NCT06224192CompletedPhase 3
A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
A Phase 3, Multicenter, Randomized, Open-label, Performance Study With Self-administered Subcutaneous Rocatinlimab (AMG 451) in Adolescent and Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Outpost)
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 151 (actual)
- First submitted
- 17 Jan 2024
- Start date
- Apr 2024
- Primary completion date
- Apr 2025
- Lead sponsor
- Amgen
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06224192
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 151
- From Apr 2024 to the primary completion date, Apr 2025
- 47 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
- Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
- Systemic corticosteroids
- Non-biologic, non-targeted systemic immunosuppressants
- Oral or Topical Janus kinase inhibitors
- Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
- Topical phosphodiesterase 4 (PDE4) inhibitors
- Other topical immunosuppressive agents (not including TCS/TCI)
- Combination topical agents containing any of the above components
Who the study is looking for
- Age ≥ 12 at Day 1.
- Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
- History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
- Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
- ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
Age in the registry: 12 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leader Research Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Interior Dermatology Centre Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Lynderm Research Inc. Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| DermEdge Research Incorporated Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Allergy Research Canada Incorporated Coordinator of this site? Confirm its status | Niagara Falls | Canada | Unknown status |
| North Bay Dermatology Centre Coordinator of this site? Confirm its status | North Bay | Canada | Unknown status |
| Dermatology Ottawa Research Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Skinsense Medical Research Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| FACET Dermatology Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Alliance Clinical Trials Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| XLR8 Medical Research, Incorporated Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| Matsuo Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Ekihigashi Dermatology Allergy Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Suizenji Dermatology Clinic Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Mita Dermatology Clinic Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Dermatology and Ophthalmology Kume Clinic Coordinator of this site? Confirm its status | Sakai-shi | Japan | Unknown status |
| Keio University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Korea University Ansan Hospital Coordinator of this site? Confirm its status | Ansan-si, Gyeonggi-do | South Korea | Unknown status |
| Kyung Hee University Hospital at Gangdong Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hallym University Kangnam Sacred Heart Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon-si Gyeonggi-do | South Korea | Unknown status |
| Hamilton Research LLC Coordinator of this site? Confirm its status | Alpharetta | United States | Unknown status |
| Kern Research, Inc Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Bexley Dermatology Research Coordinator of this site? Confirm its status | Bexley | United States | Unknown status |
| Treasure Valley Medical Research Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Cumberland Skin Center Coordinator of this site? Confirm its status | Hermitage | United States | Unknown status |
| Direct Helpers Research Center Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Excel Clinical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Dermatology and Skin Cancer Center Leawood Coordinator of this site? Confirm its status | Leawood | United States | Unknown status |
| Long Beach Research Institute Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Dermatology Research Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Apex Clinical Research Center, LLC Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Sms Clinical Research Limited Liability Company Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Anchor Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Virginia Dermatology and Skin Cancer Center Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Las Vegas Clinical Trials Coordinator of this site? Confirm its status | North Las Vegas | United States | Unknown status |
| Havana Research Institute Inc Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Texas Dermatology Research Center Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Health Concepts Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Skin Cancer and Dermatology Institute Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Integrative Skin Science and Research Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Essential Medical Research LLC Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| The Skin Surgery Center for Clinical Research Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.