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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Dermatitis, Atopic

Treatments: Other: Placebo; Drug: BMS-986326

Study type: Interventional

Funder types: Industry

Identifiers

NCT06248814

IM034-1014

2022-502997-18 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups

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

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo

BMS-986326 Dose A, followed by Placebo

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo

BMS-986326 Dose B, followed by Placebo

Experimental group

Treatment:

Drug: BMS-986326

Other: Placebo