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

Description

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

Conditions

Atopic Dermatitis

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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)

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Cahaba Dermatology and Skin Health Center, Birmingham, Alabama, United States, 35244

Phoenix

Medical Dermatology Specialists, Phoenix, Arizona, United States, 85006

Phoenix

Alliance Dermatology and Mohs Center, Phoenix, Arizona, United States, 85032

Scottsdale

Affiliated Dermatology, Scottsdale, Arizona, United States, 85255

Scottsdale

Scottsdale Clinical Trials, Scottsdale, Arizona, United States, 85260

Bryant

Dermatology Trial Associates, Bryant, Arkansas, United States, 72022

Hot Springs

Burke Pharmaceutical Research, Hot Springs, Arkansas, United States, 71913

North Little Rock

Arkansas Research Trials, LLC, North Little Rock, Arkansas, United States, 72117

Bakersfield

Kern Research Inc, Bakersfield, California, United States, 93301

Canoga Park

Hope Clinical Research LLC, Canoga Park, California, United States, 91303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * 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 1.

Ages Eligible for Study

12 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-05-14