Study to Evaluate Safety and Efficacy in Adult Subjects With ITP - Clinical Trial for Immune Thrombocytopenic Purpura | NCT02273960

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-986004 75 mg IV

BMS-986004 225 mg IV

BMS-986004 675 mg IV

BMS-986004 1500 mg IV

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Georgetown University Medical Center
Emory University
Columbus Regional Research Institute
Mass General Hospital
Rutgers- Robert Wood Johnson Medical School
Local Institution
Local Institution
Hamilton Health Sciences/Mc Master Univ Med Ctre
Local Institution
Local Institution
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm A: BMS-986004

Arm B: BMS-986004

Arm C: BMS-986004

Arm D: BMS-986004

Arm Description

BMS-986004 solution intravenously (IV) as specified

BMS-986004 solution intravenously as specified

Outcomes

Primary Outcome Measures

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

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)

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02273960

First Posted

October 3, 2014

Last Updated

July 15, 2019

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02273960

Brief Title

Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 17, 2014 (Actual)

Primary Completion Date

January 22, 2018 (Actual)

Study Completion Date

January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: BMS-986004

Arm Type

Experimental

Arm Description

BMS-986004 solution intravenously (IV) as specified

Arm Title

Arm B: BMS-986004

Arm Type

Experimental

Arm Description

BMS-986004 solution intravenously as specified

Arm Title

Arm C: BMS-986004

Arm Type

Experimental

Arm Description

BMS-986004 solution intravenously as specified

Arm Title

Arm D: BMS-986004

Arm Type

Experimental

Arm Description

BMS-986004 solution intravenously as specified

Intervention Type

Drug

Intervention Name(s)

BMS-986004 75 mg IV

Intervention Description

BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes

Intervention Type

Drug

Intervention Name(s)

BMS-986004 225 mg IV

Intervention Description

BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes

Intervention Type

Drug

Intervention Name(s)

BMS-986004 675 mg IV

Intervention Description

BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes

Intervention Type

Drug

Intervention Name(s)

BMS-986004 1500 mg IV

Intervention Description

BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term

Description

The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods

Time Frame

Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)

Title

Number of ECG Abnormalities

Description

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)

Time Frame

Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)

Title

Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)

Description

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.

Time Frame

Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)

Secondary Outcome Measure Information:

Title

Response Rate (RR) of BMS-986004: Short Term and Long Term

Description

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.

Time Frame

Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)

Title

Maximum Observed Serum Concentration (Cmax) of BMS-986004

Description

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.

Time Frame