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A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05724199

CompletedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis

Interventions: Rocatinlimab, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China

The coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). * evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI 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 with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS of medium or higher potency (with or without TCI)
* 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
  * Nonbiologic, non-targeted Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS
  * TCI
  * Topical phosphodiesterase type 4 inhibitors
  * Other topical immunosuppressive agents
  * Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Locations (234)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
North Little Rock, Arkansas, United States
Bakersfield, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palmdale, California, United States
Sacramento, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
San Francisco, California, United States
Tampa, Florida, United States
Tampa, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Skokie, Illinois, United States
Clarksville, Indiana, United States
Indianapolis, Indiana, United States
Leawood, Kansas, United States
Monroe, Louisiana, United States
Rockville, Maryland, United States
Ann Arbor, Michigan, United States
Auburn Hills, Michigan, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
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