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

NCT ID: NCT06248814

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2025-11-06

Brief Summary

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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).

Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

BMS-986326 Dose A, followed by Placebo

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

BMS-986326 Dose B, followed by Placebo

Group Type EXPERIMENTAL

BMS-986326

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986326

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0004

Prague, PR, Czechia

Site Status

Local Institution - 0009

Pardubice, , Czechia

Site Status

Local Institution - 0006

Clermont-Ferrand, , France

Site Status

Local Institution - 0010

Nice, , France

Site Status

Local Institution - 0008

Pierre-Bénite, , France

Site Status

Local Institution - 0005

Chemnitz, Saxony, Germany

Site Status

Local Institution - 0012

Lübeck, Schleswig-Holstein, Germany

Site Status

Local Institution - 0011

Berlin, State of Berlin, Germany

Site Status

Local Institution - 0015

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Local Institution - 0001

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

Local Institution - 0016

Katowice, Silesian Voivodeship, Poland

Site Status

Local Institution - 0013

Las Palmas de Gran Canaria, GC, Spain

Site Status

Local Institution - 0002

Córdoba, X, Spain

Site Status

Countries

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Czechia France Germany Poland Spain

Related Links

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Other Identifiers

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2022-502997-18

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM034-1014

Identifier Type: -

Identifier Source: org_study_id

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