Clinical trial NCT06224192: A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 151
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.


Eligibility criteria: 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 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.

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

Primary outcomes:
measure: Proportion of Full-dose Self-administered Rocatinlimab Injections Among Total Attempted Injections up to Week 16
timeFrame: Up to Week 16
Secondary outcomes:
measure: Proportion of Devices that Have Been Reported with Product Complaints Related to Function by Participants, Caregivers, or Investigators Among Total Dispensed Devices up to Week 16
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Research Inc
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Pasadena
country: United States
facility: Havana Research Institute Inc
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: Anchor Medical Research
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research, LLC
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Leawood
country: United States
facility: Dermatology and Skin Cancer Center Leawood
state: Kansas
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Winston-Salem
country: United States
facility: The Skin Surgery Center for Clinical Research
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center LLC
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research LLC
state: Oklahoma
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Hermitage
country: United States
facility: Cumberland Skin Center
state: Tennessee
city: Mesquite
country: United States
facility: Sms Clinical Research Limited Liability Company
state: Texas
city: Plano
country: United States
facility: Texas Dermatology Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Kelowna
country: Canada
facility: Interior Dermatology Centre
state: British Columbia
city: Hamilton
country: Canada
facility: LEADER Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Incorporated
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Incorporated
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research, Incorporated
state: Ontario
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Fukuoka-shi
country: Japan
facility: Ekihigashi Dermatology Allergy Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Matsuo Clinic
state: Fukuoka
city: Kumamoto-shi
country: Japan
facility: Suizenji Dermatology Clinic
state: Kumamoto
city: Sakai-shi
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Minato-ku
country: Japan
facility: Mita Dermatology Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Ansan-si, Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: