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Completed Phase 3 Interventional Results available

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ClinicalTrials.gov ID: NCT05704738

Public ClinicalTrials.gov record NCT05704738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 16, 2026, 10:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05704738
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
532 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 20, 2023 (Actual)
Primary completion
Feb 27, 2025 (Actual)
Completion
Nov 25, 2025 (Actual)
Last update posted
Aug 28, 2026

2023 – 2025

United States locations

U.S. sites
98
U.S. states
34
U.S. cities
87
Facility City State ZIP Site status
Cahaba Dermatology and Skin Health Center Birmingham Alabama 35244 —
AllerVie Clinical Research- Cullman Cullman Alabama 35058 —
Eclipse Clinical Research Tucson Arizona 85745 —
Arkansas Research Trials, LLC North Little Rock Arkansas 72117 —
Center for Dermatology Clinical Research Inc Fremont California 94538 —
Doc1 Healthcare Systems Incorporated Fullerton California 92831 —
Axon Clinical Research Inglewood California 90301 —
Avance Clinical Trials Laguna Niguel California 92677 —
Cura Clinical Research Palmdale California 93551 —
Integrative Skin Science and Research Sacramento California 95815 —
University of California at Davis Medical Center Sacramento California 95816 —
Allergy and Asthma Medical Group and Research Center San Diego California 92123 —
University of California at San Diego Rady Childrens Hospital San Diego San Diego California 92123 —
Clinical Science Institute Santa Monica California 90404 —
Cura Clinical Research Sherman Oaks Sherman Oaks California 91403 —
Velocity Clinical Research - Denver Denver Colorado 80209 —
Childrens National Medical Center Washington D.C. District of Columbia 20010 —
Clinical Research of Brandon Brandon Florida 33511 —
Academic Alliance in Dermatology - Saint Petersburg Office Clearwater Florida 33761 —
Corazon United States of America, LLC doing business as Life Clinical Trials Coral Springs Florida 33071 —
Palm Beach Dermatology Group Delray Beach Florida 33484 —
Direct Helpers Research Center Hialeah Florida 33012 —
Glick Skin Institute Margate Florida 33063 —
Miami Clinical Research Miami Florida 33155 —
ara Professionals Limited Liability Corporation Miami Florida 33176 —
Deluxe Health Care LLC Miami Lakes Florida 33014 —
Savin Medical Group LLC Miami Lakes Florida 33014 —
Angels Clinical Research Institute Miami Lakes Florida 33016 —
Optimal Research Sites, LLC Orange City Florida 32763 —
Clinical Associates of Orlando Limited Liability Company Orlando Florida 32819 —
Clinical Research Investments Orlando Florida 32819 —
University of South Florida Tampa Florida 33612 —
Centricity Research Columbus Columbus Georgia 31904 —
Advanced Medical Research PC Sandy Springs Georgia 30328 —
Divine Dermatology and Aesthetics Savannah Georgia 31419 —
McIntosh Clinic PC Thomasville Georgia 31792 —
Treasure Valley Medical Research Boise Idaho 83706-1345 —
Velocity Clinical Research - Boise Meridian Idaho 83642 —
NorthShore University HealthSystem Clinical Trials Center Skokie Illinois 60077 —
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 —
Equity Medical Bowling Green Kentucky 42104 —
Kentucky Advanced Medical Research LLC Murray Kentucky 42071 —
Industrial Medicine Associates Clinical Research Advanced Dermatology Care Monroe Louisiana 71201 —
Aesthetic and Dermatology Center Rockville Maryland 20850 —
Derm Associates, PC Rockville Maryland 20850 —
Oakland Hills Dermatology Auburn Hills Michigan 48326 —
Henry Ford Health System Detroit Michigan 48202 —
Onyx Clinical Research Flint Michigan 48532 —
MediSearch Clinical Trials Saint Joseph Missouri 64506 —
Saint Louis University St Louis Missouri 63110 —
Somnos Clinical Research Lincoln Nebraska 68505 —
Skin Cancer and Dermatology Institute Reno Nevada 89509 —
Allcutis Research Portsmouth New Hampshire 03801 —
The Dermatology Center of New Jersey Bridgewater New Jersey 08807 —
University of New Mexico Albuquerque New Mexico 87102 —
Ace Clinical Trials Brooklyn New York 11211 —
Empire Dermatology East Syracuse New York 13057 —
Smart Medical Research Inc Jackson Heights New York 11372 —
Forest Hills Dermatology Group Kew Gardens New York 11415 —
Pioneer Clinical Research New York New York New York 10016 —
Cornell University - Weill Cornell Medicine New York New York 10075 —
Rochester Clinical Research Rochester New York 14609 —
Yeshiva University - Montefiore Medical Center The Bronx New York 10467 —
Duke South Durham Durham North Carolina 27713 —
Optima Research Boardman Ohio 44512 —
Apex Clinical Research Center LLC Mayfield Heights Ohio 44124 —
Epic Medical Research - Oklahoma Chickasha Oklahoma 73018 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
Dermatology and Aesthetics of Oklahoma Oklahoma City Oklahoma 73120 —
Dermatology Research Center of Oklahoma, PLLC Tulsa Oklahoma 74132 —
Essential Medical Research LLC Tulsa Oklahoma 74137 —
Velocity Clinical Research - Grants Pass Grants Pass Oregon 97527 —
Oregon Health and Science University Portland Oregon 97239 —
Paddington Testing Company Inc Philadelphia Pennsylvania 19103 —
Rhode Island Hospital, Lifespan Providence Rhode Island 02903 —
Medical University of South Carolina Charleston South Carolina 29425 —
National Allergy and Asthma Research, LLC North Charleston South Carolina 29420 —
Coastal Pediatric Research Summerville South Carolina 29486 —
HealthStar Physicians Dermatology Morristown Tennessee 37813 —
The University of Texas Health Science Center at Houston Bellaire Texas 77401 —
US Dermatology Partners Cedar Park Cedar Park Texas 78613 —
Studies in Dermatology LLC Cypress Texas 77429 —
MedCare Pharma - Houston Houston Texas 77037 —
Tranquil Clinical Research Houston Texas 77098 —
Sante Clinical Research Kerrville Texas 78028 —
Long and Harris Dermatology Lubbock Texas 79424 —
Sms Clinical Research Limited Liability Company Mesquite Texas 75149 —
Sienna Dermatology Research Missouri City Texas 77459 —
Texas Dermatology and Laser Specialists San Antonio Texas 78218 —
Epiphany Dermatology Southlake Texas 76092 —
Pioneer Research Solutions Sugar Land Texas 77479 —
Tanner Clinic Murray Utah 84107 —
Dermatology Research of Utah, dba Providence Dermatology Providence Utah 84332 —
Jordan Valley Dermatology Center South Jordan Utah 84095 —
Maria M Ona MD PC Franklin Virginia 23851 —
Northwest Clinical Research Center Bellevue Washington 98007 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 148 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05704738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 28, 2026 · Synced Oct 16, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05704738 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →