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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
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

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Leader Research
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Interior Dermatology Centre
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Lynderm Research Inc.
Coordinator of this site? Confirm its status
MarkhamCanadaUnknown status
DermEdge Research Incorporated
Coordinator of this site? Confirm its status
MississaugaCanadaUnknown status
Allergy Research Canada Incorporated
Coordinator of this site? Confirm its status
Niagara FallsCanadaUnknown status
North Bay Dermatology Centre
Coordinator of this site? Confirm its status
North BayCanadaUnknown status
Dermatology Ottawa Research Centre
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Skinsense Medical Research
Coordinator of this site? Confirm its status
SaskatoonCanadaUnknown status
FACET Dermatology
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Alliance Clinical Trials
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WaterlooCanadaUnknown status
XLR8 Medical Research, Incorporated
Coordinator of this site? Confirm its status
WindsorCanadaUnknown status
Matsuo Clinic
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Ekihigashi Dermatology Allergy Clinic
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FukuokaJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Suizenji Dermatology Clinic
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KumamotoJapanUnknown status
Mita Dermatology Clinic
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Minato-kuJapanUnknown status
Dermatology and Ophthalmology Kume Clinic
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Sakai-shiJapanUnknown status
Keio University Hospital
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Shinjuku-kuJapanUnknown status
Korea University Ansan Hospital
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Ansan-si, Gyeonggi-doSouth KoreaUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Hallym University Kangnam Sacred Heart Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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Suwon-si Gyeonggi-doSouth KoreaUnknown status
Hamilton Research LLC
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AlpharettaUnited StatesUnknown status
Kern Research, Inc
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BakersfieldUnited StatesUnknown status
Bexley Dermatology Research
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BexleyUnited StatesUnknown status
Treasure Valley Medical Research
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BoiseUnited StatesUnknown status
Cumberland Skin Center
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HermitageUnited StatesUnknown status
Direct Helpers Research Center
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HialeahUnited StatesUnknown status
Excel Clinical Research
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Las VegasUnited StatesUnknown status
Dermatology and Skin Cancer Center Leawood
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LeawoodUnited StatesUnknown status
Long Beach Research Institute
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Long BeachUnited StatesUnknown status
Dermatology Research Associates
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Los AngelesUnited StatesUnknown status
Apex Clinical Research Center, LLC
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Mayfield HeightsUnited StatesUnknown status
Sms Clinical Research Limited Liability Company
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MesquiteUnited StatesUnknown status
Anchor Medical Research
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MiamiUnited StatesUnknown status
Virginia Dermatology and Skin Cancer Center
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NorfolkUnited StatesUnknown status
Las Vegas Clinical Trials
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North Las VegasUnited StatesUnknown status
Havana Research Institute Inc
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PasadenaUnited StatesUnknown status
Texas Dermatology Research Center
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PlanoUnited StatesUnknown status
Health Concepts
Coordinator of this site? Confirm its status
Rapid CityUnited StatesUnknown status
Skin Cancer and Dermatology Institute
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RenoUnited StatesUnknown status
Integrative Skin Science and Research
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SacramentoUnited StatesUnknown status
Essential Medical Research LLC
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TulsaUnited StatesUnknown status
The Skin Surgery Center for Clinical Research
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.