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Completed

NCT Number: NCT06248814

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in 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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0004, Prague, PR, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986326

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 224 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 224 days

  3. Number of participants with clinical laboratory abnormalities

    Time frame: Up to approximately 224 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 224 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately 224 days

  6. Number of participants with physical examination abnormalities

    Time frame: Up to approximately 224 days

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to approximately 224 days

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately 224 days

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to approximately 224 days

  4. Change from baseline in regulatory T cell (Treg) count

    Time frame: Up to approximately 224 days

  5. Change from baseline in Treg-to- conventional T cell (Tconv) ratio

    Time frame: Up to approximately 224 days

  6. Incidence of anti-drug antibody (ADA)

    Time frame: Up to approximately 224 days

  7. Mean percentage change from baseline at selected visits through 112 days in EASI score

    Time frame: Up to approximately 112 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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