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

January 31, 2024 updated by: Bristol-Myers Squibb

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Poland
    • MA
      • Krakow, MA, Poland, 30-149
        • Local Institution - 0015
        • Contact:
          • Site 0015
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-055
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • SL
      • Katowice, SL, Poland, 40-081
        • Local Institution - 0016
        • Contact:
          • Site 0016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to approximately 224 days
Up to approximately 224 days
Time of maximum observed concentration (Tmax)
Time Frame: Up to approximately 224 days
Up to approximately 224 days
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
Up to approximately 224 days
Change from baseline in regulatory T cell (Treg) count
Time Frame: Up to approximately 224 days
Up to approximately 224 days
Change from baseline in Treg-to- conventional T cell (Tconv) ratio
Time Frame: Up to approximately 224 days
Up to approximately 224 days
Incidence of anti-drug antibody (ADA)
Time Frame: Up to approximately 224 days
Up to approximately 224 days
Mean percentage change from baseline at selected visits through 112 days in EASI score
Time Frame: Up to approximately 112 days
Up to approximately 112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 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)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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