A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 12-100 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Keywords

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

Eligibility

You can join if…

Open to people ages 12-100

  • Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
  • Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).

You CAN'T join if...

  • Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90024 United States
  • Clinical Science Institute accepting new patients
    Santa Monica California 90404 United States
  • Dermatology Research Associates accepting new patients
    Los Angeles California 90045 United States
  • Wallace Medical Group Inc accepting new patients
    Los Angeles California 90056 United States
  • Hope Clinical Research LLC accepting new patients
    Canoga Park California 91303 United States
  • Northridge Clinical Trials accepting new patients
    Northridge California 91325 United States
  • Havana Research Institute Inc accepting new patients
    Pasadena California 91105 United States
  • Long Beach Research Institute accepting new patients
    Long Beach California 90805 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT05882877
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 2200 study participants
Last Updated