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 UC Davis UCLA
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
  • University of California at Davis Medical Center accepting new patients
    Sacramento California 95816 United States
  • Clinical Science Institute accepting new patients
    Santa Monica California 90404 United States
  • Kaiser Permanente Medical Center - Oakland accepting new patients
    San Francisco California 94118 United States
  • Kaiser Permanente Medical Center - San Francisco accepting new patients
    San Francisco California 94118 United States
  • Dermatology Research Associates accepting new patients
    Los Angeles California 90045 United States
  • Wolverine Clinical Trials accepting new patients
    Tustin California 92780 United States
  • First OC Dermatology accepting new patients
    Fountain Valley California 92708 United States
  • Wallace Medical Group Inc accepting new patients
    Los Angeles California 90056 United States
  • Acclaim Clinical Research accepting new patients
    San Diego California 92120 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