A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis
- Registration Number
- NCT06248814
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
-
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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, followed by BMS-986326 Dose A or Dose B Placebo - BMS-986326 Dose A, followed by Placebo Placebo - BMS-986326 Dose B, followed by Placebo BMS-986326 - BMS-986326 Dose B, followed by Placebo Placebo - Placebo, followed by BMS-986326 Dose A or Dose B BMS-986326 - BMS-986326 Dose A, followed by Placebo BMS-986326 -
- Primary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to approximately 224 days Number of participants with adverse events (AEs) Up to approximately 224 days Number of participants with vital sign abnormalities Up to approximately 224 days Number of participants with physical examination abnormalities Up to approximately 224 days Number of participants with serious adverse events (SAEs) Up to approximately 224 days Number of participants with electrocardiogram (ECG) abnormalities Up to approximately 224 days
- Secondary Outcome Measures
Name Time Method Mean percentage change from baseline at selected visits through 112 days in EASI score Up to approximately 112 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 Maximum observed concentration (Cmax) Up to approximately 224 days Time of maximum observed concentration (Tmax) Up to approximately 224 days
Trial Locations
- Locations (14)
Local Institution - 0003
🇵🇱Wroclaw, DS, Poland
Clintrial s.r.o.
🇨🇿Praha, PR, Czechia
Pratia Pardubice a.s.
🇨🇿Pardubice, Czechia
CHU Estaing
🇫🇷Clermont-Ferrand, France
CHU de Nice - L'Archet
🇫🇷Nice, France
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
🇩🇪Berlin, BE, Germany
Local Institution - 0017
🇩🇪Dessau-Rosslau, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Exzellenzzentrum Entzuendungsmedizin
🇩🇪Lubeck, SH, Germany
DRK Krankenhaus Chemnitz-Rabenstein, Hautklinik
🇩🇪Chemnitz, SN, Germany
Malopolskie Centrum Kliniczne
🇵🇱Krakow, MA, Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
🇵🇱Rzeszow, Podkarpackie, Poland
Centrum Medyczne Pratia - Katowice
🇵🇱Katowice, SL, Poland
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas de Gran Canaria, GC, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, X, Spain