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

Recruiting
18 - 75 years of age
Both
Phase 1

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Overview

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).

Eligibility

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

Study details

Dermatitis, Atopic

NCT06248814

Bristol-Myers Squibb

11 June 2024

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