Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02273960
• Date of registration: 03/10/2014
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Study to Evaluate Safety and Efficacy in Adult Subjects With ITP 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)
• Date of first enrolment: November 17, 2014
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02273960
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, Canada, Georgia, Moldova, Republic of, Poland, Russian Federation, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenic Purpura

Intervention(s)

Drug: BMS-986004 75 mg IV

Drug: BMS-986004 225 mg IV

Drug: BMS-986004 675 mg IV

Drug: BMS-986004 1500 mg IV

Primary Outcome(s)

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)]

Number of ECG Abnormalities [Time Frame: 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)]

Secondary Outcome(s)

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)]

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)]

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)]

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)]

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)]

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)]

Secondary ID(s)

IM140-103

2014-001429-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02273960