Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: BMS-986004 75 mg IV; Drug: BMS-986004 225 mg IV; Drug: BMS-986004 1500 mg IV; Drug: BMS-986004 675 mg IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273960

IM140-103

2014-001429-33 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

Arm A: BMS-986004

Experimental group

Description:

BMS-986004 solution intravenously (IV) as specified

Treatment:

Drug: BMS-986004 75 mg IV

Arm B: BMS-986004

Experimental group

Description:

BMS-986004 solution intravenously as specified

Treatment:

Drug: BMS-986004 225 mg IV

Arm C: BMS-986004

Experimental group

Description:

BMS-986004 solution intravenously as specified

Treatment:

Drug: BMS-986004 675 mg IV

Arm D: BMS-986004

Experimental group

Description:

BMS-986004 solution intravenously as specified

Treatment:

Drug: BMS-986004 1500 mg IV