Study Stopped
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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
1 other identifier
interventional
35
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2015
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedSeptember 15, 2017
September 1, 2017
1.3 years
October 13, 2015
September 14, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Part 2: All-cause mortality within 90 days of study drug administration
Approximately 3 months
Secondary Outcomes (18)
Maximum observed serum concentration (Cmax) of BMS-936559
Approximately 3 months
Time of maximum observed serum concentration (Tmax) of BMS-936559
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
Approximately 3 months
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-936559
Approximately 3 months
Total Body Clearance (CLT) of BMS-936559
Approximately 3 months
- +13 more secondary outcomes
Study Arms (2)
BMS-936559
EXPERIMENTALBMS-936559 Intravenous infusion on specified days
Placebo
OTHERPlacebo on specified days
Interventions
Eligibility Criteria
You may qualify if:
- Severe sepsis or septic shock for at least 24 hours
- Documented or suspected infection
- Sepsis-induced immunosuppression
- Men and women ≥ 18 years old
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Uc Davis Medical Center
Sacramento, California, 95817, United States
Local Institution
Denver, Colorado, 80204, United States
University Of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
Osf Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan, Division of Acute Care Surgery
Ann Arbor, Michigan, 48109-5033, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
The Ohio State University
Columbus, Ohio, 43210, United States
St. Vincent'S Medical Center
Toledo, Ohio, 43603, United States
UPMC
Pittsburgh, Pennsylvania, 15261-2500, United States
Local Institution
Seattle, Washington, 98104, United States
Related Publications (1)
Hotchkiss RS, Colston E, Yende S, Angus DC, Moldawer LL, Crouser ED, Martin GS, Coopersmith CM, Brakenridge S, Mayr FB, Park PK, Ye J, Catlett IM, Girgis IG, Grasela DM. Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559). Crit Care Med. 2019 May;47(5):632-642. doi: 10.1097/CCM.0000000000003685.
PMID: 30747773DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
December 2, 2015
Primary Completion
March 15, 2017
Study Completion
March 15, 2017
Last Updated
September 15, 2017
Record last verified: 2017-09