Dermatitis, Atopic
Conditions
Keywords
Skin Disease, Dermatitis, Eczema
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).
Interventions
DRUGBMS-986326
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to approximately 224 days |
| Mean percentage change from baseline at selected visits through 112 days in EASI score | Up to approximately 112 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 |
Countries
Czechia, France, Germany, Poland, Spain
Outcome results
None listed