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

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Brief 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
Primary Purpose
Basic Science
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
54 Years

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

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Study Stats
Protocol No.
23-5180
Category
Healthy Volunteers
Contact
Mark Yamamoto
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05899816
For detailed technical eligibility, visit ClinicalTrials.gov.