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COMPLETED
NCT05724199
PHASE3

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). * evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI 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) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

746

Start Date

2023-02-21

Completion Date

2024-12-04

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

Rocatinlimab

Subcutaneous (SC) injection

OTHER

Placebo

SC injection

Locations (234)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

Southwest Skin Specialists

Phoenix, Arizona, United States

US Dermatology Partners Sun City West

Sun City West, Arizona, United States

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Kern Research Inc

Bakersfield, California, United States

Keck Medicine of University of Southern California

Los Angeles, California, United States

Wallace Medical Group Inc

Los Angeles, California, United States

Antelope Valley Clinical Trials

Palmdale, California, United States

University of California at Davis Medical Center

Sacramento, California, United States

Kaiser Permanente South Sacramento Medical Center

Sacramento, California, United States

Acclaim Clinical Research

San Diego, California, United States

Kaiser Permanente Medical Center - Oakland

San Francisco, California, United States

Kaiser Permanente Medical Center - San Francisco

San Francisco, California, United States

Synergy Dermatology

San Francisco, California, United States

TrueBlue Clinical Research

Tampa, Florida, United States

Olympian Clinical Research - Tampa

Tampa, Florida, United States

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, United States

Divine Dermatology and Aesthetics

Atlanta, Georgia, United States

NorthShore University HealthSystem

Skokie, Illinois, United States

DS Research

Clarksville, Indiana, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Dermatology and Skin Cancer Center Leawood

Leawood, Kansas, United States

Industrial Medicine Associates Clinical Research Advanced Dermatology Care

Monroe, Louisiana, United States

Aesthetic and Dermatology Center

Rockville, Maryland, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Oakland Hills Dermatology

Auburn Hills, Michigan, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

Skin Specialists PC

Omaha, Nebraska, United States

Vivida Dermatology

Las Vegas, Nevada, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Schweiger Dermatology Group, PC Research Division

Hackensack, New Jersey, United States

Albuquerque Clinical Trials Incorporated

Albuquerque, New Mexico, United States

Chear Center LLC

The Bronx, New York, United States

Accellacare of Wilmington

Wilmington, North Carolina, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Velocity Clinical Research Inc

Medford, Oregon, United States

Paddington Testing Company Inc

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

US Dermatology Partners Jollyville

Austin, Texas, United States

Newco 3A Research LLC

El Paso, Texas, United States

Sante Clinical Research

Kerrville, Texas, United States

Texas Dermatology Research Center

Plano, Texas, United States

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Framingham Centro Medico

La Plata, Buenos Aires, Argentina

Dim Clinica Privada

Ramos Mejía, Buenos Aires, Argentina

Buenos Aires Skin SA

Buenos Aires, Distrito Federal, Argentina

Fundacion Cidea

Buenos Aires, Distrito Federal, Argentina

Care- Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, Argentina

Psoriahue Medicina Interdisciplinaria SRL

Buenos Aires, Distrito Federal, Argentina

Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

Rosario, Santa Fe Province, Argentina

Emeritus Research Sydney

Botany, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

The Skin Centre

Benowa, Queensland, Australia

Princess Alexandra Hospital

South Brisbane, Queensland, Australia

Veracity Clinical Research

Woolloongabba, Queensland, Australia

Emeritus Research Melbourne

Camberwell, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Klinik Landstrasse

Vienna, Austria

Klinik Hietzing

Vienna, Austria

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende

Bruges, Belgium

Centre Hospitalier Universitaire Brugmann

Brussels, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Clinique Andre Renard

Herstal, Belgium

Dermatologie Handelskaai

Kortrijk, Belgium

Universitaire Ziekenhuizen Leuven Gasthuisberg

Leuven, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Grand Hopital de Charleroi

Loverval, Belgium

Medical Center Asklepii OOD

Dupnitsa, Bulgaria

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

Medical Center Excelsior OOD

Sofia, Bulgaria

Diagnostic-Consultative Center Alexandrovska EOOD

Sofia, Bulgaria

Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD

Sofia, Bulgaria

Dermatology Research Institute Incorporated

Calgary, Alberta, Canada

Laser Rejuvenation Clinics Edmonton D T Incorporated

Edmonton, Alberta, Canada

Alberta Derma Surgery Centre

Edmonton, Alberta, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Wiseman Dermatology Research Incorporated

Winnipeg, Manitoba, Canada

SKiN Health

Coburg, Ontario, Canada

Centricity Research London

London, Ontario, Canada

Dr SK Siddha Medicine Professional Corporation

Newmarket, Ontario, Canada

Allergy Research Canada Incorporated

Niagara Falls, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

Dermatology Ottawa Research Centre

Ottawa, Ontario, Canada

JRB Research Incorporated

Ottawa, Ontario, Canada

The Centre for Dermatology

Richmond Hill, Ontario, Canada

North York Research Incorporated

Toronto, Ontario, Canada

Toronto Research Centre Inc

Toronto, Ontario, Canada

Alliance Clinical Trials

Waterloo, Ontario, Canada

Clinique de Dermatologie Rosemont

Montreal, Quebec, Canada

Innovaderm Research Inc

Montreal, Quebec, Canada

DIEX Recherche Quebec

Québec, Quebec, Canada

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital ,Sun-Yat Sen University

Guangzhou, Guangdong, China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, China

The Fist Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, China

Nanyang First Peoples Hospital

Nanyang, Henan, China

Union Hospital Tongji Medical College Huazhong University of science and Technology

Wuhan, Hubei, China

Wuxi Second Peoples Hospital

Wuxi, Jiangsu, China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Chengdu Second Peoples Hospital

Chengdu, Sichuan, China

the First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliation Hospital Of Ningbo University

Ningbo, Zhejiang, China

Taizhou Central Hospital

Taizhou, Zhejiang, China

Peking University Peoples Hospital

Beijing, China

Shanghai Skin Disease Hospital

Shanghai, China

Hopital Prive d Antony

Antony, France

Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André

Bordeaux, France

Centre Hospitalier Regional Universitaire Brest Hopital Morvan

Brest, France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille, France

Centre Hospitalier de Bretagne Sud - Hopital du Scorff

Lorient, France

Hôpital La Timone

Marseille, France

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, France

Centre Hospitalier Universitaire de Nantes Hôtel Dieu

Nantes, France

Centre Hospitalier Universitaire Archet 2

Nice, France

Hopital Bichat Claude Bernard

Paris, France

Hopital Tenon

Paris, France

Hopital Saint Louis

Paris, France

Polyclinique de Courlancy

Reims, France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, France

Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

Rouen, France

Centre Hospitalier Universitaire Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, France

Hopital d instruction des armees sainte anne

Toulon, France

Universitaetsklinikum Frankfurt

Frankfurt am Main, Germany

Universitaetsmedizin Goettingen - Georg-August-Universitaet

Göttingen, Germany

TFS Trial Form Support GmbH

Hamburg, Germany

MensingDerma research GmbH

Hamburg, Germany

Hautaerzte Zentrum Hannover

Hanover, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitaetsmedizin Mainz

Mainz, Germany

Beldio Research GmbH

Memmingen, Germany

Hautmedizin Saar

Merzing, Germany

Klinikum rechts der Isar der TUM

München, Germany

401 General Military Hospital Of Athens

Athens, Greece

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

General Hospital Of Nea Ionia Konstantopouleio Patision

Nea Ionia, Greece

Geniko Nosokomeio Peiraia Tzaneio

Piraeus, Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Trial Pharma Kft

Békéscsaba, Hungary

Csalogany Orvosi Kozpont

Budapest, Hungary

Clinexpert Kft

Budapest, Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Gyongyosi Bugat Pal Korhaz

Gyöngyös, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

DermaMed Research Kft

Orosháza, Hungary

Allergo-Derm Bakos Kft

Szolnok, Hungary

Obudai Egeszsegugyi Centrum Kft

Zalaegerszeg, Hungary

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Ospedale San Salvatore

LAquila, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

IRCCS Istituto Clinico Humanitas

Rozzano MI, Italy

Fukui Dermatology Clinic

Nagoya, Aichi-ken, Japan

Ekihigashi Dermatology Allergy Clinic

Fukuoka, Fukuoka, Japan

Takagi Dermatological Clinic Branch

Obihiro-shi, Hokkaido, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Katahira Dermatology Urology Clinic

Kagoshima, Kagoshima-ken, Japan

Kosugi Dermatology Clinic

Kawasaki-shi, Kanagawa, Japan

Nomura Dermatology Clinic

Yokohama, Kanagawa, Japan

Jouzan Hihuka Hinyoukika Clinic

Kumamoto, Kumamoto, Japan

Suizenji Dermatology Clinic

Kumamoto, Kumamoto, Japan

Yoshioka Dermatology Clinic

Neyagawa, Osaka, Japan

JA Shizuoka Kohseiren Enshu Hospital

Hamamatsu, Shizuoka, Japan

Mildix Skin Clinic

Adachi-ku, Tokyo, Japan

Naoko Dermatology Clinic

Setagaya-ku, Tokyo, Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Yamate Dermatology Clinic

Shinjuku-ku, Tokyo, Japan

Hospital Sultan Ismail

Johor Bahru, Johor, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Queen Elizabeth Hospital

Kota Kinabalu, Sabah, Malaysia

Bravis Ziekenhuis

Bergen op Zoom, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Dermapolis Medical Dermatology Center dr n med Edyta Gebska

Chorzów, Poland

GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

Katowice, Poland

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna

Krakow, Poland

AppleTreeClinics Network Spzoo

Lodz, Poland

Ip Clinic Sp zoo

Lodz, Poland

Twoja Przychodnia Scm

Szczecin, Poland

DermMedica Spzoo Centrum Columbus

Wroclaw, Poland

Doctor Samuel Sanchez PSC

Caguas, Puerto Rico

Theramed Healthcare SRL

Brasov, Romania

Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

Cluj-Napoca, Romania

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

National Skin Centre

Singapore, Singapore

Maxderm, sro

Bardejov, Slovakia

Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto

Bratislava, Slovakia

Fakultna nemocnica s poliklinikou JA Reimana Presov

Prešov, Slovakia

Sanare spol sro

Svidník, Slovakia

Univerzitetni klinicni center Ljubljana

Ljubljana, Slovenia

Univerzitetni Klinicni Center Maribor

Maribor, Slovenia

Hospital Universitario Basurto

Bilbao, Basque Country, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Inselspital Bern

Bern, Switzerland

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Acibadem Altunizade Hastanesi

Istanbul, Turkey (Türkiye)

Marmara Universitesi Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey (Türkiye)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Russells Hall Hospital

Dudley, United Kingdom

West Middlesex University Hospital

Isleworth, United Kingdom

The Royal Free Hospital

London, United Kingdom

Salford Care Organisation

Salford, United Kingdom

Accellacare Yorkshire

Shipley, United Kingdom