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A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

NCT05899816

CompletedPhase 3

Sponsor: Amgen

Conditions: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis

Interventions: Rocatinlimab, Placebo

Countries: United States, Canada

The primary objectives of this study are to: * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24 * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at Week 24

Eligibility overview

Sex: ALL

Age: 18 Years to 54 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years to 54 years with a diagnosis of AD according to the American Academy of Dermatology (AAD) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to topical corticosteroids (TCS) of medium, high, or higher potency (with or without topical calcineurin inhibitors)
* Subjects with previous systemic treatment for AD are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout.
* Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score ≥ 3

Exclusion Criteria:

* Treatment with a biologic 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
  * Topical calcineurin inhibitors (TCI)
  * Topical Phosphodiesterase-4 inhibitors (PDE4)
  * Other topical immunosuppressive agents
  * Combination topical agents containing a corticosteroid or calcineurin inhibiting component, PDE4 inhibitors, or other topical immunosuppressive agents
* Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization.
* Treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Locations (85)

Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Canoga Park, California, United States
Chino, California, United States
Inglewood, California, United States
Lancaster, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Pasadena, California, United States
Rolling Hills Estates, California, United States
Sacramento, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Tustin, California, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Destin, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
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