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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT05633355Tipo: INTERVENTIONALInicio: 30 de ene de 2023Fin estimado: 31 de jul de 2025

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Rocatinlimab

Subcutaneous (SC) injection

Ubicaciones

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Distrito Federal, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, Argentina

Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario

Rosario, Santa Fe Province, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Instituto de Diagnostico ABC

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalAmgen

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