Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Severe Sepsis; Septic Shock

Treatments: Biological: BMS-936559; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576457

AI471-049

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.

Enrollment: 35 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:

• Severe sepsis or septic shock for at least 24 hours
• Documented or suspected infection
• Sepsis-induced immunosuppression
• Men and women ≥ 18 years old

Exclusion Criteria:

• Autoimmune disease
• Organ transplant or bone marrow transplant
• Cancer treated in the past 6 months
• Hepatitis B virus (HBV) Infection
• Human Immunodeficiency Virus (HIV) infection and not on therapy prior to this episode of sepsis
• Hepatitis C virus (HCV) infection and still has virus (not cured)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups

BMS-936559

Experimental group

Description:

BMS-936559 Intravenous infusion on specified days

Treatment:

Biological: BMS-936559

Placebo

Other group

Description:

Placebo on specified days

Treatment:

Other: Placebo