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Ícono de BMS, studio Reclutando

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ID del estudio IM034-1014  |   NCT06248814

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis

Resumen

  • Phase 1
  • Ícono de género masculino y femenino
  • 18-75
  • 10
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).

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Criterios clave de elegibilidad

Inclusion Criteria: - Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening - Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease - All the following must be present to confirm moderate-to-severe AD - Eczema Area and Severity Index score ≥ 12 (at Screening and Day 1) - Body Surface Area ≥ 10% (at Screening and Day 1) - Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1) - Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening) Exclusion Criteria: - Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD - Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study - Any other sound medical, psychiatric, and/or social reason as determined by the investigator Other protocol-defined inclusion/exclusion criteria apply

Opciones de tratamiento

Brazos del estudio

INTERVENCIÓN ASIGNADA

Brazos del estudio

Experimental: BMS-986326 Dose A, followed by Placebo

INTERVENCIÓN ASIGNADA

Brazos del estudio

Experimental: BMS-986326 Dose B, followed by Placebo

INTERVENCIÓN ASIGNADA

Brazos del estudio

Experimental: Placebo, followed by BMS-986326 Dose A or Dose B

INTERVENCIÓN ASIGNADA
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