Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02273960
Ethics application status
Date submitted
3/10/2014
Date registered
3/10/2014
Date last updated
26/09/2017

Titles & IDs
Public title
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP
Scientific 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)
Secondary ID [1] 0 0
2014-001429-33
Secondary ID [2] 0 0
IM140-103
Universal Trial Number (UTN)
Trial acronym
ITP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenic Purpura 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - BMS-986004

Experimental: Arm A: BMS-986004 - BMS-986004 solution intravenously as specified

Experimental: Arm B: BMS-986004 - BMS-986004 solution intravenously as specified

Experimental: Arm C: BMS-986004 - BMS-986004 solution intravenously as specified

Experimental: Arm D: BMS-986004 - BMS-986004 solution intravenously as specified


Treatment: drugs: BMS-986004


Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Short-Term Period: Safety measured by number of subjects with adverse events (AEs), serious adverse events (SAEs), ECG abnormalities
Timepoint [1] 0 0
Day 1 to Day 141
Primary outcome [2] 0 0
Short-Term Period: Safety measured by number of subjects with laboratory abnormalities including safety biomarkers of d-Dimer and Thrombin anti-Thrombin (TAT)
Timepoint [2] 0 0
Day 1 to Day 141
Primary outcome [3] 0 0
Long-Term Extension Period: Safety measured by number of subjects with AEs, SAEs, ECG abnormalities
Timepoint [3] 0 0
Day 1 to Day 398
Primary outcome [4] 0 0
Long-Term Extension Period: Safety measured by number of subjects with laboratory abnormalities including safety biomarkers of d-Dimer and TAT
Timepoint [4] 0 0
Day 1 to Day 398
Secondary outcome [1] 0 0
Short-Term Period: Response rate (RR) of BMS-986004 - RR is defined as the proportion of subjects who are responders.
Timepoint [1] 0 0
Day 1 to Day 141
Secondary outcome [2] 0 0
Long-Term Extension Period: Response rate (RR) of BMS-986004 - RR is defined as the proportion of subjects who are responders.
Timepoint [2] 0 0
Day 1 to Day 398
Secondary outcome [3] 0 0
Maximum observed serum concentration (Cmax) of BMS-986004
Timepoint [3] 0 0
From Day 1 till Day 141
Secondary outcome [4] 0 0
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986004
Timepoint [4] 0 0
From Day 1 till Day 141
Secondary outcome [5] 0 0
Trough observed serum concentration (Ctrough) of BMS-986004
Timepoint [5] 0 0
From Day 1 till Day 141
Secondary outcome [6] 0 0
Total body clearance (CLT) of BMS-986004
Timepoint [6] 0 0
From Day 1 till Day 141
Secondary outcome [7] 0 0
AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004
Timepoint [7] 0 0
From Day 1 till Day 141
Secondary outcome [8] 0 0
Cmax accumulation index (AI_Cmax); ratio of Cmax at steady-state to Cmax after the first dose of BMS-986004
Timepoint [8] 0 0
From Day 1 till Day 141

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- =18 years old, diagnosed with persistent or chronic ITP
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Secondary immune thrombocytopenia

- Drug induced thrombocytopenia

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - Randwick
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Georgia
State/province [7] 0 0
Tbilisi
Country [8] 0 0
Moldova, Republic of
State/province [8] 0 0
Chisinau
Country [9] 0 0
Poland
State/province [9] 0 0
Chorzow
Country [10] 0 0
Poland
State/province [10] 0 0
Lublin
Country [11] 0 0
Poland
State/province [11] 0 0
Warszawa
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Saint-Petersburg
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Smolensk
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Greater London
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Greater Manchester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Lanarkshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-986004 when
administered in subjects with ITP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information