Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05899816). StuddyBuddy aggregates publicly available trial information.