Summary

Eligibility
for people ages 18-54 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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

Official Title

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

Keywords

Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis, AD, Rocatinlimab, Dermatitis, Eczema, KHK4083

Eligibility

You can join if…

Open to people ages 18-54

  • 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

You CAN'T join if...

  • 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

  • University of California Los Angeles
    Los Angeles California 90024 United States
  • West Los Angeles Clinical Trials
    Los Angeles California 90067 United States
  • Cura Clinical Research
    Sherman Oaks California 91403 United States
  • Wallace Medical Group Inc
    Los Angeles California 90056 United States
  • 310 Clinical Research
    Inglewood California 90301 United States
  • Hope Clinical Research LLC
    Canoga Park California 91303 United States
  • Northridge Clinical Trials
    Northridge California 91325 United States
  • Havana Research Institute Inc
    Pasadena California 91105 United States
  • Peninsula Research Associates
    Rolling Hills Estates California 90274 United States
  • Long Beach Research Institute
    Long Beach California 90805 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website Sign up for this study
ID
NCT05899816
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 221 people participating
Last Updated