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 an investigational small molecule being studied for the treatment of Immune Thrombocytopenic Purpura (ITP), a hematologic condition. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently 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 drug is an investigational small molecule in Phase 1 clinical development for Immune Thrombocytopenic Purpura.
BMS-986004 is in Phase 1 clinical development. It is an investigational small molecule being studied for Immune Thrombocytopenic Purpura. The drug is not approved and remains in clinical testing.
BMS-986004 has one completed Phase 1 clinical trial, NCT02273960, which evaluated safety and efficacy in adult subjects with Immune Thrombocytopenic Purpura. The trial enrolled 46 participants across the United States, Australia, Canada, Georgia, Moldova, Poland, Russia, and the United Kingdom.
No alternative names for BMS-986004 have been disclosed. The drug is identified solely by its code name BMS-986004 and is being developed by Bristol-Myers Squibb Company for Immune Thrombocytopenic Purpura.