Summary

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

Description

Summary

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

Official Title

A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)

Keywords

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

Eligibility

You can join if…

Open to people ages 12-17

  • Age ≥ 12 to < 18 years at day 1.
  • Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield, 2014]) that has been present for at least 12 months before signing of informed consent
  • Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors [TCI] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
  • Eczema Area and Severity Index (EASI) score ≥ 12
  • vIGA-AD score ≥ 3
  • ≥ 10% BSA of AD involvement at day 1 pre-enrollment

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:
    • Systemic corticosteroids
    • Systemic immunosuppressants
    • Phototherapy
    • Oral or topical janus kinase inhibitors
  • Treatment with any of the following agents within 1 week before day 1 pre-enrollment:
    • Topical PDE4 inhibitors
    • Other topical immunosuppressive agents (not including TCS/TCI)
    • Combination topical agents containing a high- or super-high potency corticosteroid

Locations

  • University of California Irvine
    Irvine California 92697 United States
  • University of California Los Angeles
    Los Angeles California 90024 United States
  • Dermatology Research Associates
    Los Angeles California 90045 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05633355
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
About 187 people participating
Last Updated