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

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Single Dose, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 at Two Dose Levels in Adult Participants With Atopic Dermatitis

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).

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: Placebo; Drug: BMS-986326

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Pardubice, Czechia, 530 02
    • Local Institution - 0009
  • PR
    • Prague, PR, Czechia, 100 00
      • Local Institution - 0004
• France
  • Clermont-Ferrand, France, 63003
    • Local Institution - 0006
  • Nice, France, 06200
    • Local Institution - 0010
  • Pierre-Bénite, France, 69495
    • Local Institution - 0008
• Germany
  • Saxony
    • Chemnitz, Saxony, Germany, 09117
      • Local Institution - 0005
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Local Institution - 0012
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Local Institution - 0011
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-149
      • Local Institution - 0015
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Local Institution - 0001
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Local Institution - 0016
• Spain
  • GC
    • Las Palmas de Gran Canaria, GC, Spain, 35010
      • Local Institution - 0013
  • X
    • Córdoba, X, Spain, 14004
      • Local Institution - 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo, followed by BMS-986326 Dose A or Dose B	Other: Placebo; Specified dose on specified days; Drug: BMS-986326; Specified dose on specified days
Experimental: BMS-986326 Dose A, followed by Placebo	Other: Placebo; Specified dose on specified days; Drug: BMS-986326; Specified dose on specified days
Experimental: BMS-986326 Dose B, followed by Placebo	Other: Placebo; Specified dose on specified days; Drug: BMS-986326; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to approximately 224 days
Number of participants with serious adverse events (SAEs)	Up to approximately 224 days
Number of participants with clinical laboratory abnormalities	Up to approximately 224 days
Number of participants with vital sign abnormalities	Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to approximately 224 days
Number of participants with physical examination abnormalities	Up to approximately 224 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Up to approximately 224 days
Time of maximum observed concentration (Tmax)	Up to approximately 224 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to approximately 224 days
Change from baseline in regulatory T cell (Treg) count	Up to approximately 224 days
Change from baseline in Treg-to- conventional T cell (Tconv) ratio	Up to approximately 224 days
Incidence of anti-drug antibody (ADA)	Up to approximately 224 days
Mean percentage change from baseline at selected visits through 112 days in EASI score	Up to approximately 112 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Eczema; Dermatitis; Skin Disease
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases
• Other Study ID Numbers: IM034-1014; 2022-502997-18 (Registry Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes