ACTIVE_NOT_RECRUITING

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

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Conditions

Atopic DermatitisRocatinlimabAMG 451Eczema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

Official Title

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Quick Facts

Study Start:2023-05-31
Study Completion:2027-06-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05882877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
  2. * Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).
  1. * Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006
United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, 85032
United States
Affiliated Dermatology
Scottsdale, Arizona, 85255
United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Dermatology Trial Associates
Bryant, Arkansas, 72022
United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
United States
Kern Research Inc
Bakersfield, California, 93301
United States
Hope Clinical Research LLC
Canoga Park, California, 91303
United States
West Coast Research LLC
Dublin, California, 94568
United States
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
United States
First OC Dermatology
Fountain Valley, California, 92708
United States
Antelope Valley Clinical Trials
Lancaster, California, 93534
United States
Chemidox Clinical Trials Incorporated
Lancaster, California, 93534
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
University of California Los Angeles
Los Angeles, California, 90024
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Wallace Medical Group Inc
Los Angeles, California, 90056
United States
Northridge Clinical Trials
Northridge, California, 91325
United States
University of California Irvine
Orange, California, 92868
United States
Havana Research Institute Inc
Pasadena, California, 91105
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
University of California at Davis Medical Center
Sacramento, California, 95816
United States
Kaiser Permanente South Sacramento Medical Center
Sacramento, California, 95823
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Kaiser Permanente Medical Center - Oakland
San Francisco, California, 94118
United States
Kaiser Permanente Medical Center - San Francisco
San Francisco, California, 94118
United States
Wolverine Clinical Trials
Santa Ana, California, 92706
United States
Clinical Science Institute
Santa Monica, California, 90404
United States
IMMUNOe Research Centers
Centennial, Colorado, 80112
United States
Skin Care Research Incorporated
Boca Raton, Florida, 33486
United States
Renaissance Research and Medical Group
Cape Coral, Florida, 33991
United States
Driven Research LLC
Coral Gables, Florida, 33134
United States
Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, 33071
United States
D and H Doral Research Centers
Doral, Florida, 33122
United States
Saint Jude Clinical Research
Doral, Florida, 33172
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
Global Research Solutions
Homestead, Florida, 33030
United States
Nexus Clinical Research
Homestead, Florida, 33033
United States
Glick Skin Institute
Margate, Florida, 33063
United States
ara Professionals Limited Liability Corporation
Miami, Florida, 33155
United States
Gold Coast Health Research Center
Miami, Florida, 33155
United States
Miami Clinical Research
Miami, Florida, 33155
United States
Healthy Life Research
Miami, Florida, 33175
United States
Anchor Medical Research
Miami, Florida, 33176
United States
Meridian International Research
Miami Gardens, Florida, 33014
United States
Savin Medical Group LLC
Miami Lakes, Florida, 33014
United States
Clinical Associates of Orlando Limited Liability Company
Orlando, Florida, 32819
United States
Innovation Medical Research Center Inc
Palmetto Bay, Florida, 33157
United States
University of South Florida
Tampa, Florida, 33612
United States
Olympian Clinical Research - Tampa
Tampa, Florida, 33615
United States
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, 30022
United States
First Georgia Physicians Group
Fayetteville, Georgia, 30214
United States
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
DeNova Research
Chicago, Illinois, 60602
United States
Sneeze, Wheeze, and Itch Associates, LLC
Normal, Illinois, 61761
United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077
United States
Dundee Dermatology
West Dundee, Illinois, 60118
United States
DS Research
Clarksville, Indiana, 47129
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168
United States
Options Research Group LLC
West Lafayette, Indiana, 47906
United States
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, 66211
United States
DS Research
Louisville, Kentucky, 40241
United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, 42071
United States
Foxhall Research Center
Chevy Chase, Maryland, 20815
United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, 20815
United States
Continental Clinical Solutions, LLC
Towson, Maryland, 21204
United States
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
United States
Onyx Clinical Research
Flint, Michigan, 48532
United States
Revival Research Institute LLC
Troy, Michigan, 48084
United States
Somerset Skin Centre
Troy, Michigan, 48084
United States
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, 64064
United States
Saint Louis University
St Louis, Missouri, 63110
United States
Somnos Clinical Research
Lincoln, Nebraska, 68505
United States
Jubilee Clinical Research Inc
Las Vegas, Nevada, 89106
United States
Excel Clinical Research
Las Vegas, Nevada, 89109
United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
United States
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
United States
Albuquerque Clinical Trials Incorporated
Albuquerque, New Mexico, 87102
United States
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Sadick Research Group
New York, New York, 10075
United States
OptiSkin Medical
New York, New York, 10128
United States
Chear Center LLC
The Bronx, New York, 10455
United States
DJL Clinical Research PLLC
Charlotte, North Carolina, 28211
United States
Wilmington Dermatology Center
Wilmington, North Carolina, 28405
United States
Accellacare of Wilmington
Wilmington, North Carolina, 28411
United States
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, 27103
United States
Bexley Dermatology Research
Bexley, Ohio, 43209
United States
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, 45236
United States
The Ohio State University
Gahanna, Ohio, 43230
United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
United States
Dermatologist of Central States Clinical Research - Springfield
Springfield, Ohio, 45505
United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
United States
Essential Medical Research LLC
Tulsa, Oklahoma, 74145
United States
Velocity Clinical Research Medford
Medford, Oregon, 97504
United States
Oregon Medical Research Center
Portland, Oregon, 97201
United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210
United States
Best Skin Research
Camp Hill, Pennsylvania, 17011
United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Health Concepts
Rapid City, South Dakota, 57702
United States
Cumberland Skin Center
Hermitage, Tennessee, 37076
United States
US Dermatology Partners Jollyville
Austin, Texas, 78759
United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401
United States
US Dermatology Partners Cedar Park
Cedar Park, Texas, 78613
United States
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411
United States
Alina Clinical Trials, LLC
Dallas, Texas, 75225
United States
Dermatology Treatment and Research Center PA
Dallas, Texas, 75230
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
Texas Dermatology Research Center
Dallas, Texas, 75246
United States
Newco 3A Research LLC
El Paso, Texas, 79925
United States
Center For Clinical Studies PLLC
Houston, Texas, 77004
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Sante Clinical Research
Kerrville, Texas, 78028
United States
Long and Harris Dermatology
Lubbock, Texas, 79424
United States
Sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149
United States
Stride Clinical Research LLC
Missouri City, Texas, 77459
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
United States
Stryde Research Epiphany Dermatology
Southlake, Texas, 76092
United States
The Woodlands Dermatology Associates
The Woodlands, Texas, 77380
United States
Tanner Clinic
Murray, Utah, 84107
United States
University of Utah MidValley Dermatology
Murray, Utah, 84107
United States
Education and Research Foundation Inc
Forest, Virginia, 24551
United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
MultiCare Institute for Research and Innovation
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-31
Study Completion Date2027-06-02

Study Record Updates

Study Start Date2023-05-31
Study Completion Date2027-06-02

Terms related to this study

Keywords Provided by Researchers

  • Atopic Dermatitis
  • Rocatinlimab
  • AMG 451
  • Eczema

Additional Relevant MeSH Terms

  • Atopic Dermatitis