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Recruiting

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis - IM034-1014

Actualizada: 29 mayo, 2024   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-75

    Rango de edad

  • 10

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: BMS-986326 Dose A, followed by Placebo
Experimental: BMS-986326 Dose B, followed by Placebo
Experimental: Placebo, followed by BMS-986326 Dose A or Dose B

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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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