Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986004 · 1 trial · 1 indication
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units \[mcg/ml FEU\]). TAT reference range 0-4.1 ng/ml.
| Arm | Type | Description |
|---|---|---|
| Arm A: BMS-986004 | EXPERIMENTAL | BMS-986004 solution intravenously (IV) as specified |
| Arm B: BMS-986004 | EXPERIMENTAL | BMS-986004 solution intravenously as specified |
| Arm C: BMS-986004 | EXPERIMENTAL | BMS-986004 solution intravenously as specified |
| Arm D: BMS-986004 | EXPERIMENTAL | BMS-986004 solution intravenously as specified |
| Name | Type | Description |
|---|---|---|
| BMS-986004 75 mg IV | DRUG | BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes |
| BMS-986004 225 mg IV | DRUG | BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes |
| BMS-986004 675 mg IV | DRUG | BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes |
| BMS-986004 1500 mg IV | DRUG | BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * ≥18 years old, diagnosed with persistent or chronic ITP Exclusion Criteria: * Secondary immune thrombocytopenia * Drug induced thrombocytopenia
BMS-986004 is being studied for the treatment of immune thrombocytopenic purpura, a hematologic condition in which the immune system destroys platelets. It is a small molecule therapeutic candidate developed by Bristol-Myers Squibb. The program is in Phase 1 clinical development.
BMS-986004 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating the drug in immune thrombocytopenic purpura.
BMS-986004 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program in immune thrombocytopenic purpura has been completed, with one trial conducted and no active trials currently listed.
BMS-986004 has been evaluated in one completed Phase 1 trial, NCT02273960, titled Study to Evaluate Safety and Efficacy in Adult Subjects With ITP. The trial enrolled 46 adults with immune thrombocytopenic purpura across the United States, Australia, Canada, Georgia, Moldova, Poland, Russia, and the United Kingdom.