Open Actively Recruiting

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

About

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 3

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
23-5180
Category
Healthy Volunteers
Contact
April Armstrong
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05899816
For detailed technical eligibility, visit ClinicalTrials.gov.