Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)

July 15, 2019 updated by: Bristol-Myers Squibb

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Hamilton Health Sciences/Mc Master Univ Med Ctre
      • Tbilisi, Georgia, 0112
        • Local Institution
      • Chisinau, Moldova, Republic of, MD 2025
        • Local Institution
      • Chorzow, Poland, 41-500
        • Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
      • Lublin, Poland, 20-601
        • Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
      • Warszawa, Poland, 02-106
        • Local Institution
      • Saint-Petersburg, Russian Federation, 194356
        • Local Institution
      • Smolensk, Russian Federation
        • Local Institution
      • London, United Kingdom, E1 1BB
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, NW1 2PG
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G4 OSF
        • Local Institution
    • California
      • Los Angeles, California, United States, 90033
        • Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers- Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: BMS-986004
BMS-986004 solution intravenously (IV) as specified
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
Experimental: Arm B: BMS-986004
BMS-986004 solution intravenously as specified
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
Experimental: Arm C: BMS-986004
BMS-986004 solution intravenously as specified
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
Experimental: Arm D: BMS-986004
BMS-986004 solution intravenously as specified
BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (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)
Number of ECG Abnormalities
Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
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)
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (RR) of BMS-986004: Short Term and Long Term
Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (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)
Maximum Observed Serum Concentration (Cmax) of BMS-986004
Time Frame: 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)
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)
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
Time Frame: 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)
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)
Trough Observed Serum Concentration (Ctrough) of BMS-986004
Time Frame: 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)
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)
Total Body Clearance (CLT) of BMS-986004
Time Frame: 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)
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)
AUC Accumulation Index (AI_AUC) of BMS-986004
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2014

Primary Completion (Actual)

January 22, 2018

Study Completion (Actual)

January 22, 2018

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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