A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
Study Purpose
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years - 17 Years |
Gender | All |
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05633355 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Amgen |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
MD |
Principal Investigator Affiliation | Amgen |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Brazil, Canada, Hong Kong, Korea, Republic of, Turkey, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis |
Study Website: | View Trial Website |
Arms
Experimental: Rocatinlimab
Rocatinlimab will be administered subcutaneously every 4 weeks (Q4W) for 52 weeks with one additional dose at Week 2.
Interventions
Drug: - Rocatinlimab
Subcutaneous (SC) injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Phoenix Childrens Hosptial
Phoenix, Arizona, 85016
Status
Recruiting
Address
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283
Status
Recruiting
Address
Dermatology Trial Associates
Bryant, Arkansas, 72022
Status
Recruiting
Address
Little Rock Allergy and Asthma Clinical Research Center
Little Rock, Arkansas, 72205
Status
Recruiting
Address
University of California Irvine
Irvine, California, 92697
Status
Recruiting
Address
University of California Los Angeles
Los Angeles, California, 90024
Status
Recruiting
Address
Dermatology Research Associates
Los Angeles, California, 90045
Status
Recruiting
Address
Manlio Dermatology
Kissimmee, Florida, 34741
Status
Recruiting
Address
Deluxe Health Care LLC
Miami Lakes, Florida, 33014
Status
Recruiting
Address
Palm Springs Community Health Center
Miami, Florida, 33014
Status
Recruiting
Address
ARA Professionals LLC
Miami, Florida, 33176
Status
Recruiting
Address
Bluegrass Allergy Care
Lexington, Kentucky, 40509
Status
Recruiting
Address
Windsor Dermatology dba Eczema Treatment Center of New Jersey
East Windsor, New Jersey, 08520
Status
Recruiting
Address
Smart Medical Research Inc
Jackson Heights, New York, 11372
Status
Recruiting
Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Status
Recruiting
Address
Auni Allergy
Findlay, Ohio, 45840
Status
Recruiting
Address
Oregon Medical Research Center
Portland, Oregon, 97201
Status
Terminated
Address
DermDox Dermatology, LLC
Sugarloaf, Pennsylvania, 18249
Status
Recruiting
Address
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411
Status
Recruiting
Address
Modern Research Associates
Dallas, Texas, 75231
Status
Recruiting
Address
Center for Clinical Studies
Houston, Texas, 77004
Status
Recruiting
Address
University of Utah MidValley Dermatology
Murray, Utah, 84107
International Sites
Status
Recruiting
Address
Cinme - Centro de Investigaciones Metabolicas
Caba, Buenos Aires, C1027AAP
Status
Recruiting
Address
Fundacion Cidea
Ciudad Autonoma de Buenos Aires, Distrito Federal, 1121
Status
Recruiting
Address
Instituto de Neumonologia y Dermatologia
Ciudad Autonoma de Buenos Aires, Distrito Federal, 1425
Status
Recruiting
Address
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Fundacion Estudios Clinicos
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Instituto de Diagnostico Abc American British Cowdray
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Woden Dermatology
Phillip, Australian Capital Territory, 2606
Status
Recruiting
Address
The Skin Hospital
Darlinghurst, New South Wales, 2010
Status
Recruiting
Address
Premier Specialists
Kogarah, New South Wales, 2217
Status
Recruiting
Address
Liverpool Hospital
Liverpool, New South Wales, 2170
Status
Recruiting
Address
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Status
Recruiting
Address
The Skin Centre
Benowa, Queensland, 4217
Status
Recruiting
Address
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Status
Recruiting
Address
Monash Childrens Hospital
Clayton, Victoria, 3168
Status
Recruiting
Address
Institute for Skin Health and Immunity
Mitcham, Victoria, 3132
Status
Recruiting
Address
Universidade Federal do Parana
Curitiba, Paraná, 80060-240
Status
Recruiting
Address
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande Do Sul, 90160-093
Status
Recruiting
Address
Fundacao Abc - Centro Univ Fmabc
Santo Andre, São Paulo, 09060-870
Status
Recruiting
Address
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Sao Paulo, São Paulo, 01308-050
Status
Recruiting
Address
Ispem-Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo, 12243-280
Status
Recruiting
Address
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
São Paulo, , 06454-010
Status
Recruiting
Address
Dermatology Research Institute Incorporated
Calgary, Alberta, T2J 7E1
Status
Recruiting
Address
Stratica Dermatology
Edmonton, Alberta, T5K 1X3
Status
Recruiting
Address
Vida Clinical Research
Edmonton, Alberta, T6H 4J8
Status
Recruiting
Address
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
Status
Recruiting
Address
Skincare Studio
St. John's, Newfoundland and Labrador, A1E 1V4
Status
Recruiting
Address
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1
Status
Recruiting
Address
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
Status
Recruiting
Address
LEADER Research
Hamilton, Ontario, L8L 3C3
Status
Recruiting
Address
Triple A Lab
Hamilton, Ontario, L8S 1G5
Status
Recruiting
Address
JRB Research Incorporated
Ottawa, Ontario, K2C 3N2
Status
Recruiting
Address
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Status
Recruiting
Address
Toronto Research Centre Inc
Toronto, Ontario, M3H 5Y8
Status
Recruiting
Address
FACET Dermatology
Toronto, Ontario, M4E 1R7
Status
Recruiting
Address
Queen Mary Hospital
Hong Kong, ,
Status
Recruiting
Address
Korea University Ansan Hospital
Ansansi, Gyeonggido, , 15355
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Recruiting
Address
National Medical Center
Seoul, , 04564
Status
Recruiting
Address
Kyung Hee University Hospital at Gangdong
Seoul, , 05278
Status
Recruiting
Address
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , 06591
Status
Recruiting
Address
Chung-Ang University Hospital
Seoul, , 06973
Status
Recruiting
Address
Hallym University Kangnam Sacred Heart Hospital
Seoul, , 07441
Status
Recruiting
Address
Ewha Womans University Seoul Hospital
Seoul, , 07804
Status
Recruiting
Address
Bezmialem Vakif Universitesi Hastanesi
Istanbul, , 34093
Status
Recruiting
Address
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , 34098
Status
Recruiting
Address
Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
Izmir, , 35620
Status
Recruiting
Address
Erciyes Universitesi Tip Fakultesi Hastanesi
Kayseri, , 38030
Status
Recruiting
Address
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , 55200
Status
Recruiting
Address
Bristol Royal Hospital for Children
Bristol, , BS2 8BJ
Status
Terminated
Address
Velocity Clinical Research, High Wycombe
High Wycombe, , HP11 2QW
Status
Recruiting
Address
Alder Hey Childrens Hospital
Liverpool, , L12 2AP
Status
Recruiting
Address
Whipps Cross University Hospital
London, , E11 1NR
Status
Recruiting
Address
St Thomas Hospital
London, , SE1 7EH
Status
Recruiting
Address
Carn to Coast Health Centres
Redruth, , TR16 4ET