Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Nov 2014

Typical duration for phase_1

Geographic Reach

8 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

October 3, 2014

Completed

21 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed

24 days until next milestone

Study Start

First participant enrolled

November 17, 2014

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

April 1, 2019

Completed

Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

October 3, 2014

Results QC Date

January 17, 2019

Last Update Submit

July 15, 2019

Conditions

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (3)

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)
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)
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 Outcomes (6)

Response Rate (RR) of BMS-986004: Short Term and Long Term
Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Maximum Observed Serum Concentration (Cmax) of BMS-986004
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
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
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
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)
+1 more secondary outcomes

Study Arms (4)

Arm A: BMS-986004

EXPERIMENTAL

BMS-986004 solution intravenously (IV) as specified

Drug: BMS-986004 75 mg IV

Arm B: BMS-986004

EXPERIMENTAL

BMS-986004 solution intravenously as specified

Drug: BMS-986004 225 mg IV

Arm C: BMS-986004

EXPERIMENTAL

BMS-986004 solution intravenously as specified

Drug: BMS-986004 675 mg IV

Arm D: BMS-986004

EXPERIMENTAL

BMS-986004 solution intravenously as specified

Drug: BMS-986004 1500 mg IV

Interventions

BMS-986004 75 mg IVDRUG

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

Arm A: BMS-986004

BMS-986004 225 mg IVDRUG

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

Arm B: BMS-986004

BMS-986004 675 mg IVDRUG

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

Arm C: BMS-986004

BMS-986004 1500 mg IVDRUG

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

Arm D: BMS-986004

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥18 years old, diagnosed with persistent or chronic ITP

You may not qualify if:

Secondary immune thrombocytopenia
Drug induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bristol-Myers Squibblead

Study Sites (20)

Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Rutgers- Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Local Institution

Randwick, New South Wales, 2031, Australia

Location

Local Institution

Brisbane, Queensland, 4102, Australia

Location

Hamilton Health Sciences/Mc Master Univ Med Ctre

Hamilton, Ontario, L8S 4K1, Canada

Location

Local Institution

Tbilisi, 0112, Georgia

Location

Local Institution

Chisinau, MD 2025, Moldova

Location

Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

Chorzów, 41-500, Poland

Location

Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos

Lublin, 20-601, Poland

Location

Local Institution

Warsaw, 02-106, Poland

Location

Local Institution

Saint Petersburg, 194356, Russia

Location

Local Institution

Smolensk, Russia

Location

Local Institution

London, Greater London, NW1 2PG, United Kingdom

Location

Local Institution

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Local Institution

Glasgow, Lanarkshire, G4 OSF, United Kingdom

Location

Local Institution

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb

Study Officials

Bristol-Myers Squibb
Bristol-Myers Squibb
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 24, 2014

Study Start

November 17, 2014

Primary Completion

January 22, 2018

Study Completion

January 22, 2018

Last Updated

July 16, 2019

Results First Posted

April 1, 2019

Record last verified: 2019-07

Locations

PL(3)GB(4)MO(1)RU(2)GE(1)CA(1)US(6)AU(2)

Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (4)

Arm A: BMS-986004

Arm B: BMS-986004

Arm C: BMS-986004

Arm D: BMS-986004

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (4)

Arm A: BMS-986004

Arm B: BMS-986004

Arm C: BMS-986004

Arm D: BMS-986004

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations