A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at UC Davis UCSD
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

Official Title

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

Keywords

Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab, Dermatitis, Eczema

Eligibility

You can join if…

Open to people ages 12-17

  • Age ≥ 12 to < 18 years at Day 1.
  • Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
  • Body weight ≥ 40 kg at screening.
  • History of inadequate response to TCS of medium to higher potency (with or without TCI).
  • EASI score ≥ 12 at initial screening.
  • EASI score ≥ 16 at Day 1.
  • vIGA-AD score ≥ 3.
  • ≥10% body surface area of AD involvement.
  • Worst pruritus NRS ≥ 4.

You CAN'T join if...

  • Treatment with a biological 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:
    1. Systemic corticosteroids
    2. Non-biologic, non-targeted systemic immunosuppressants
    3. Phototherapy
    4. Oral or Topical Janus kinase inhibitors

  • Treatment with any of the following medications or therapies within 1 week, prior to

    Day 1:

    1. TCS of any potency
    2. TCI
    3. Topical phosphodiesterase 4 inhibitors
    4. Other topical immunosuppressive agents

Locations

  • University of California at Davis Medical Center accepting new patients
    Sacramento California 95816 United States
  • University of California at San Diego Rady Childrens Hospital San Diego accepting new patients
    San Diego California 92123 United States
  • Clinical Science Institute accepting new patients
    Santa Monica California 90404 United States
  • Cura Clinical Research Sherman Oaks accepting new patients
    Sherman Oaks California 91403 United States
  • Allergy and Asthma Medical Group and Research Center accepting new patients
    San Diego California 92123 United States
  • Axon Clinical Research accepting new patients
    Inglewood California 90301 United States
  • Avance Clinical Trials accepting new patients
    Laguna Niguel California 92677 United States
  • Doc1 Healthcare Systems Incorporated accepting new patients
    Fullerton California 92831 United States
  • Integrative Skin Science and Research accepting new patients
    Sacramento California 95815 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05704738
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated