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Purpose

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

Condition

Eligibility

Eligible Ages
Between 12 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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. - 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).

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ARM A: Dose 1 to Dose 1 		Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 1 will be randomized or assigned to receive Dose 1 Every 4 Weeks (Q4W) or Every 8 Weeks (Q8W). Participants from parent Rocatinlimab study ROCKET-VOYAGER who received Dose 1 will be assigned to receive Dose 1 Q4W.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
    • KHK4083
Experimental
ARM B: Dose 2 to Dose 2 		Participants from parent Rocatinlimab studies ROCKET-Ignite, ROCKET-SHUTTLE, or ROCKET-ASTRO who received Dose 2 will be randomized or assigned to receive Dose 2 Q4W or Q8W.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
    • KHK4083
Placebo Comparator
ARM C: Dose 1 or Dose 2 to Placebo 		Participants from parent Rocatinlimab studies ROCKET-Ignite or ROCKET-Horizon who received Dose 1 will be randomized to receive placebo Q4W. Participants from parent Rocatinlimab study ROCKET-Ignite who received Dose 2 will be randomized to receive placebo Q4W.
  • Other: Placebo
    SC injection
Placebo Comparator
ARM D: Placebo to Placebo 		Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET-SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received placebo will be randomized or assigned to receive placebo Q4W.
  • Other: Placebo
    SC injection
Experimental
ARM E: Dose 1, Dose 2, Placebo, or Open-label (OL) to OL Dose 1 		Participants from parent Rocatinlimab studies ROCKET- Ignite, ROCKET-Horizon, ROCKET- SHUTTLE, ROCKET-ASTRO, or ROCKET-VOYAGER who received Dose 1, Dose 2, or placebo will be assigned to receive OL Rocatinlimab Dose 1 Q4W. Participants who received OL in parent Rocatinlimab study ROCKET- ASTRO will continue to receive OL Rocatinlimab Dose 1 Q4W. All participants from parent Rocatinlimab study ROCKET-Orbit will be assigned to receive OL Rocatinlimab Dose 1 Q4W.
  • Drug: Rocatinlimab
    Subcutaneous (SC) injection
    Other names:
    • AMG 451
    • KHK4083

Recruiting Locations

Cahaba Dermatology and Skin Health Center
Birmingham, Alabama 35244

Medical Dermatology Specialists
Phoenix, Arizona 85006

Alliance Dermatology and Mohs Center
Phoenix, Arizona 85032

Affiliated Dermatology
Scottsdale, Arizona 85255

Scottsdale Clinical Trials
Scottsdale, Arizona 85260

Dermatology Trial Associates
Bryant, Arkansas 72022

Burke Pharmaceutical Research
Hot Springs, Arkansas 71913

Arkansas Research Trials, LLC
North Little Rock, Arkansas 72117

Kern Research Inc
Bakersfield, California 93301

Hope Clinical Research LLC
Canoga Park, California 91303

West Coast Research LLC
Dublin, California 94568

California Dermatology and Clinical Research Institute
Encinitas, California 92024

First OC Dermatology
Fountain Valley, California 92708

Chemidox Clinical Trials Incorporated
Lancaster, California 93534

Long Beach Research Institute
Long Beach, California 90805

University of California Los Angeles
Los Angeles, California 90024

Dermatology Research Associates
Los Angeles, California 90045

Wallace Medical Group Inc
Los Angeles, California 90056

Northridge Clinical Trials
Northridge, California 91325

Havana Research Institute Inc
Pasadena, California 91105

Integrative Skin Science and Research
Sacramento, California 95815

University of California at Davis Medical Center
Sacramento, California 95816

Kaiser Permanente South Sacramento Medical Center
Sacramento, California 95823

Acclaim Clinical Research
San Diego, California 92120

Kaiser Permanente Medical Center - Oakland
San Francisco, California 94118

Kaiser Permanente Medical Center - San Francisco
San Francisco, California 94118

Clinical Science Institute
Santa Monica, California 90404

Wolverine Clinical Trials
Tustin, California 92780

IMMUNOe Research Centers
Centennial, Colorado 80112

Skin Care Research Incorporated
Boca Raton, Florida 33486

Renaissance Research and Medical Group
Cape Coral, Florida 33991

Driven Research LLC
Coral Gables, Florida 33134

Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida 33071

D and H Doral Research Centers
Doral, Florida 33122

Saint Jude Clinical Research
Doral, Florida 33172

Direct Helpers Research Center
Hialeah, Florida 33012

Nexus Clinical Research
Homestead, Florida 33033

Meridian International Research
Miami Gardens, Florida 33014

Savin Medical Group LLC
Miami Lakes, Florida 33014

Gold Coast Health Research Center
Miami, Florida 33155

Miami Clinical Research
Miami, Florida 33155

Anchor Medical Research
Miami, Florida 33176

Innovation Medical Research Center Inc
Palmetto Bay, Florida 33157

Olympian Clinical Research - Tampa
Tampa, Florida 33615

Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia 30022

First Georgia Physicians Group
Fayetteville, Georgia 30214

Advanced Medical Research PC
Sandy Springs, Georgia 30328

Treasure Valley Medical Research
Boise, Idaho 83706

DeNova Research
Chicago, Illinois 60602

Sneeze, Wheeze, and Itch Associates, LLC
Normal, Illinois 61761

Endeavor Health Clinical Trials Center
Skokie, Illinois 60077

Dundee Dermatology
West Dundee, Illinois 60118

DS Research
Clarksville, Indiana 47129

Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250

Southern Indiana Clinical Trials
New Albany, Indiana 47150

The Indiana Clinical Trials Center PC
Plainfield, Indiana 46168

Options Research Group LLC
West Lafayette, Indiana 47906

Dermatology and Skin Cancer Center Leawood
Leawood, Kansas 66211

DS Research
Louisville, Kentucky 40241

Kentucky Advanced Medical Research LLC
Murray, Kentucky 42071

Foxhall Research Center
Chevy Chase, Maryland 20815

Institute for Asthma and Allergy
Chevy Chase, Maryland 20815

Continental Clinical Solutions, LLC
Towson, Maryland 21204

MetroBoston Clinical Partners
Brighton, Massachusetts 02135

University of Michigan
Ann Arbor, Michigan 48109

Henry Ford Medical Center - New Center One
Detroit, Michigan 48202

Onyx Clinical Research
Flint, Michigan 48532

Revival Research Institute LLC
Troy, Michigan 48084

Somerset Skin Centre
Troy, Michigan 48084

Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri 64064

Saint Louis University
Saint Louis, Missouri 63110

Somnos Clinical Research
Lincoln, Nebraska 68505

Skin Specialists PC
Omaha, Nebraska 68144

Jubilee Clinical Research Inc
Las Vegas, Nevada 89106

Excel Clinical Research
Las Vegas, Nevada 89109

Las Vegas Clinical Trials
North Las Vegas, Nevada 89030

Skin Cancer and Dermatology Institute
Reno, Nevada 89509

Albuquerque Clinical Trials Incorporated
Albuquerque, New Mexico 87102

Ace Clinical Trials
Brooklyn, New York 11211

Icahn School of Medicine at Mount Sinai
New York, New York 10029

Sadick Research Group
New York, New York 10075

OptiSkin Medical
New York, New York 10128

DJL Clinical Research PLLC
Charlotte, North Carolina 28211

Wilmington Dermatology Center
Wilmington, North Carolina 28405

Accellacare of Wilmington
Wilmington, North Carolina 28411

The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103

Bexley Dermatology Research
Bexley, Ohio 43209

Bernstein Clinical Research Center LLC
Cincinnati, Ohio 45236

The Ohio State University
Gahanna, Ohio 43230

Apex Clinical Research Center LLC
Mayfield Heights, Ohio 44124

Dermatologist of Central States Clinical Research - Springfield
Springfield, Ohio 45505

Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma 74132

Essential Medical Research LLC
Tulsa, Oklahoma 74137

Velocity Clinical Research Medford
Medford, Oregon 97504

Oregon Medical Research Center
Portland, Oregon 97201

Oregon Dermatology and Research Center
Portland, Oregon 97210

Best Skin Research
Camp Hill, Pennsylvania 17011

Paddington Testing Company Inc
Philadelphia, Pennsylvania 19103

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213

Medical University of South Carolina
Charleston, South Carolina 29425

Health Concepts
Rapid City, South Dakota 57702

Cumberland Skin Center
Hermitage, Tennessee 37076

US Dermatology Partners Jollyville
Austin, Texas 78759

Bellaire Dermatology Associates
Bellaire, Texas 77401

US Dermatology Partners Cedar Park
Cedar Park, Texas 78613

Driscoll Childrens Hospital
Corpus Christi, Texas 78411

Alina Clinical Trials, LLC
Dallas, Texas 75225

Dermatology Treatment and Research Center PA
Dallas, Texas 75230

Zenos Clinical Research
Dallas, Texas 75230

Center For Clinical Studies PLLC
Houston, Texas 77004

University of Texas Health Science Center at Houston
Houston, Texas 77030

Sante Clinical Research
Kerrville, Texas 78028

Sms Clinical Research Limited Liability Company
Mesquite, Texas 75149

Texas Dermatology Research Center
Plano, Texas 75025

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218

Stryde Research Epiphany Dermatology
Southlake, Texas 76092

The Woodlands Dermatology Associates
The Woodlands, Texas 77380

University of Utah MidValley Dermatology
Murray, Utah 84107

Education and Research Foundation Inc
Forest, Virginia 24551

Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia 23502

Eastern Virginia Medical School
Norfolk, Virginia 23507

MultiCare Institute for Research and Innovation
Spokane, Washington 99202

More Details

NCT ID
NCT05882877
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

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