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COMPLETED
NCT05651711
PHASE3

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Sponsor: Amgen

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

726

Start Date

2022-12-14

Completion Date

2024-08-27

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DRUG

Rocatinlimab

Rocatinlimab will be administered through a subcutaneous (SC) injection.

OTHER

Placebo

The matching placebo will be administered through a SC injection.

Locations (197)

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