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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02576457
Other study ID # AI471-049
Secondary ID
Status Terminated
Phase Phase 1
First received October 13, 2015
Last updated September 14, 2017
Start date December 2, 2015
Est. completion date March 15, 2017

Study information

Verified date September 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 35
Est. completion date March 15, 2017
Est. primary completion date March 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BMS-936559

Other:
Placebo


Locations

Country Name City State
United States University of Michigan, Division of Acute Care Surgery Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States The Ohio State University Columbus Ohio
United States Local Institution Denver Colorado
United States University Of Florida Gainesville Florida
United States Osf Saint Francis Medical Center Peoria Illinois
United States UPMC Pittsburgh Pennsylvania
United States Uc Davis Medical Center Sacramento California
United States Washington University School Of Medicine Saint Louis Missouri
United States Local Institution Seattle Washington
United States Baystate Medical Center Springfield Massachusetts
United States St. Vincent'S Medical Center Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Safety of BMS-936559 in subjects with severe sepsis - measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest and laboratory abnormalities Safety will be measured by the incidence rates of death, Adverse event (AEs), Serious adverse event (SAEs), AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities Approximately 3 months
Primary Part 1: Tolerability of BMS-936559 in subjects with severe sepsis Tolerability will be measured by the incidence rates of death, AEs, SAEs, AEs leading to discontinuation, AEs of special interest (identified from PD-L1 oncology trial), and laboratory abnormalities Approximately 3 months
Primary Part 2: All-cause mortality within 90 days of study drug administration Approximately 3 months
Secondary Maximum observed serum concentration (Cmax) of BMS-936559 Approximately 3 months
Secondary Time of maximum observed serum concentration (Tmax) of BMS-936559 Approximately 3 months
Secondary Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 Approximately 3 months
Secondary Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 Approximately 3 months
Secondary Total Body Clearance (CLT) of BMS-936559 Approximately 3 months
Secondary Volume of distribution at steady state (Vss) of BMS-936559 Approximately 3 months
Secondary Terminal serum half-life (T-HALF) of BMS-936559 Approximately 3 months
Secondary Receptor occupancy based on PD-L1 receptor occupancy levels Approximately 3 months
Secondary Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints Approximately 3 months
Secondary Immune system function based on absolute lymphocyte counts at planned sampling timepoints Approximately 3 months
Secondary Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints Approximately 3 months
Secondary Organ dysfunction measured by organ support-free days (OSFDs) OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. Approximately 3 months
Secondary Organ dysfunction measured by proportion of OSFDs during index hospitalization OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge. Approximately 3 months
Secondary Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization Approximately 3 months
Secondary Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 Approximately 3 months
Secondary All-cause mortality at 28 days, 90 days, and 1 year after study drug administration All-cause mortality at 28 days, 90 days, and 1 year post administration of BMS-936559.
Time to death will also be used to assess the treatment effect.
Approximately 3 months
Secondary Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. Approximately 3 months
Secondary Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. Approximately 3 months
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