A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
NCT ID: NCT05651711
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
726 participants
INTERVENTIONAL
2022-12-14
2024-08-27
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rocatinlimab
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Rocatinlimab
Rocatinlimab will be administered through a subcutaneous (SC) injection.
Placebo
Placebo Q4W for 24 weeks with a loading dose at Week 2.
Placebo
The matching placebo will be administered through a SC injection.
Interventions
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Rocatinlimab
Rocatinlimab will be administered through a subcutaneous (SC) injection.
Placebo
The matching placebo will be administered through a SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Solutions of Arizona, PC
Litchfield Park, Arizona, United States
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, United States
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Velocity Clinical Research Chula Vista
Chula Vista, California, United States
West Coast Research LLC
Dublin, California, United States
California Dermatology and Clinical Research Institute
Encinitas, California, United States
Center for Dermatology Clinical Research Inc
Fremont, California, United States
Velocity Clinical Research - San Diego
La Mesa, California, United States
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States
Cura Clinical Research
Palmdale, California, United States
University of California at San Francisco, Dermatology Clinic at Mount Zion
San Francisco, California, United States
Clinical Science Institute
Santa Monica, California, United States
Clarity Dermatology
Castle Rock, Colorado, United States
Velocity Clinical Research - Denver
Denver, Colorado, United States
Foxhall Research Center
Washington D.C., District of Columbia, United States
Renaissance Research and Medical Group
Cape Coral, Florida, United States
Driven Research LLC
Coral Gables, Florida, United States
Saint Jude Clinical Research
Doral, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Glick Skin Institute
Margate, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
Innovation Medical Research Center Inc
Palmetto Bay, Florida, United States
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Sneeze, Wheeze, and Itch Associates, LLC
Normal, Illinois, United States
The South Bend Clinic LLP
South Bend, Indiana, United States
Options Research Group LLC
West Lafayette, Indiana, United States
Dermatology and Skin Cancer Center of Overland Park
Overland Park, Kansas, United States
DS Research
Louisville, Kentucky, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States
MetroBoston Clinical Partners
Brighton, Massachusetts, United States
Wendy Sadoff MD Dermatology PC
Farmington Hills, Michigan, United States
Revival Research Institute LLC
Troy, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Advanced Dermatology of the Midlands
Omaha, Nebraska, United States
James Del Rosso Dermatology Research
Las Vegas, Nevada, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Weiss Medical
Riverdale, New Jersey, United States
Corning Center For Clinical Research
Horseheads, New York, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Crystal Run Healthcare
Monroe, New York, United States
Ace Clinical Trials
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
OptiSkin Medical
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke South Durham
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, United States
The Ohio State University Dermatology East
Gahanna, Ohio, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, United States
Oregon Medical Research Center
Portland, Oregon, United States
Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
Warwick, Rhode Island, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
US Dermatology Partners Cedar Park
Cedar Park, Texas, United States
Alina Clinical Trials, LLC
Dallas, Texas, United States
Zenos Clinical Research, LLC
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
MedCare Pharma - Houston
Houston, Texas, United States
FMCScience LLC
Lampasas, Texas, United States
Epic Clinical Research Incorporated
Lewisville, Texas, United States
Sienna Dermatology Research
Missouri City, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Andante Research
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
University of Utah MidValley Dermatology
Murray, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
MultiCare Institute for Research and Innovation
Spokane, Washington, United States
St George Dermatology and Skin Cancer Centre
Darlinghurst, New South Wales, Australia
Premier Specialists
Kogarah, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Skin Health Institute
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Hopital Erasme
Brussels, , Belgium
Clinique Andre Renard
Herstal, , Belgium
Dermatologie Maldegem
Maldegem, , Belgium
CETI - Centro de Estudo em Terapias Inovadoras
Curitiba, Paraná, Brazil
Centro Multidisciplinar de Estudos Clinicos - CEMEC
São Bernardo do Campo, São Paulo, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, Brazil
Beacon Dermatology
Calgary, Alberta, Canada
Doctor Chih-Ho Hong Medical Incorporated
Surrey, British Columbia, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
The Centre for Clinical Trials Inc
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
XLR8 Medical Research, Incorporated
Windsor, Ontario, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, Canada
Clinique Dermatologique de Sherbrooke
Sherbrooke, Quebec, Canada
Kozni ambulance Kutna Hora sro
Kutná Hora, , Czechia
Nemocnice Novy Jicin as
Nový Jičín, , Czechia
CCR Czech as
Pardubice, , Czechia
Fakultni nemocnice Plzen
Pilsen, , Czechia
Kozni ambulance Fialova sro
Prague, , Czechia
Dermamedest sro
Prague, , Czechia
CCR Prague sro
Prague, , Czechia
Praglandia sro
Prague, , Czechia
Dermatologicka ambulance MUDr Petr Trestik
Svitavy, , Czechia
Gentofte Hospital
Hellerup, , Denmark
Odense University Hospital
Odense, , Denmark
North Estonia Medical Centre
Tallinn, , Estonia
Clinical Research Centre
Tartu, , Estonia
CRST Helsinki
Helsinki, , Finland
CRST Turku
Helsinki, , Finland
Oulun Yliopistollinen sairaala (OYS)
Oulu, , Finland
Terveystalo Tampere
Tampere, , Finland
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Hautzentrum Friedrichshain - Dermatologie
Berlin, , Germany
Clinical Research Services Berlin GmbH
Berlin, , Germany
Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
Halle, , Germany
Dermatologikum Hamburg
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Velocity Clinical Research
Leipzig, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
KliFOs Klinische Forschung Osnabrueck
Osnabrück, , Germany
Hautarztpraxis Mortazawi
Remscheid, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Miyata Dermatology Clinic
Matsudo-shi, Chiba, Japan
International University of Health and Welfare Narita Hospital
Narita-shi, Chiba, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara-shi, Kanagawa, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Osaka Habikino Medical Center
Habikino-shi, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Mita Dermatology Clinic
Minato-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, Japan
Sugamo Kobayashi Derma Clinic
Toshima-ku, Tokyo, Japan
Shirasaki Dermatology Clinic
Takaoka-shi, Toyama, Japan
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia, Michoacán, Mexico
Scientia Investigacion Clinica Sc
Chihuahua City, , Mexico
Phylasis Clínicas Research S. De R. L. De C. V.
Cuautitlán Izcalli, , Mexico
ClinicMed Daniluk Nowak Spolka komandytowa
Bialystok, , Poland
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
Chorzów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centermed krakow sp zoo
Krakow, , Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, , Poland
AppleTreeClinics Network Spzoo
Lodz, , Poland
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, , Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, , Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, , Poland
Evimed sp zoo centrum medyczne evimed
Warsaw, , Poland
Hospital Garcia de Orta, EPE
Almada, , Portugal
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, , Portugal
Hospital Cuf Descobertas
Lisbon, , Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Porto, , Portugal
Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
Porto, , Portugal
Spitalul Clinic Colentina
Bucharest, , Romania
Ryexo Clinical Research
Centurion, Gauteng, South Africa
About Allergy
Johannesburg, Gauteng, South Africa
Hiway Medical Centre
Durban, , South Africa
Korea University Ansan Hospital
Ansansi, Gyeonggido, , South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chosun University Hospital
Gwangju, , South Korea
The Catholic University of Korea Incheon St Marys Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic Univ of Korea Seoul St Marys Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon-si, Gyeonggi-do, , South Korea
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Valencia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Hastanesi
Istanbul, , Turkey (Türkiye)
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, , Turkey (Türkiye)
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, , Turkey (Türkiye)
Lakeside Healthcare
Corby, , United Kingdom
Guys Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-501538-44
Identifier Type: OTHER
Identifier Source: secondary_id
20210143
Identifier Type: -
Identifier Source: org_study_id
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