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)

Status: Completed
Location: See all (188) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Clinical Trials Institute of Northwest Arkansas
Fayetteville
Burke Pharmaceutical Research
Hot Springs
Arizona
Research Solutions of Arizona, PC
Litchfield Park
Center for Dermatology and Plastic Surgery
Scottsdale
California
Velocity Clinical Research Chula Vista
Chula Vista
West Coast Research LLC
Dublin
California Dermatology and Clinical Research Institute
Encinitas
Center for Dermatology Clinical Research Inc
Fremont
Velocity Clinical Research - San Diego
La Mesa
Velocity Clinical Research - North Hollywood
North Hollywood
Cura Clinical Research
Palmdale
University of California at San Francisco, Dermatology Clinic at Mount Zion
San Francisco
Clinical Science Institute
Santa Monica
Colorado
Clarity Dermatology
Castle Rock
Velocity Clinical Research - Denver
Denver
Washington, D.c.
Foxhall Research Center
Washington D.c.
Florida
Renaissance Research and Medical Group
Cape Coral
Driven Research LLC
Coral Gables
Saint Jude Clinical Research
Doral
Direct Helpers Research Center
Hialeah
Glick Skin Institute
Margate
Miami Dade Medical Research Institute, LLC
Miami
Innovation Medical Research Center Inc
Palmetto Bay
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa
Georgia
Advanced Medical Research PC
Sandy Springs
Illinois
Sneeze, Wheeze, and Itch Associates, LLC
Normal
Indiana
The South Bend Clinic LLP
South Bend
Options Research Group LLC
West Lafayette
Kansas
Dermatology and Skin Cancer Center of Overland Park
Overland Park
Kentucky
DS Research
Louisville
Kentucky Advanced Medical Research LLC
Murray
Massachusetts
MetroBoston Clinical Partners
Brighton
Michigan
Wendy Sadoff MD Dermatology PC
Farmington Hills
Revival Research Institute LLC
Troy
Somerset Skin Centre
Troy
North Carolina
Duke South Durham
Durham
Nebraska
Advanced Dermatology of the Midlands
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New Jersey
Weiss Medical
Riverdale
Nevada
James Del Rosso Dermatology Research
Las Vegas
Skin Cancer and Dermatology Institute
Reno
New York
Corning Center For Clinical Research
Horseheads
Forest Hills Dermatology Group
Kew Gardens
Crystal Run Healthcare
Monroe
Ace Clinical Trials
New York
Icahn School of Medicine at Mount Sinai
New York
OptiSkin Medical
New York
Montefiore Medical Center
The Bronx
Ohio
Bernstein Clinical Research Center LLC
Cincinnati
University of Cincinnati
Cincinnati
The Ohio State University Dermatology East
Gahanna
Oregon
Velocity Clinical Research - Grants Pass
Grants Pass
Oregon Medical Research Center
Portland
Rhode Island
Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
Warwick
Texas
Bellaire Dermatology Associates
Bellaire
US Dermatology Partners Cedar Park
Cedar Park
Alina Clinical Trials, LLC
Dallas
Zenos Clinical Research, LLC
Dallas
MedCare Pharma - Houston
Houston
The University of Texas Health Science Center at Houston
Houston
FMCScience LLC
Lampasas
Epic Clinical Research Incorporated
Lewisville
Sienna Dermatology Research
Missouri City
Andante Research
San Antonio
Dermatology Clinical Research Center of San Antonio
San Antonio
Texas Dermatology and Laser Specialists
San Antonio
Utah
University of Utah MidValley Dermatology
Murray
Virginia
Eastern Virginia Medical School
Norfolk
Washington
MultiCare Institute for Research and Innovation
Spokane
Other Locations
Australia
Box Hill Hospital
Box Hill
Skin Health Institute
Carlton
St George Dermatology and Skin Cancer Centre
Darlinghurst
Sinclair Dermatology
East Melbourne
Premier Specialists
Kogarah
The Alfred Hospital
Melbourne
The Royal Melbourne Hospital
Parkville
Belgium
Hopital Erasme
Brussels
Clinique Andre Renard
Herstal
Dermatologie Maldegem
Maldegem
Brazil
CETI - Centro de Estudo em Terapias Inovadoras
Curitiba
Centro Multidisciplinar de Estudos Clinicos - CEMEC
São Bernardo Do Campo
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José Dos Campos
Canada
Beacon Dermatology
Calgary
Kingsway Clinical Research
Etobicoke
Lynderm Research Inc
Markham
The Centre for Clinical Trials Inc
Oakville
SKiN Centre for Dermatology
Peterborough
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec
The Centre for Dermatology
Richmond Hill
Clinique Dermatologique de Sherbrooke
Sherbrooke
Doctor Chih-Ho Hong Medical Incorporated
Surrey
Research Toronto
Toronto
XLR8 Medical Research, Incorporated
Windsor
Denmark
Gentofte Hospital
Hellerup
Odense University Hospital
Odense
Estonia
North Estonia Medical Centre
Tallinn
Clinical Research Centre
Tartu
Finland
CRST Helsinki
Helsinki
CRST Turku
Helsinki
Oulun Yliopistollinen sairaala (OYS)
Oulu
Terveystalo Tampere
Tampere
Germany
Fachklinik Bad Bentheim
Bad Bentheim
Clinical Research Services Berlin GmbH
Berlin
Hautzentrum Friedrichshain - Dermatologie
Berlin
Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
Halle
Dermatologikum Hamburg
Hamburg
Universitaetsklinikum Schleswig-Holstein
Kiel
Velocity Clinical Research
Leipzig
Universitaetsklinikum Muenster
Münster
KliFOs Klinische Forschung Osnabrueck
Osnabrück
Hautarztpraxis Mortazawi
Remscheid
Helios Klinikum Wuppertal
Wuppertal
Japan
Osaka Habikino Medical Center
Habikino-shi
Hamamatsu University Hospital
Hamamatsu
St Marianna University Hospital
Kawasaki-shi
Kobe University Hospital
Kobe
Miyata Dermatology Clinic
Matsudo-shi
Mita Dermatology Clinic
Minato-ku
Nagasaki University Hospital
Nagasaki
International University of Health and Welfare Narita Hospital
Narita-shi
National Hospital Organization Sagamihara National Hospital
Sagamihara-shi
Dermatology and Ophthalmology Kume Clinic
Sakai-shi
Showa University Hospital
Shinagawa-ku
Seibo International Catholic Hospital
Shinjuku-ku
Shirasaki Dermatology Clinic
Takaoka-shi
Sugamo Kobayashi Derma Clinic
Toshima-ku
Showa University Northern Yokohama Hospital
Yokohama
Mexico
Scientia Investigacion Clinica Sc
Chihuahua City
Phylasis Clínicas Research S. De R. L. De C. V.
Cuautitlán Izcalli
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia
Poland
ClinicMed Daniluk Nowak Spolka komandytowa
Bialystok
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
Chorzów
Uniwersyteckie Centrum Kliniczne
Gdansk
Centermed krakow sp zoo
Krakow
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz
AppleTreeClinics Network Spzoo
Lodz
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan
Evimed sp zoo centrum medyczne evimed
Warsaw
Portugal
Hospital Garcia de Orta, EPE
Almada
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra
Hospital Cuf Descobertas
Lisbon
Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
Porto
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Porto
Republic of Korea
Korea University Ansan Hospital
Ansansi, Gyeonggido
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do
Pusan National University Hospital
Busan
Kyungpook National University Hospital
Daegu
Chosun University Hospital
Gwangju
Inha University Hospital
Incheon
The Catholic University of Korea Incheon St Marys Hospital
Incheon
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Ewha Womans University Seoul Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Konkuk University Medical Center
Seoul
Korea University Anam Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
National Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic Univ of Korea Seoul St Marys Hospital
Seoul
Ajou University Hospital
Suwon-si, Gyeonggi-do
Romania
Spitalul Clinic Colentina
Bucharest
South Africa
Ryexo Clinical Research
Centurion
Hiway Medical Centre
Durban
About Allergy
Johannesburg
Spain
Hospital General Universitario de Alicante
Alicante
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Hospital de Manises
Manises
Clinica Universidad de Navarra
Pamplona
Hospital Universitario Virgen Macarena
Seville
Hospital Arnau de Vilanova de Valencia
Valencia
Sweden
Karolinska Universitetssjukhuset Solna
Stockholm
Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep
Bezmialem Vakif Universitesi Hastanesi
Istanbul
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli
Sakarya Egitim ve Arastirma Hastanesi
Sakarya
United Kingdom
Lakeside Healthcare
Corby
Guys Hospital
London
Southampton General Hospital
Southampton
Time Frame
Start Date: 2022-12-14
Completion Date: 2024-08-27
Participants
Target number of participants: 726
Treatments
Experimental: Rocatinlimab
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.
Placebo_comparator: Placebo
Placebo Q4W for 24 weeks with a loading dose at Week 2.
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov