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ACTIVE_NOT_RECRUITINGPHASE3

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 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)

NCT05882877•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion 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).

Exclusion Criteria

•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.

Locations (547)

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, United States

Medical Dermatology Specialists

Phoenix, Arizona, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

Affiliated Dermatology

Scottsdale, Arizona, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Dermatology Trial Associates

Bryant, Arkansas, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Kern Research Inc

Bakersfield, California, United States

Hope Clinical Research LLC

Canoga Park, California, United States

Key Dates

Start Date

May 31, 2023

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

November 3, 2025

Enrollment

2,621

ACTUAL participants

Conditions

Atopic Dermatitis

Interventions

Rocatinlimab

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

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