A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06947993Tipo: INTERVENTIONALInicio: 16 de may de 2025Fin estimado: 22 de dic de 2028

Dermatología

Traducción no disponible, mostrando original

Resumen

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

Descripción detallada

This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD. The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Able and willing to sign the informed consent (IC)
Patients with a diagnosis of AD and onset of disease for at least 1 year
Moderate to severe AD

Criterios de exclusión

Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
Participant with any other active inflammatory skin disease
Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)
Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)

Intervenciones

drug

GHZ339

GHZ339 administered at dose A, B, C and D

drug

Placebo

Matching placebo

Ubicaciones

Novartis Investigative Site

Caba, Buenos Aires, Argentina

RECRUITING

Novartis Investigative Site

Caba, Buenos Aires, Argentina

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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