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

NCT06248814 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM034-10142022-502997-18
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 13

Brief 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).

Conditions

Dermatitis, Atopic

Keywords

Skin Disease; Dermatitis; Eczema

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (3)

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

EXPERIMENTAL

Drug: BMS-986326; Other: Placebo

BMS-986326 Dose A, followed by Placebo

EXPERIMENTAL

Drug: BMS-986326; Other: Placebo

BMS-986326 Dose B, followed by Placebo

EXPERIMENTAL

Drug: BMS-986326; Other: Placebo

Interventions

BMS-986326 DRUG

Specified dose on specified days

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

Placebo OTHER

Specified dose on specified days

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (13)

Local Institution - 0004

Prague, PR, 100 00, Czechia

Location

Local Institution - 0009

Pardubice, 530 02, Czechia

Location

Local Institution - 0006

Clermont-Ferrand, 63003, France

Location

Local Institution - 0010

Nice, 06200, France

Location

Local Institution - 0008

Pierre-Bénite, 69495, France

Location

Local Institution - 0005

Chemnitz, Saxony, 09117, Germany

Location

Local Institution - 0012

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Local Institution - 0011

Berlin, State of Berlin, 10117, Germany

Location

Local Institution - 0015

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Local Institution - 0001

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Local Institution - 0016

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Local Institution - 0013

Las Palmas de Gran Canaria, GC, 35010, Spain

Location

Local Institution - 0002

Córdoba, X, 14004, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 6, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); CZ (2); FR (3); DE (3); PL (3)