A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

CompletadoFase 3ClinicalTrials.gov

ID: NCT05398445Tipo: INTERVENTIONALInicio: 31 de may de 2022Fin estimado: 13 de ene de 2025

Dermatología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Worst pruritus numerical rating scale ≥ 4

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
Janus kinase inhibitors
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
TCS of any potency
TCI
Topical phosphodiesterase type 4 inhibitors
Other topical immunosuppressive agents
Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Intervenciones

drug

Rocatinlimab

Participants will receive Rocatinlimab subcutaneously.

drug

Placebo

Participants will receive a placebo subcutaneously.

Ubicaciones

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, Argentina

Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Derqui, Pilar, Buenos Aires, Argentina

Centro Dermatológico Schejtman

San Miguel, Buenos Aires, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, Argentina

Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, Argentina

Conexa Investigacion Clinica SA

CABA, Distrito Federal, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Instituto de Diagnostico Abc American British Cowdray

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalAmgen

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