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

Last updated: February 18, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Allergy

Rash

Dermatitis, Atopic

Treatment

Placebo

BMS-986326

Clinical Study ID

NCT06248814
IM034-1014
2022-502997-18
  • Ages 18-75
  • All Genders

Study Summary

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 Criteria

Inclusion

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 forat least 4 weeks, unless topical treatments are otherwise medically inadvisable, orhas 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 (atScreening and Day 1)

  • Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)

Exclusion

Exclusion Criteria:

  • Evidence of an active and/or concurrent inflammatory skin condition that wouldinterfere with the Investigator or subject-driven evaluations of AD

  • Any major surgery within the last 30 days before the first dose of studyintervention, or any surgery planned during the course of the study

  • Any other sound medical, psychiatric, and/or social reason as determined by theinvestigator

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
March 06, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Clintrial s.r.o.

    Praha, PR 100 00
    Czechia

    Active - Recruiting

  • Local Institution - 0009

    Pardubice, 530 02
    Czechia

    Site Not Available

  • Pratia Pardubice a.s.

    Pardubice, 530 02
    Czechia

    Active - Recruiting

  • CHU Estaing

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • CHU de Nice - L'Archet

    Nice, 06200
    France

    Active - Recruiting

  • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, BE 10117
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Exzellenzzentrum Entzuendungsmedizin

    Lubeck, SH 23562
    Germany

    Active - Recruiting

  • DRK Krankenhaus Chemnitz-Rabenstein, Hautklinik

    Chemnitz, SN 09117
    Germany

    Active - Recruiting

  • Local Institution - 0005

    Chemnitz, SN 09117
    Germany

    Site Not Available

  • Local Institution - 0017

    Dessau-Rosslau, Saxony-Anhalt 06847
    Germany

    Site Not Available

  • Local Institution - 0003

    Wroclaw, DS 51-685
    Poland

    Site Not Available

  • Local Institution - 0015

    Krakow, MA 30-149
    Poland

    Site Not Available

  • Malopolskie Centrum Kliniczne

    Krakow, MA 30-149
    Poland

    Active - Recruiting

  • Local Institution - 0001

    Rzeszow, Podkarpackie 35-055
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszow, Podkarpackie 35-055
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia - Katowice

    Katowice, SL 40-081
    Poland

    Active - Recruiting

  • Local Institution - 0016

    Katowice, SL 40-081
    Poland

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, GC 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, X 14004
    Spain

    Active - Recruiting

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