- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273960
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
Status
Completed
Conditions
Intervention / Treatment
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
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Local Institution
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Queensland
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Brisbane, Queensland, Australia, 4102
- Local Institution
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Hamilton Health Sciences/Mc Master Univ Med Ctre
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Tbilisi, Georgia, 0112
- Local Institution
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Chisinau, Moldova, Republic of, MD 2025
- Local Institution
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Chorzow, Poland, 41-500
- Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
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Lublin, Poland, 20-601
- Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
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Warszawa, Poland, 02-106
- Local Institution
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Saint-Petersburg, Russian Federation, 194356
- Local Institution
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Smolensk, Russian Federation
- Local Institution
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London, United Kingdom, E1 1BB
- Local Institution
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Greater London
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London, Greater London, United Kingdom, NW1 2PG
- Local Institution
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M13 9WL
- Local Institution
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Lanarkshire
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Glasgow, Lanarkshire, United Kingdom, G4 OSF
- Local Institution
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California
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Los Angeles, California, United States, 90033
- Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Columbus, Georgia, United States, 31904
- Columbus Regional Research Institute
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Mass General Hospital
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Rutgers- Robert Wood Johnson Medical School
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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 |
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Experimental: Arm A: BMS-986004
BMS-986004 solution intravenously (IV) as specified
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BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
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Experimental: Arm B: BMS-986004
BMS-986004 solution intravenously as specified
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BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
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Experimental: Arm C: BMS-986004
BMS-986004 solution intravenously as specified
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BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
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Experimental: Arm D: BMS-986004
BMS-986004 solution intravenously as specified
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BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
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Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
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Number of ECG Abnormalities
Time Frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
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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)
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Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
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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)
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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.
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Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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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.
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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)
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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)
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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.
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- IM140-103
- 2014-001429-33 (EudraCT Number)
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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