Clinical trial NCT05633355: A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Official title: A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Rocatinlimab
AMG 451
KHK4083
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 187
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 12 to \< 18 years at day 1.
* Participant has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria \[Eichenfield, 2014\]) that has been present for at least 12 months before signing of informed consent
* Prior to informed consent, history of inadequate response to topical corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\] as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)
* Eczema Area and Severity Index (EASI) score ≥ 12
* vIGA-AD score ≥ 3
* ≥ 10% BSA of AD involvement at day 1 pre-enrollment

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Oral or topical janus kinase inhibitors
* Treatment with any of the following agents within 1 week before day 1 pre-enrollment:

  * Topical PDE4 inhibitors
  * Other topical immunosuppressive agents (not including TCS/TCI)
  * Combination topical agents containing a high- or super-high potency corticosteroid

Primary outcomes:
measure: Number of Participants With Treatment-emergent Serious Adverse Events
timeFrame: Up to 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Childrens Hosptial
state: Arizona
city: Tempe
country: United States
facility: Medical Advancement Centers of Arizona
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma Clinical Research Center
state: Arkansas
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Kissimmee
country: United States
facility: Manlio Dermatology
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Care LLC
state: Florida
city: Miami
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: ARA Professionals Limited Liability Corporation
state: Florida
city: Lexington
country: United States
facility: Bluegrass Allergy Care
state: Kentucky
city: East Windsor
country: United States
facility: Windsor Dermatology dba Eczema Treatment Center of New Jersey
state: New Jersey
city: Jackson Heights
country: United States
facility: Smart Medical Research Inc
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Findlay
country: United States
facility: Auni Allergy
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Sugarloaf
country: United States
facility: DermDox Dermatology, LLC
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Driscoll Childrens Hospital
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dermatology
state: Utah
city: Caba
country: Argentina
facility: Cinme - Centro de Investigaciones Metabolicas
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
state: Distrito Federal
city: Rosario
country: Argentina
facility: Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
state: Santa Fe
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Diagnostico ABC
state: Santa Fe
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Clayton
country: Australia
facility: Monash Childrens Hospital
state: Victoria
city: Mitcham
country: Australia
facility: Institute for Skin Health and Immunity
state: Victoria
city: Curitiba
country: Brazil
facility: Universidade Federal do Parana
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: Rio Grande Do Sul
city: Santo Andre
country: Brazil
facility: Fundacao Abc - Centro Univ Fmabc
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
state: São Paulo
city: São José dos Campos
country: Brazil
facility: Ispem-Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: São Paulo
country: Brazil
facility: Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
city: Calgary
country: Canada
facility: Dermatology Research Institute Incorporated
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Vida Clinical Research
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Clinic Dermatology Research
state: Manitoba
city: St. John's
country: Canada
facility: Skincare Studio
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Burlington
country: Canada
facility: Halton Pediatric Allergy
state: Ontario
city: Hamilton
country: Canada
facility: LEADER Research
state: Ontario
city: Hamilton
country: Canada
facility: Triple A Lab
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Incorporated
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre Inc
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong, Queen Mary Hospital
city: Ansansi, Gyeonggido
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Izmir
country: Turkey
facility: Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research, High Wycombe
city: Liverpool
country: United Kingdom
facility: Alder Hey Childrens Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: Redruth
country: United Kingdom
facility: Carn to Coast Health Centres
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: