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

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05633355

Run by

Amgen

People needed

187

Starts

2023-01-30

Expected to finish

2025-07-31

Last updated by the study team

2026-07-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Deluxe Health Care LLC — Miami Lakes, Florida, United States
• Bluegrass Allergy Care — Lexington, Kentucky, United States
• Windsor Dermatology dba Eczema Treatment Center of New Jersey — East Windsor, New Jersey, United States
• Smart Medical Research Inc — Jackson Heights, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Auni Allergy — Findlay, Ohio, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• DermDox Dermatology, LLC — Sugarloaf, Pennsylvania, United States
• Driscoll Childrens Hospital — Corpus Christi, Texas, United States
• Modern Research Associates — Dallas, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• University of Utah MidValley Dermatology — Murray, Utah, United States
• Cinme - Centro de Investigaciones Metabolicas — CABA, Buenos Aires, Argentina
• Fundacion Cidea — Buenos Aires, Distrito Federal, Argentina
• Instituto de Neumonologia y Dermatologia — Buenos Aires, Distrito Federal, Argentina
• Phoenix Childrens Hosptial — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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