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
44
Specified dose on specified days
Specified dose on specified days
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
First line of the email MUST contain the NCT# and Site #.
CONTACT
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Local Institution - 0048
San Diego, California, United States
COMPLETEDClinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
RECRUITINGClinical Research of West Florida
Tampa, Florida, United States
RECRUITINGNorth Georgia Rheumatology
Lawrenceville, Georgia, United States
WITHDRAWNSkin Sciences
Louisville, Kentucky, United States
RECRUITINGLocal Institution - 0062
Las Vegas, Nevada, United States
COMPLETEDColumbia University Irving Medical Center
New York, New York, United States
WITHDRAWNLocal Institution - 0005
Duncansville, Pennsylvania, United States
COMPLETEDAllen Arthritis
Allen, Texas, United States
WITHDRAWNMetroplex Clinical Research Center
Dallas, Texas, United States
WITHDRAWN...and 17 more locations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