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Trial ID IM034-1014  |   NCT06248814

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-75
    Age Range
  • 11
    Locations
  • BMS Recruiting Study icon
    Recruiting

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
    1. 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
      1. All the following must be present to confirm moderate-to-severe AD
        1. Eczema Area and Severity Index score ≥ 12 (at Screening and Day 1)
          1. Body Surface Area ≥ 10% (at Screening and Day 1)
            1. Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1)
              1. Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)

                Exclusion Criteria

                Exclusion Criteria Icon
                :
                • Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
                  1. 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
                    1. Any other sound medical, psychiatric, and/or social reason as determined by the investigator Other protocol-defined inclusion/exclusion criteria apply
                      Additional Information *

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: BMS-986326 Dose A, followed by Placebo

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: BMS-986326 Dose B, followed by Placebo

                      ASSIGNED INTERVENTION

                      Study Arms

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

                      ASSIGNED INTERVENTION
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