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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05704738

Run by

Amgen

People needed

532

Starts

2023-04-20

Expected to finish

2025-11-25

Last updated by the study team

2026-01-16

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.
• Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
• Body weight ≥ 40 kg at screening.
• History of inadequate response to TCS of medium to higher potency (with or without TCI).
• EASI score ≥ 12 at initial screening.
• EASI score ≥ 16 at Day 1.
• vIGA-AD score ≥ 3.
• ≥10% body surface area of AD involvement.
• Worst pruritus NRS ≥ 4.

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
• Non-biologic, non-targeted systemic immunosuppressants
• Phototherapy
• Oral or Topical Janus kinase inhibitors
• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
• TCS of any potency
• TCI
• Topical phosphodiesterase 4 inhibitors
• Other topical immunosuppressive agents

Where it is running

• AllerVie Clinical Research- Cullman — Cullman, Alabama, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• Arkansas Research Trials, LLC — North Little Rock, Arkansas, United States
• Center for Dermatology Clinical Research Inc — Fremont, California, United States
• Doc1 Healthcare Systems Incorporated — Fullerton, California, United States
• Axon Clinical Research — Inglewood, California, United States
• Avance Clinical Trials — Laguna Niguel, California, United States
• Cura Clinical Research — Palmdale, California, United States
• Integrative Skin Science and Research — Sacramento, California, United States
• University of California at Davis Medical Center — Sacramento, California, United States
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
• University of California at San Diego Rady Childrens Hospital San Diego — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Cura Clinical Research Sherman Oaks — Sherman Oaks, California, United States
• Velocity Clinical Research - Denver — Denver, Colorado, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• Clinical Research of Brandon — Brandon, Florida, United States
• Academic Alliance in Dermatology - Saint Petersburg Office — Clearwater, Florida, United States
• Corazon United States of America, LLC doing business as Life Clinical Trials — Coral Springs, Florida, United States
• Palm Beach Dermatology Group — Delray Beach, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Glick Skin Institute — Margate, Florida, United States
• Miami Clinical Research — Miami, Florida, United States
• ara Professionals Limited Liability Corporation — Miami, Florida, United States
• Cahaba Dermatology and Skin Health Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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