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Completed
NCT05899816
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
Conditions: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis
Sex: All
Ages: 18 Years – 54 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 221
Sponsor: Amgen
Location: Affiliated Dermatology Scottsdale Arizona
Summary
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 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
Source: ClinicalTrials.gov (NCT05899816). StuddyBuddy aggregates publicly available trial information.