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

CompletedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis

Interventions: Rocatinlimab, Placebo

Countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Estonia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

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 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

Locations (197)

Litchfield Park, Arizona, United States
Scottsdale, Arizona, United States
Fayetteville, Arkansas, United States
Hot Springs, Arkansas, United States
Chula Vista, California, United States
Dublin, California, United States
Encinitas, California, United States
Fremont, California, United States
La Mesa, California, United States
North Hollywood, California, United States
Palmdale, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Castle Rock, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Cape Coral, Florida, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Margate, Florida, United States
Miami, Florida, United States
Palmetto Bay, Florida, United States
Tampa, Florida, United States
Sandy Springs, Georgia, United States
Normal, Illinois, United States
South Bend, Indiana, United States
West Lafayette, Indiana, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
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