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Trial record 1 of 1 for:    Phase 1b/2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Subjects with Severe Sepsis
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Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

This study has been terminated.
(Business Objectives Have Changed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02576457
First Posted: October 15, 2015
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
October 13, 2015
October 15, 2015
September 15, 2017
December 2, 2015
March 15, 2017   (Final data collection date for primary outcome measure)
  • 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 [ Time Frame: Approximately 3 months ]
    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
  • Part 1: Tolerability of BMS-936559 in subjects with severe sepsis [ Time Frame: Approximately 3 months ]
    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
  • Part 2: All-cause mortality within 90 days of study drug administration [ Time Frame: Approximately 3 months ]
  • 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 [ Time Frame: Approximately 3 years ]
    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
  • Part 1: Tolerability of BMS-936559 in subjects with severe sepsis [ Time Frame: Approximately 3 years ]
    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
  • Part 2: All-cause mortality within 90 days of study drug administration [ Time Frame: Approximately 3 years ]
Complete list of historical versions of study NCT02576457 on ClinicalTrials.gov Archive Site
  • Maximum observed serum concentration (Cmax) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Time of maximum observed serum concentration (Tmax) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Total Body Clearance (CLT) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Volume of distribution at steady state (Vss) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Terminal serum half-life (T-HALF) of BMS-936559 [ Time Frame: Approximately 3 months ]
  • Receptor occupancy based on PD-L1 receptor occupancy levels [ Time Frame: Approximately 3 months ]
  • Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints [ Time Frame: Approximately 3 months ]
  • Immune system function based on absolute lymphocyte counts at planned sampling timepoints [ Time Frame: Approximately 3 months ]
  • Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints [ Time Frame: Approximately 3 months ]
  • Organ dysfunction measured by organ support-free days (OSFDs) [ Time Frame: Approximately 3 months ]
    OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
  • Organ dysfunction measured by proportion of OSFDs during index hospitalization [ Time Frame: Approximately 3 months ]
    OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
  • Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization [ Time Frame: Approximately 3 months ]
  • Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 [ Time Frame: Approximately 3 months ]
  • All-cause mortality at 28 days, 90 days, and 1 year after study drug administration [ Time Frame: Approximately 3 months ]

    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.

  • Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 months ]
  • Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 months ]
  • Maximum observed serum concentration (Cmax) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Time of maximum observed serum concentration (Tmax) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Total Body Clearance (CLT) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Volume of distribution at steady state (Vss) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Terminal serum half-life (T-HALF) of BMS-936559 [ Time Frame: Approximately 3 years ]
  • Receptor occupancy based on PD-L1 receptor occupancy levels [ Time Frame: Approximately 3 years ]
  • Immune system function based on baseline and post-dosing assessments of mHLA-DR expression on monocytes at planned sampling timepoints [ Time Frame: Approximately 3 years ]
  • Immune system function based on absolute lymphocyte counts at planned sampling timepoints [ Time Frame: Approximately 3 years ]
  • Immune system function based on lipopolysaccharide (LPS)-induced whole blood TNFalpha production levels at planned sampling timepoints [ Time Frame: Approximately 3 years ]
  • Organ dysfunction measured by organ support-free days (OSFDs) [ Time Frame: Approximately 3 years ]
    OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
  • Organ dysfunction measured by proportion of OSFDs during index hospitalization [ Time Frame: Approximately 3 years ]
    OSFD is defined as the last period of organ support-free duration during the index hospitalization stay prior to discharge.
  • Duration of mechanical ventilation, vasopressor use, and/or dialysis use separately during the index hospitalization [ Time Frame: Approximately 3 years ]
  • Incidence of secondary infections (as adjudicated by a clinical committee) up to 90 days post administration of BMS-936559 [ Time Frame: Approximately 3 years ]
  • All-cause mortality at 28 days, 90 days, and 1 year after study drug administration [ Time Frame: Approximately 3 years ]

    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.

  • Immunogenicity measured by number of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 years ]
  • Immunogenicity measured by percentage of subjects having detectable anti-drug antibodies (ADA) at baseline and following administration of BMS-936559. [ Time Frame: Approximately 3 years ]
Not Provided
Not Provided
 
Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis
A Phase 1b/2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Subjects With Severe Sepsis
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
  • Biological: BMS-936559
  • Other: Placebo
  • Experimental: BMS-936559
    BMS-936559 Intravenous infusion on specified days
    Intervention: Biological: BMS-936559
  • Placebo
    Placebo on specified days
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
March 15, 2017
March 15, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02576457
AI471-049
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP