A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
- Registration Number
- NCT05633355
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 187
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rocatinlimab Rocatinlimab Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Serious Adverse Events Up to 52 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
University of California Los Angeles
🇺🇸Los Angeles, California, United States
ARA Professionals Limited Liability Corporation
🇺🇸Miami, Florida, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Fundacion Cidea
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Auni Allergy
🇺🇸Findlay, Ohio, United States
Manlio Dermatology
🇺🇸Kissimmee, Florida, United States
Medical Advancement Centers of Arizona
🇺🇸Tempe, Arizona, United States
University of California Irvine
🇺🇸Irvine, California, United States
Deluxe Health Care LLC
🇺🇸Miami Lakes, Florida, United States
Driscoll Childrens Hospital
🇺🇸Corpus Christi, Texas, United States
Smart Medical Research Inc
🇺🇸Jackson Heights, New York, United States
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Diagnostico ABC
🇦🇷Rosario, Santa Fe, Argentina
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Bluegrass Allergy Care
🇺🇸Lexington, Kentucky, United States
Dermatology Research Institute Incorporated
🇨🇦Calgary, Alberta, Canada
Palm Springs Community Health Center
🇺🇸Miami, Florida, United States
SimcoDerm Medical and Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
Institute for Skin Health and Immunity
🇦🇺Mitcham, Victoria, Australia
DermDox Dermatology, LLC
🇺🇸Sugarloaf, Pennsylvania, United States
FACET Dermatology
🇨🇦Toronto, Ontario, Canada
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
SKiN Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Instituto de Neumonologia y Dermatologia
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
🇹🇷Samsun, Turkey
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Stratica Dermatology
🇨🇦Edmonton, Alberta, Canada
Vida Clinical Research
🇨🇦Edmonton, Alberta, Canada
Monash Childrens Hospital
🇦🇺Clayton, Victoria, Australia
Toronto Research Centre Inc
🇨🇦Toronto, Ontario, Canada
Istanbul Universitesi Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Velocity Clinical Research, High Wycombe
🇬🇧High Wycombe, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
LEADER Research
🇨🇦Hamilton, Ontario, Canada
Winnipeg Clinic Dermatology Research
🇨🇦Winnipeg, Manitoba, Canada
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Little Rock Allergy and Asthma Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Windsor Dermatology dba Eczema Treatment Center of New Jersey
🇺🇸East Windsor, New Jersey, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
University of Utah MidValley Dermatology
🇺🇸Murray, Utah, United States
Woden Dermatology
🇦🇺Phillip, Australian Capital Territory, Australia
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Cinme - Centro de Investigaciones Metabolicas
🇦🇷Caba, Buenos Aires, Argentina
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
The Skin Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Premier Specialists
🇦🇺Kogarah, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
🇧🇷Sao Paulo, São Paulo, Brazil
Ispem-Instituto São José dos Campos em Pesquisas Médicas
🇧🇷São José dos Campos, São Paulo, Brazil
Universidade Federal do Parana
🇧🇷Curitiba, Paraná, Brazil
Fundacao Abc - Centro Univ Fmabc
🇧🇷Santo Andre, São Paulo, Brazil
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
🇧🇷São Paulo, Brazil
Skincare Studio
🇨🇦St. John's, Newfoundland and Labrador, Canada
Halton Pediatric Allergy
🇨🇦Burlington, Ontario, Canada
Triple A Lab
🇨🇦Hamilton, Ontario, Canada
JRB Research Incorporated
🇨🇦Ottawa, Ontario, Canada
Korea University Ansan Hospital
🇰🇷Ansansi, Gyeonggido, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
National Medical Center
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Bezmialem Vakif Universitesi Hastanesi
🇹🇷Istanbul, Turkey
Bristol Royal Hospital for Children
🇬🇧Bristol, United Kingdom
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
🇹🇷Izmir, Turkey
Erciyes Universitesi Tip Fakultesi Hastanesi
🇹🇷Kayseri, Turkey
Carn to Coast Health Centres
🇬🇧Redruth, United Kingdom
Whipps Cross University Hospital
🇬🇧London, United Kingdom
Alder Hey Childrens Hospital
🇬🇧Liverpool, United Kingdom
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Phoenix Childrens Hosptial
🇺🇸Phoenix, Arizona, United States
University of Hong Kong, Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong