Summary

Eligibility
for people ages 12-100 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends 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, 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 at Davis Medical Center
    Sacramento California 95816 United States
  • Integrative Skin Science and Research
    Sacramento California 95815 United States
  • Kaiser Permanente South Sacramento Medical Center
    Sacramento California 95823 United States

Details

Status
in progress, not 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
About 2621 people participating
Last Updated