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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT05882877

Run by

Amgen

People needed

2621

Starts

2023-05-31

Expected to finish

2026-07-01

Last updated by the study team

2026-07-16

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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 1.

Where it is running

• 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
• West Coast Research LLC — Dublin, California, United States
• California Dermatology and Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• Chemidox Clinical Trials Incorporated — Lancaster, California, United States
• Long Beach Research Institute — Long Beach, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Wallace Medical Group Inc — Los Angeles, California, United States
• Northridge Clinical Trials — Northridge, California, United States
• University of California Irvine — Orange, California, United States
• Havana Research Institute Inc — Pasadena, California, United States
• Integrative Skin Science and Research — Sacramento, California, United States
• University of California at Davis Medical Center — Sacramento, California, United States
• Kaiser Permanente South Sacramento Medical Center — Sacramento, California, United States
• Cahaba Dermatology and Skin Health Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.