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
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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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2024-03-06
2025-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo, followed by BMS-986326 Dose A or Dose B
BMS-986326
Specified dose on specified days
Placebo
Specified dose on specified days
BMS-986326 Dose A, followed by Placebo
BMS-986326
Specified dose on specified days
Placebo
Specified dose on specified days
BMS-986326 Dose B, followed by Placebo
BMS-986326
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986326
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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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
Local Institution - 0009
Pardubice, , Czechia
Local Institution - 0006
Clermont-Ferrand, , France
Local Institution - 0010
Nice, , France
Local Institution - 0008
Pierre-Bénite, , France
Local Institution - 0005
Chemnitz, Saxony, Germany
Local Institution - 0012
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0011
Berlin, State of Berlin, Germany
Local Institution - 0015
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0001
Rzeszów, Podkarpackie Voivodeship, Poland
Local Institution - 0016
Katowice, Silesian Voivodeship, Poland
Local Institution - 0013
Las Palmas de Gran Canaria, GC, Spain
Local Institution - 0002
Córdoba, X, Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
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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