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A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445

CompletedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis

Interventions: Rocatinlimab, Placebo

Countries: United States, Argentina, Brazil, Canada, China, Croatia, Czechia, Germany

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

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 Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* 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
  * Systemic immunosuppressants
  * Phototherapy
  * 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 inhibitors
  * Other topical immunosuppressive agents
  * Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Locations (202)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Anaheim, California, United States
  • Fountain Valley, California, United States
  • Glendale, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sherman Oaks, California, United States
  • Centennial, Colorado, United States
  • Boca Raton, Florida, United States
  • Delray Beach, Florida, United States
  • Homestead, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • West Dundee, Illinois, United States
  • Plainfield, Indiana, United States
  • Chevy Chase, Maryland, United States
  • Towson, Maryland, United States
  • Detroit, Michigan, United States
  • Flint, Michigan, United States
  • Lee's Summit, Missouri, United States
  • Las Vegas, Nevada, United States
  • Portsmouth, New Hampshire, United States
  • + 172 more on CT.gov