Atopic Dermatitis Clinical Trial
— ROCKET-OutpostOfficial title:
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)
| Verified date | June 2024 |
| Source | Amgen |
| Contact | Amgen Call Center |
| Phone | 866-572-6436 |
| medinfo[@]amgen.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | April 29, 2026 |
| Est. primary completion date | May 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 100 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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: 1. Systemic corticosteroids 2. Non-biologic, non-targeted systemic immunosuppressants 3. Oral or Topical Janus kinase inhibitors - Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization: 1. Topical phosphodiesterase 4 (PDE4) inhibitors 2. Other topical immunosuppressive agents (not including TCS/TCI) 3. Combination topical agents containing any of the above components |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Interior Dermatology Centre | Kelowna | British Columbia |
| Canada | Lynderm Research Inc | Markham | Ontario |
| Canada | DermEdge Research Incorporated | Mississauga | Ontario |
| Canada | Allergy Research Canada Incorporated | Niagara Falls | Ontario |
| Canada | North Bay Dermatology Centre | North Bay | Ontario |
| Canada | Dermatology Ottawa Research Centre | Ottawa | Ontario |
| Canada | Skinsense Medical Research | Saskatoon | Saskatchewan |
| Canada | FACET Dermatology | Toronto | Ontario |
| Canada | Alliance Clinical Trials | Waterloo | Ontario |
| Canada | XLR8 Medical Research, Incorporated | Windsor | Ontario |
| United States | Hamilton Research, LLC | Alpharetta | Georgia |
| United States | Kern Research Inc | Bakersfield | California |
| United States | Bexley Dermatology Research | Bexley | Ohio |
| United States | Treasure Valley Medical Research | Boise | Idaho |
| United States | Cumberland Skin Center | Hermitage | Tennessee |
| United States | Excel Clinical Research | Las Vegas | Nevada |
| United States | Dermatology and Skin Cancer Center Leawood | Leawood | Kansas |
| United States | Long Beach Research Institute | Long Beach | California |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | Apex Clinical Research Center LLC | Mayfield Heights | Ohio |
| United States | Sms Clinical Research Limited Liability Company | Mesquite | Texas |
| United States | Anchor Medical Research | Miami | Florida |
| United States | Virginia Dermatology and Skin Cancer Center | Norfolk | Virginia |
| United States | Las Vegas Clinical Trials | North Las Vegas | Nevada |
| United States | Havana Research Institute Inc | Pasadena | California |
| United States | Texas Dermatology Research Center | Plano | Texas |
| United States | Health Concepts | Rapid City | South Dakota |
| United States | Skin Cancer and Dermatology Institute | Reno | Nevada |
| United States | Integrative Skin Science and Research | Sacramento | California |
| United States | Essential Medical Research LLC | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of full-dose self-administered rocatinlimab injections as reported by participants or caregivers among attempted home-use injections at weeks 4 and 12 combined | Up to Week 12 | ||
| Secondary | Proportion of devices that have been reported with Product Complaints by participants, caregivers, or investigators among dispensed home-use devices at weeks 4 and 12 combined | Up to Week 12 |
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