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COMPLETED
NCT05398445
PHASE3

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Official title: A Phase 3, 24-week, Randomized, 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

769

Start Date

2022-05-31

Completion Date

2025-01-13

Last Updated

2026-07-23

Healthy Volunteers

No

Interventions

DRUG

Rocatinlimab

Participants will receive Rocatinlimab subcutaneously.

DRUG

Placebo

Participants will receive a placebo subcutaneously.

Locations (202)

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

First OC Dermatology

Fountain Valley, California, United States

Kaiser Permanente - Glendale Medical Center

Glendale, California, United States

Long Beach Research Institute

Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Skin Care Research Incorporated

Boca Raton, Florida, United States

Palm Beach Dermatology Group

Delray Beach, Florida, United States

Global Research Associates

Homestead, Florida, United States

Healthy Life Research

Miami, Florida, United States

Savin Medical Group LLC

Miami Lakes, Florida, United States

Kirsch Dermatology LLC

Naples, Florida, United States

Pure Skin Dermatology and Aesthetics

Orlando, Florida, United States

Industrial Medicine Associates Ima Clinical Research Inc

St. Petersburg, Florida, United States

Genesis Clinical Research LLC

Tampa, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

DeNova Research

Chicago, Illinois, United States

Dundee Dermatology

West Dundee, Illinois, United States

The Indiana Clinical Trials Center PC

Plainfield, Indiana, United States

Institute for Asthma and Allergy

Chevy Chase, Maryland, United States

Continental Clinical Solutions, LLC

Towson, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

Onyx Clinical Research

Flint, Michigan, United States

Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, United States

Jubilee Clinical Research Inc

Las Vegas, Nevada, United States

Allcutis Research, Llc - Portsmouth

Portsmouth, New Hampshire, United States

Continental Clinical Solutions - Cherry Hill

Cherry Hill, New Jersey, United States

Industrial Medicine Associates Ima Clinical Research Inc

Hartsdale, New York, United States

Sadick Research Group

New York, New York, United States

Dermatology Specialists of Charlotte

Charlotte, North Carolina, United States

Onsite Clinical Solutions

Charlotte, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, United States

Optima Research

Boardman, Ohio, United States

ClinOhio Research Services

Columbus, Ohio, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, United States

Essential Medical Research LLC

Tulsa, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

DermDox Dermatology, LLC

Sugarloaf, Pennsylvania, United States

Cumberland Skin Center

Hermitage, Tennessee, United States

Dermatology Treatment and Research Center PA

Dallas, Texas, United States

The Woodlands Dermatology Associates

The Woodlands, Texas, United States

Education and Research Foundation Inc

Lynchburg, Virginia, United States

Frontier Derm Partners

Mill Creek, Washington, United States

West Virginia Research Institute

Morgantown, West Virginia, United States

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Derqui, Pilar, Buenos Aires, Argentina

Centro Dermatológico Schejtman

San Miguel, Buenos Aires, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, Argentina

Conexa Investigacion Clinica SA

CABA, Distrito Federal, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Instituto de Diagnostico Abc American British Cowdray

Rosario, Santa Fe Province, Argentina

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Upeclin-Pesq Clin FacMed Botucatu

Botucatu, São Paulo, Brazil

Hosp e Maternidade Dr Christovao da Gama

Santo André, São Paulo, Brazil

Fundacao Abc - Centro Univ Fmabc

Santo André, São Paulo, Brazil

Consultoria Medica e Pesquisa Clinica Cmpc

Sorocaba, São Paulo, Brazil

IBPClin Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, Brazil

Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

São Paulo, Brazil

Alberta Derma Surgery Centre

Edmonton, Alberta, Canada

Vida Clinical Research

Edmonton, Alberta, Canada

CCA Medical Research Corporation

Ajax, Ontario, Canada

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

LEADER Research

Hamilton, Ontario, Canada

DermEdge Research Incorporated

Mississauga, Ontario, Canada

Canadian Dermatology Centre

North York, Ontario, Canada

Gordon Sussman Clinical Research Incorporated

North York, Ontario, Canada

Oak Ridges Aesthetics Centre

Richmond Hill, Ontario, Canada

Innovaderm Research Inc

Montreal, Quebec, Canada

Recherche Clinique Sigma Incorporated

Québec, Quebec, Canada

Skinsense Medical Research

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 First Hospital Of Hebei Medical University

Shijiazhuang, Hebei, China

Nanyang First Peoples Hospital

Nanyang, Henan, China

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Union Hospital Tongji Medical College Huazhong University of science and Technology

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, Jiangsu, China

Wuxi Peoples Hospital

Wuxi, Jiangsu, China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Chengdu Second Peoples Hospital

Chengdu, Sichuan, China

the First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, China

Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Taizhou Central Hospital

Taizhou, Zhejiang, China

And 102 more locations on ClinicalTrials.gov