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COMPLETEDPHASE3

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

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)

NCT05633355•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 12 to \< 18 years at day 1.
•Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield, 2014\]) that has been present for at least 12 months before signing of informed consent
•Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
•Eczema Area and Severity Index (EASI) score ≥ 12
•vIGA-AD score ≥ 3
•≥ 10% BSA of AD involvement at day 1 pre-enrollment

Exclusion Criteria

•Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
•Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
•* Systemic corticosteroids
•* Systemic immunosuppressants
•* Phototherapy
•* Oral or topical janus kinase inhibitors
•Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
•* Topical PDE4 inhibitors
•* Other topical immunosuppressive agents (not including TCS/TCI)
•* Combination topical agents containing a high- or super-high potency corticosteroid

Locations (77)

Phoenix Childrens Hosptial

Phoenix, Arizona, United States

Medical Advancement Centers of Arizona

Tempe, Arizona, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

Little Rock Allergy and Asthma Clinical Research Center

Little Rock, Arkansas, United States

University of California Irvine

Irvine, California, United States

University of California Los Angeles

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Manlio Dermatology

Kissimmee, Florida, United States

Palm Springs Community Health Center

Miami, Florida, United States

ARA Professionals Limited Liability Corporation

Miami, Florida, United States

Key Dates

Start Date

January 30, 2023

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

December 11, 2025

Enrollment

187

ACTUAL participants

Conditions

Atopic Dermatitis

Interventions

Rocatinlimab

DRUG

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

NCT07262983

Hyper IgE Syndrome From STAT3 MutationJob s Syndrome+3 more

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RECRUITINGPHASE3

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

NCT06389136

Atopic Dermatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis