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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05633355

Public ClinicalTrials.gov record NCT05633355. 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 May 14, 2026, 10:14 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, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

Study identification

NCT ID
NCT05633355
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
187 participants

Conditions and interventions

Interventions

  • Rocatinlimab Drug

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
Jan 29, 2023
Primary completion
Jul 30, 2025
Completion
Jul 30, 2025
Last update posted
Dec 10, 2025

2023 – 2025

United States locations

U.S. sites
22
U.S. states
12
U.S. cities
20
Facility City State ZIP Site status
Phoenix Childrens Hosptial Phoenix Arizona 85016
Medical Advancement Centers of Arizona Tempe Arizona 85283
Dermatology Trial Associates Bryant Arkansas 72022
Little Rock Allergy and Asthma Clinical Research Center Little Rock Arkansas 72205
University of California Irvine Irvine California 92697
University of California Los Angeles Los Angeles California 90024
Dermatology Research Associates Los Angeles California 90045
Manlio Dermatology Kissimmee Florida 34741
Palm Springs Community Health Center Miami Florida 33014
ARA Professionals Limited Liability Corporation Miami Florida 33176
Deluxe Health Care LLC Miami Lakes Florida 33014
Bluegrass Allergy Care Lexington Kentucky 40509
Windsor Dermatology dba Eczema Treatment Center of New Jersey East Windsor New Jersey 08520
Smart Medical Research Inc Jackson Heights New York 11372
Icahn School of Medicine at Mount Sinai New York New York 10029
Auni Allergy Findlay Ohio 45840
Oregon Medical Research Center Portland Oregon 97201
DermDox Dermatology, LLC Sugarloaf Pennsylvania 18249
Driscoll Childrens Hospital Corpus Christi Texas 78411
Modern Research Associates Dallas Texas 75231
Center for Clinical Studies Houston Texas 77004
University of Utah MidValley Dermatology Murray Utah 84107

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 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05633355, 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 Dec 10, 2025 · Synced May 14, 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 protocol, eligibility criteria, and contact information for NCT05633355 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →