Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

Immune Thrombocytopenic Purpura Clinical Trial

— ITP  

Official title:

Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273960
• Other study ID #: IM140-103
• Secondary ID: 2014-001429-33
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 17, 2014
• Est. completion date: January 22, 2018

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• BMS-986004 75 mg IV
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
• BMS-986004 225 mg IV
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
• BMS-986004 675 mg IV
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
• BMS-986004 1500 mg IV
BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

Locations

Country	Name	City	State
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Randwick	New South Wales
Canada	Hamilton Health Sciences/Mc Master Univ Med Ctre	Hamilton	Ontario
Georgia	Local Institution	Tbilisi
Moldova, Republic of	Local Institution	Chisinau
Poland	Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych	Chorzow
Poland	Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos	Lublin
Poland	Local Institution	Warszawa
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Smolensk
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	Emory University	Atlanta	Georgia
United States	Mass General Hospital	Boston	Massachusetts
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Univ. Of Southern Calif. /Norris Comprehensive Cancer Center	Los Angeles	California
United States	Rutgers- Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Georgia,  Moldova, Republic of,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term	The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods	Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Primary	Number of ECG Abnormalities	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)	Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Primary	Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)	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.	Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
Secondary	Response Rate (RR) of BMS-986004: Short Term and Long Term	Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count = 100,000/mm3 and absence of bleeding. R was defined as platelet count = 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding.	Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Secondary	Maximum Observed Serum Concentration (Cmax) of BMS-986004	Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.	Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Secondary	Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004	Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.	Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Secondary	Trough Observed Serum Concentration (Ctrough) of BMS-986004	Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.	Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Secondary	Total Body Clearance (CLT) of BMS-986004	Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.	Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Secondary	AUC Accumulation Index (AI_AUC) of BMS-986004	AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.	Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form