A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The co-primary objectives of the study are to: * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). * Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Key facts

Study ID

NCT05651711

Run by

Amgen

People needed

726

Starts

2022-12-14

Expected to finish

2024-08-27

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS (Topical Corticosteroid) of medium or 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).
• EASI score ≥16
• vIGA-AD score ≥3
• ≥10% body surface area (BSA) of AD involvement
• Worst pruritus numerical rating scale ≥ 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
• 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 type 4 (PDE4) inhibitors
• Other topical immunosuppressive agents
• Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Where it is running

• Center for Dermatology and Plastic Surgery — Scottsdale, Arizona, United States
• Clinical Trials Institute of Northwest Arkansas — Fayetteville, Arkansas, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Velocity Clinical Research Chula Vista — Chula Vista, California, United States
• West Coast Research LLC — Dublin, California, United States
• California Dermatology and Clinical Research Institute — Encinitas, California, United States
• Center for Dermatology Clinical Research Inc — Fremont, California, United States
• Velocity Clinical Research - San Diego — La Mesa, California, United States
• Velocity Clinical Research - North Hollywood — North Hollywood, California, United States
• Cura Clinical Research — Palmdale, California, United States
• University of California at San Francisco, Dermatology Clinic at Mount Zion — San Francisco, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Clarity Dermatology — Castle Rock, Colorado, United States
• Velocity Clinical Research - Denver — Denver, Colorado, United States
• Foxhall Research Center — Washington D.C., District of Columbia, United States
• Renaissance Research and Medical Group — Cape Coral, Florida, United States
• Driven Research LLC — Coral Gables, Florida, United States
• Saint Jude Clinical Research — Doral, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Glick Skin Institute — Margate, Florida, United States
• Miami Dade Medical Research Institute, LLC — Miami, Florida, United States
• Innovation Medical Research Center Inc — Palmetto Bay, Florida, United States
• University of South Florida Health Morsani Center for Advanced Healthcare — Tampa, Florida, United States
• Advanced Medical Research PC — Sandy Springs, Georgia, United States
• Research Solutions of Arizona, PC — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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