A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
ROCKET-Horizon
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
2 other identifiers
interventional
726
20 countries
189
Brief Summary
The co-primary objectives of the study are to:
- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
- Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedStudy Start
First participant enrolled
December 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2024
CompletedApril 3, 2025
April 1, 2025
1.5 years
December 7, 2022
April 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
Baseline and Week 24
Secondary Outcomes (28)
Achievement of EASI 75 at Week 16
Baseline and Week 16
Achievement of vIGA-AD 0/1 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
- +23 more secondary outcomes
Study Arms (2)
Rocatinlimab
EXPERIMENTALRocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo
PLACEBO COMPARATORPlacebo Q4W for 24 weeks with a loading dose at Week 2.
Interventions
Rocatinlimab will be administered through a subcutaneous (SC) injection.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS (Topical Corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 4
You may not qualify if:
- 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
- Systemic immunosuppressants
- Phototherapy
- Oral or topical Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- TCI
- Topical phosphodiesterase type 4 (PDE4) inhibitors
- Other topical immunosuppressive agents
- Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (197)
Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260, United States
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, 72703, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Velocity Clinical Research Chula Vista
Chula Vista, California, 91911, United States
West Coast Research LLC
Dublin, California, 94568, United States
California Dermatology and Clinical Research Institute
Encinitas, California, 92024, United States
Center for Dermatology Clinical Research Inc
Fremont, California, 94538, United States
Velocity Clinical Research - San Diego
La Mesa, California, 91942, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606, United States
Cura Clinical Research
Palmdale, California, 93551, United States
University of California at San Francisco, Dermatology Clinic at Mount Zion
San Francisco, California, 94115, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Clarity Dermatology
Castle Rock, Colorado, 80109, United States
Velocity Clinical Research - Denver
Denver, Colorado, 80209, United States
Foxhall Research Center
Washington D.C., District of Columbia, 20016, United States
Renaissance Research and Medical Group
Cape Coral, Florida, 33991, United States
Driven Research LLC
Coral Gables, Florida, 33134, United States
Saint Jude Clinical Research
Doral, Florida, 33172, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Glick Skin Institute
Margate, Florida, 33063, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Innovation Medical Research Center Inc
Palmetto Bay, Florida, 33157, United States
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
Advanced Medical Research PC
Sandy Springs, Georgia, 30328, United States
Sneeze, Wheeze, and Itch Associates, LLC
Normal, Illinois, 61761, United States
The South Bend Clinic LLP
South Bend, Indiana, 46617, United States
Options Research Group LLC
West Lafayette, Indiana, 47906, United States
Dermatology and Skin Cancer Center of Overland Park
Overland Park, Kansas, 66223, United States
DS Research
Louisville, Kentucky, 40241, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, 42071, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135, United States
Wendy Sadoff MD Dermatology PC
Farmington Hills, Michigan, 48334, United States
Revival Research Institute LLC
Troy, Michigan, 48084, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Advanced Dermatology of the Midlands
Omaha, Nebraska, 68144, United States
James Del Rosso Dermatology Research
Las Vegas, Nevada, 89117, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Weiss Medical
Riverdale, New Jersey, 07457, United States
Corning Center For Clinical Research
Horseheads, New York, 14845, United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415, United States
Crystal Run Healthcare
Monroe, New York, 10950, United States
Ace Clinical Trials
New York, New York, 10022, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
OptiSkin Medical
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke South Durham
Durham, North Carolina, 27713, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, 45236, United States
The Ohio State University Dermatology East
Gahanna, Ohio, 43230, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
Warwick, Rhode Island, 02886, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
US Dermatology Partners Cedar Park
Cedar Park, Texas, 78613, United States
Alina Clinical Trials, LLC
Dallas, Texas, 75225, United States
Zenos Clinical Research, LLC
Dallas, Texas, 75230, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MedCare Pharma - Houston
Houston, Texas, 77037, United States
FMCScience LLC
Lampasas, Texas, 76550, United States
Epic Clinical Research Incorporated
Lewisville, Texas, 75057, United States
Sienna Dermatology Research
Missouri City, Texas, 77459, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Andante Research
San Antonio, Texas, 78229, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
University of Utah MidValley Dermatology
Murray, Utah, 84107, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
MultiCare Institute for Research and Innovation
Spokane, Washington, 99202, United States
St George Dermatology and Skin Cancer Centre
Darlinghurst, New South Wales, 2010, Australia
Premier Specialists
Kogarah, New South Wales, 2217, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Skin Health Institute
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Hopital Erasme
Brussels, 1070, Belgium
Clinique Andre Renard
Herstal, 4040, Belgium
Dermatologie Maldegem
Maldegem, 9990, Belgium
CETI - Centro de Estudo em Terapias Inovadoras
Curitiba, Paraná, 80030-110, Brazil
Centro Multidisciplinar de Estudos Clinicos - CEMEC
São Bernardo do Campo, São Paulo, 09715-090, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280, Brazil
Beacon Dermatology
Calgary, Alberta, T3E 0B2, Canada
Doctor Chih-Ho Hong Medical Incorporated
Surrey, British Columbia, V3R 6A7, Canada
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9, Canada
Lynderm Research Inc
Markham, Ontario, L3P 1X3, Canada
The Centre for Clinical Trials Inc
Oakville, Ontario, L6J 7W5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
Research Toronto
Toronto, Ontario, M4W 2N4, Canada
XLR8 Medical Research, Incorporated
Windsor, Ontario, N8T 1E6, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7, Canada
Clinique Dermatologique de Sherbrooke
Sherbrooke, Quebec, J1G 1X9, Canada
Kozni ambulance Kutna Hora sro
Kutná Hora, 284 01, Czechia
Nemocnice Novy Jicin as
Nový Jičín, 741 01, Czechia
CCR Czech as
Pardubice, 530 02, Czechia
Fakultni nemocnice Plzen
Pilsen, 305 99, Czechia
Kozni ambulance Fialova sro
Prague, 106 00, Czechia
Dermamedest sro
Prague, 120 00, Czechia
CCR Prague sro
Prague, 130 00, Czechia
Praglandia sro
Prague, 150 00, Czechia
Dermatologicka ambulance MUDr Petr Trestik
Svitavy, 568 02, Czechia
Gentofte Hospital
Hellerup, 2900, Denmark
Odense University Hospital
Odense, 5000, Denmark
North Estonia Medical Centre
Tallinn, 13419, Estonia
Clinical Research Centre
Tartu, 50106, Estonia
CRST Helsinki
Helsinki, 00180, Finland
CRST Turku
Helsinki, 00180, Finland
Oulun Yliopistollinen sairaala (OYS)
Oulu, 90029, Finland
Terveystalo Tampere
Tampere, 33100, Finland
Fachklinik Bad Bentheim
Bad Bentheim, 48455, Germany
Hautzentrum Friedrichshain - Dermatologie
Berlin, 10247, Germany
Clinical Research Services Berlin GmbH
Berlin, 13672, Germany
Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
Halle, 06120, Germany
Dermatologikum Hamburg
Hamburg, 20354, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Velocity Clinical Research
Leipzig, 04103, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
KliFOs Klinische Forschung Osnabrueck
Osnabrück, 49074, Germany
Hautarztpraxis Mortazawi
Remscheid, 42897, Germany
Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
Miyata Dermatology Clinic
Matsudo-shi, Chiba, 271-0092, Japan
International University of Health and Welfare Narita Hospital
Narita-shi, Chiba, 286-8520, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara-shi, Kanagawa, 252-0392, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Osaka Habikino Medical Center
Habikino-shi, Osaka, 583-8588, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Mita Dermatology Clinic
Minato-ku, Tokyo, 108-0014, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, 161-8521, Japan
Sugamo Kobayashi Derma Clinic
Toshima-ku, Tokyo, 170-0002, Japan
Shirasaki Dermatology Clinic
Takaoka-shi, Toyama, 933-0871, Japan
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia, Michoacán, 58249, Mexico
Scientia Investigacion Clinica Sc
Chihuahua City, 31203, Mexico
Phylasis Clínicas Research S. De R. L. De C. V.
Cuautitlán Izcalli, 54750, Mexico
ClinicMed Daniluk Nowak Spolka komandytowa
Bialystok, 15-879, Poland
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Centermed krakow sp zoo
Krakow, 31-530, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338, Poland
AppleTreeClinics Network Spzoo
Lodz, 90-349, Poland
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, 91-495, Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, 20-078, Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 61-731, Poland
Evimed sp zoo centrum medyczne evimed
Warsaw, 02-625, Poland
Hospital Garcia de Orta, EPE
Almada, 2801-951, Portugal
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3000-075, Portugal
Hospital Cuf Descobertas
Lisbon, 1998-018, Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
Porto, 4200-319, Portugal
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Ryexo Clinical Research
Centurion, Gauteng, 0157, South Africa
About Allergy
Johannesburg, Gauteng, 2057, South Africa
Hiway Medical Centre
Durban, 3630, South Africa
Korea University Ansan Hospital
Ansansi, Gyeonggido, 15355, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
The Catholic University of Korea Incheon St Marys Hospital
Incheon, 21431, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
National Medical Center
Seoul, 04564, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic Univ of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Ewha Womans University Seoul Hospital
Seoul, 07804, South Korea
Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499, South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, 03010, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Valencia, 46015, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, 35620, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, 38030, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380, Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, 54050, Turkey (Türkiye)
Lakeside Healthcare
Corby, NN17 2UR, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (2)
Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
PMID: 41314226DERIVEDGuttman-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.
PMID: 40012373DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 15, 2022
Study Start
December 14, 2022
Primary Completion
June 5, 2024
Study Completion
August 27, 2024
Last Updated
April 3, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.