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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Specified dose on specified days
Specified dose on specified days
Local Institution - 0004
Prague, PR, Czechia
Local Institution - 0009
Pardubice, Czechia
Local Institution - 0006
Clermont-Ferrand, France
Number of participants with adverse events (AEs)
Time frame: Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 224 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 224 days
Number of participants with vital sign abnormalities
Time frame: Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 224 days
Number of participants with physical examination abnormalities
Time frame: Up to approximately 224 days
Maximum observed concentration (Cmax)
Time frame: Up to approximately 224 days
Time of maximum observed concentration (Tmax)
Time frame: 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
Change from baseline in regulatory T cell (Treg) count
Time frame: Up to approximately 224 days
Change from baseline in Treg-to- conventional T cell (Tconv) ratio
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Local Institution - 0010
Nice, France
Local Institution - 0008
Pierre-Bénite, France
Local Institution - 0005
Chemnitz, Saxony, Germany
Local Institution - 0012
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0011
Berlin, State of Berlin, Germany
Local Institution - 0015
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0001
Rzeszów, Podkarpackie Voivodeship, Poland
...and 3 more locations
Time frame: Up to approximately 224 days
Incidence of anti-drug antibody (ADA)
Time frame: 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