart Medical Research Inc
Jackson Heights, New York, 11372
Sante Clinical Research
Kerrville, Texas, 78028
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Avance Clinical Trials
Laguna Niguel, California, 92677
Somnos Clinical Research
Lincoln, Nebraska, 68505
Long and Harris Dermatology
Lubbock, Texas, 79424
Glick Skin Institute
Margate, Florida, 33063
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149
Miami Clinical Research
Miami, Florida, 33155
ara Professionals Limited Liability Corporation
Miami, Florida, 33176
Deluxe Health Care LLC
Miami Lakes, Florida, 33014
Savin Medical Group LLC
Miami Lakes, Florida, 33014
Angels Clinical Research Institute
Miami Lakes, Florida, 33016
Sienna Dermatology Research
Missouri City, Texas, 77459
Industrial Medicine Associates Clinical Research Advanced Dermatology Care
Monroe, Louisiana, 71201
HealthStar Physicians Dermatology
Morristown, Tennessee, 37813
Kentucky Advanced Medical Research LLC
Murray, Kentucky, 42071
Tanner Clinic
Murray, Utah, 84107
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
Pioneer Clinical Research New York
New York, New York, 10016
Cornell University - Weill Cornell Medicine
New York, New York, 10075
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Dermatology and Aesthetics of Oklahoma
Oklahoma City, Oklahoma, 73120
Optimal Research Sites, LLC
Orange City, Florida, 32763
Clinical Associates of Orlando Limited Liability Company
Orlando, Florida, 32819
Clinical Research Investments
Orlando, Florida, 32819
Cura Clinical Research
Palmdale, California, 93551
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168
Oregon Health and Science University
Portland, Oregon, 97239
Allcutis Research
Portsmouth, New Hampshire, 03801
Rhode Island Hospital, Lifespan
Providence, Rhode Island, 02903
Dermatology Research of Utah, dba Providence Dermatology
Providence, Utah, 84332
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Rochester Clinical Research
Rochester, New York, 14609
Aesthetic and Dermatology Center
Rockville, Maryland, 20850
Derm Associates, PC
Rockville, Maryland, 20850
Integrative Skin Science and Research
Sacramento, California, 95815
University of California at Davis Medical Center
Sacramento, California, 95816
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
University of California at San Diego Rady Childrens Hospital San Diego
San Diego, California, 92123
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Clinical Science Institute
Santa Monica, California, 90404
Divine Dermatology and Aesthetics
Savannah, Georgia, 31419
Cura Clinical Research Sherman Oaks
Sherman Oaks, California, 91403
NorthShore University HealthSystem Clinical Trials Center
Skokie, Illinois, 60077
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Epiphany Dermatology
Southlake, Texas, 76092
Saint Louis University
St Louis, Missouri, 63110
Pioneer Research Solutions
Sugar Land, Texas, 77479
Coastal Pediatric Research
Summerville, South Carolina, 29486
University of South Florida
Tampa, Florida, 33612
Yeshiva University - Montefiore Medical Center
The Bronx, New York, 10467
McIntosh Clinic PC
Thomasville, Georgia, 31792
Eclipse Clinical Research
Tucson, Arizona, 85745
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
Essential Medical Research LLC
Tulsa, Oklahoma, 74137
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
China24 sites
Childrens Hospital Capital Institute of Pediatrics
Beijing, Beijing Municipality, 100020
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044
Beijing Childrens Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Childrens Hospital
Changsha, 410007
Chengdu Second Peoples Hospital
Chengdu, Sichuan, 610021
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Dalian Women and Childrens Medical Group
Dalian, Liaoning, 116011
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, 510080
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510120
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
Hangzhou, Zhejiang, 310020
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu, 214400
Kunming Childrens Hospital
Kunming, Yunnan, 650103
Nanyang First Peoples Hospital
Nanyang, Henan, 473002
Ningbo NO 2 Hospital
Ningbo, Zhejiang, 315010
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
Shenzhen Childrens Hospital
Shenzhen, 518038
Suining Central Hospital
Suining, Sichuan, 629099
Taizhou Central Hospital
Taizhou, Zhejiang, 318000
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003
Japan16 sites
Yoshimura Child Clinic
Akashi-shi, Hyōgo, 674-0068
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, 070-8610
Matsuo Clinic
Fukuoka, Fukuoka, 819-0373
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Katahira Dermatology Urology Clinic
Kagoshima, Kagoshima-ken, 890-0063
Jouzan Hihuka Hinyoukika Clinic
Kumamoto, Kumamoto, 860-0066
Suizenji Dermatology Clinic
Kumamoto, Kumamoto, 862-0950
Miyata Dermatology Clinic
Matsudo-shi, Chiba, 271-0092
Central Clinic
Nagoya, Aichi-ken, 464-0821
Yoshioka Dermatology Clinic
Neyagawa, Osaka, 572-0838
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, 080-0013
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, 158-0097
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Nomura Dermatology Clinic
Yokohama, Kanagawa, 221-0825
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682
Poland16 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
Gdansk, 80-280
GynCentrum Sp zoo NZOZ Holsamed
Katowice, 40-600
Centrum Medyczne Angelius Provita
Katowice, 40-611
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
Krakow, 30-002
Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
Krakow, 31-559
AppleTreeClinics Network Spzoo
Lodz, 90-349
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, 91-495
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, 20-011
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
Sosnowiec, 41-200
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
Tarnów, 33-100
Klinika Osipowicz and Turkowski Sp zoo
Warsaw, 00-716
High Med Przychodnia Specjalistyczna
Warsaw, 01-817
Klinika Ambroziak Dermatologia
Warsaw, 02-953
Royalderm Agnieszka Nawrocka
Warsaw, 02-962
Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
Wroclaw, 50-450
Brazil11 sites
Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
Belo Horizonte, Minas Gerais, 30575-180
Cecip Centro Est Clin Int Paulista
Jaú, São Paulo, 17201-130
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
Ribeirão Preto, São Paulo, 14026-020
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, 20241-180
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador, Estado de Bahia, 41820-020
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Instituto Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, 01228-200
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-002
Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, Espírito Santo, 29055-450
South Korea11 sites
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
National Medical Center
Seoul, 04564
Kyung Hee University Hospital at Gangdong
Seoul, 05278
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Chung-Ang University Hospital
Seoul, 06973
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441
Ewha Womans University Seoul Hospital
Seoul, 07804
Korea University Guro Hospital
Seoul, 08308
Germany8 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Universitaetsklinikum Bonn
Bonn, 53127
Rosenpark Research GmbH
Darmstadt, 64283
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Erlangen
Erlangen, 91054
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
Frankfurt am Main, 60590
Velocity Clinical Research
Leipzig, 04103
Johannes Gutenberg Universitaet Mainz
Mainz, 55101
France7 sites
Hopital Prive d Antony
Antony, 92160
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, 29200
Hôpital Saint-Joseph
Marseille, 13285
Centre Hospitalier Universitaire de Nantes Hôtel Dieu
Nantes, 44093
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Rouen, 76031
Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
Toulouse, 31059
Canada6 sites
Rejuvenation Dermatology Laser Calgary North
Calgary, Alberta, T3K 6B8
Lynderm Research Inc
Markham, Ontario, L3P 1X3
Dr SK Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
Allergy Research Canada Incorporated
Niagara Falls, Ontario, L2H 1H5
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
XLR8 Medical Research, Incorporated
Windsor, Ontario, N8T 1E6
Belgium5 sites
Hopital Erasme
Brussels, 1070
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Dermatologie Maldegem
Maldegem, 9990
Chile5 sites
Centro Dermatologico Dermisur
Osorno, 5310644
Centro Medico Skinmed Spa
Santiago, 7580206
Clinica Dermacross SA
Santiago, 7640881
Fundacion Innovacion Cardiovascular
Santiago, 8380465
Centro Internacional de Estudios Clinicos
Santiago, 8420383
Croatia5 sites
Special Hospital for Medical Rehabilitation Naftalan
Ivanić-Grad, 10310
University Hospital Centre Osijek
Osijek, 31000
Children s Hospital Zagreb
Zagreb, 10000
Sestre milosrdnice University Hospital Center
Zagreb, 10000
University Hospital Centre Zagreb
Zagreb, 10000
Spain5 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario La Paz
Madrid, 28046
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Greece4 sites
Athens Naval Hospital
Athens, 11521
Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
Athens, 11527
Thoracic General Hospital Of Athens Sotiria
Athens, 11527
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 54643
Hungary4 sites
Clinexpert Kft
Budapest, 1033
Derma-B Egeszsegugyi es Szolgaltato Kft
Debrecen, 4031
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Italy4 sites
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06129
Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, 10126
Taiwan4 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Thailand4 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Thammasat University Hospital
Pathum Thani, 12120
Israel3 sites
Soroka Medical Center
Bear Sheva, 8410101
Sheba Medical Center
Ramat Gan, 5262000
Sourasky Medical Center
Tel Aviv, 6423906
Romania3 sites
Dr Leventer Centre Clinica Dermatologie Bucuresti
Bucharest, 011216
Derma Cluj
Cluj-Napoca, 400105
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, 400431
Puerto Rico2 sites
Clinical Research of Puerto Rico
San Juan, 00909
Gcm Medical Group, Psc
San Juan, 00917
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Rocatinlimab, Placebo
- Keywords
- Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocatinlimabDrug
Also called AMG 451
Subcutaneous (SC) injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Dose 1 | Experimental | 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). Receives: Drug: Rocatinlimab |
| Arm B: Dose 2 | Experimental | 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). Receives: Drug: Rocatinlimab |
| Arm C: Placebo | Experimental | 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). Receives: Drug: Placebo |
| Arm D: Open-Label Dose 1 | Experimental | 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. Receives: Drug: Rocatinlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved EASI 75 at Week 24
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Secondary outcomes (29)
Number of Participants Who Achieved EASI 75 at Week 16
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 16
Number of Participants Who Achieved 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
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved 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
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved ≥ 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
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Measured: Up to Week 16
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
Measured: Up to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Measured: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Measured: Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Measured: Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Measured: Baseline and Week 24
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Measured: Baseline and Week 24
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Measured: Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Change From Baseline in POEM Score at Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Measured: Baseline and Week 24
Number of Participants Who Achieved ≥ 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 AD Skin Pain NRS Score ≥ 4
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Measured: Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Measured: Baseline and Week 16
Number of Participants Who Achieved ≥ 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
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved ≥ 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
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Measured: Baseline and Week 24
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.
Measured: Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.
Measured: Baseline and Week 24
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start20 Apr 2023
- Primary completion27 Feb 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704738
- Sponsor's protocol ID
- 20210145
- Other IDs
- 2022-501586-50
- Acronym
- ROCKET-ASTRO
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2023
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
PubMed 40012373Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.
PubMed 41513913
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05704738
- Acronym / sponsor ID
- ROCKET-ASTRO / 20210145
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Posted 28 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Dose 1 | Experimental | Drug: RocatinlimabPart 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). |
| Arm B: Dose 2 | Experimental | Drug: RocatinlimabPart 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). |
| Arm C: Placebo | Experimental | Drug: PlaceboPart 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). |
| Arm D: Open-Label Dose 1 | Experimental | Drug: RocatinlimabPart 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocatinlimabAlso: AMG 451Subcutaneous (SC) injection | Drug | Arm A: Dose 1, Arm B: Dose 2, Arm D: Open-Label Dose 1 |
| PlaceboSC injection | Drug | Arm C: Placebo |
Primary outcome
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Time frame: Baseline and Week 24
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Number of Participants Who Achieved EASI 75 at Week 24
Time frame: Baseline and Week 24
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
29 secondary outcomes
Number of Participants Who Achieved EASI 75 at Week 16
Time frame: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
Time frame: Baseline and Week 16
Number of Participants Who Achieved 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
Time frame: Baseline and Week 16
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved 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
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 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
Time frame: Baseline and Week 24
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
Time frame: Up to Week 16
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
Time frame: Up to Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Time frame: Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Time frame: Baseline and Week 24
Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Time frame: Baseline and Week 24
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
Time frame: Baseline and Week 24
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Time frame: Baseline and Week 24
Change From Baseline in POEM Score at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 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 AD Skin Pain NRS Score ≥ 4
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Time frame: Baseline and Week 16
Number of Participants Who Achieved ≥ 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
Time frame: Baseline and Week 24
Number of Participants Who Achieved ≥ 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
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Time frame: Baseline and Week 24
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Time frame: Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Time frame: Baseline and Week 24
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40012373Guttman-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.
- Background: PubMed 41513913Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
246 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 246 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 246 sites in United States, China, Japan, Poland, Brazil and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704738, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.