The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Specified dose on specified days
Specified dose on specified days
Local Institution - 0048
San Diego, California, United States
Local Institution - 0055
Clearwater, Florida, United States
Number of participants with adverse events (AEs)
Time frame: Up to 228 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 228 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 228 days
Number of participants with vital sign abnormalities
Time frame: Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 228 days
Number of participants with physical examination abnormalities
Time frame: Up to 228 days
Maximum observed serum concentration (Cmax)
Time frame: Predose and post-dose up to Day 167
Time of Cmax (Tmax)
Time frame: Predose and post-dose up to Day 167
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 167
Serum PK parameters such as AUC(TAU)
Time frame: Predose and post-dose up to Day 167
Change from baseline in regulatory T cells (Treg) count to Day 144
Time frame: Baseline up to Day 144
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Local Institution - 0029
Tampa, Florida, United States
Skin Sciences
Louisville, Kentucky, United States
Local Institution - 0062
Las Vegas, Nevada, United States
Local Institution - 0005
Duncansville, Pennsylvania, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Local Institution - 0070
Pilar, Buenos Aires, Argentina
Local Institution - 0075
CABA, Buenos Aires F.D., Argentina
Local Institution - 0072
Sofia, Bulgaria
...and 10 more locations
Change from baseline in Treg-to-conventional t cells (Tconv) ratio
Time frame: Baseline up to Day 144
Number of participants with anti-drug antibodies
Time frame: Baseline up to Day 167