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Completed Phase 3 Interventional Results available

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 Oct 17, 2026, 7:35 AM 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)

Brief summary

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

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

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

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 30, 2023 (Actual)
Primary completion
Jul 31, 2025 (Actual)
Completion
Jul 31, 2025 (Actual)
Last update posted
Jul 24, 2026

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 Jul 24, 2026 · Synced Oct 17, 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 NCT05633355 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →