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Study · Randomized controlled trial · n = 49 · 2020

9 results

Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.

François B, Wittebole X, Ferrer R, Mira JP, Dugernier T, Gibot S, Derive M, Olivier A, Cuvier V, Witte S, Pickkers P, Vandenhende F and 4 more

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Garaud JJ, Sánchez M, Salcedo-Magguilli M, Laterre PF

Intensive care medicine28 May 2020Cited by 59 (Europe PMC)

PMID32468087 (opens in a new tab)DOI10.1007/s00134-020-06109-z (opens in a new tab)PepBankPUB-32468087
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In septic shock patients, treatment-emergent adverse events did not differ significantly between nangibotide and placebo groups.

    In plain wordsIn septic shock patients, adverse events did not differ significantly between nangibotide and placebo groups.

    Peptide
    Nangibotide
    Outcome
    No significant changeTreatment-emergent adverse events
    Study

    n = 49

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    No significant differences were observed in TEAEs between treatment groups.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In septic shock patients, pooled nangibotide groups had a non-significant SOFA score difference of -0.7 versus placebo at Day 5.

    In plain wordsIn septic shock patients, SOFA score change did not differ significantly between pooled nangibotide groups and placebo.

    Peptide
    Nangibotide
    Outcome
    No significant changeSOFA score change in randomized population
    Study

    n = 49

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Overall treatment effect · Whole body
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Measurements

    SOFA score LS mean change difference
    −0.7 points
    randomized population
    Standard error
    0.85 points
    randomized population

    Source sentences

    Summary
    Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant).
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  3. 03HumanRandomized controlled trialActivity measurement

    In septic shock patients, nangibotide did not significantly affect pharmacodynamic markers.

    In plain wordsIn septic shock patients, nangibotide did not significantly affect pharmacodynamic markers.

    Peptide
    Nangibotide
    Outcome
    No significant changePharmacodynamic markers
    Study

    n: not reported in source

    Analysis
    Exploratory
    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    Nangibotide did not significantly affect pharmacodynamic markers.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In septic shock patients with high baseline sTREM-1, pooled nangibotide groups had a non-significant SOFA score difference of -1.5 versus placebo.

    In plain wordsIn patients with high baseline sTREM-1, SOFA score change did not differ significantly between pooled nangibotide groups and placebo.

    Peptide
    Nangibotide
    Outcome
    No significant changeSOFA score change with high baseline sTREM-1
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Overall treatment effect · Whole body
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Measurements

    SOFA score LS mean change difference
    −1.5 points
    high baseline plasma sTREM-1
    Standard error
    1.12 points
    high baseline plasma sTREM-1

    Source sentences

    Summary
    Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant).
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In septic shock patients, organ support endpoints showed a pattern similar to the SOFA score change with pooled nangibotide versus placebo. The source does not state significance for these endpoints.

    In plain wordsIn septic shock patients, organ support outcomes showed a pattern similar to the SOFA score change with nangibotide versus placebo. Significance was not stated.

    Peptide
    Nangibotide
    Outcome
    Direction not reportedOrgan support endpoints
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Overall treatment effect · Whole body
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    This pattern was similar to organ support end points.
    3 context sentences
    Summary · context
    Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant).
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  6. 06HumanRandomized controlled trialSafety outcome

    In septic shock patients, no withdrawal linked to treatment-emergent adverse events was reported with nangibotide.

    In plain wordsIn septic shock patients, no withdrawal linked to adverse events was reported with nangibotide.

    Peptide
    Nangibotide
    Outcome
    Not applicableWithdrawal due to adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  7. 07HumanRandomized controlled trialSafety outcome

    In septic shock patients, no appearance of anti-drug antibodies was reported with nangibotide.

    In plain wordsIn septic shock patients, no anti-drug antibodies were reported with nangibotide.

    Peptide
    Nangibotide
    Outcome
    Not applicableAnti-drug antibodies
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  8. 08HumanRandomized controlled trialPharmacokinetics

    In septic shock patients, nangibotide pharmacokinetics appeared dose-proportional.

    In plain wordsIn septic shock patients, nangibotide exposure appeared proportional to dose.

    Peptide
    Nangibotide
    Outcome
    Not applicableDose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.
  9. 09HumanRandomized controlled trialPharmacokinetics

    In septic shock patients, nangibotide clearance was dose-independent.

    In plain wordsIn septic shock patients, nangibotide clearance did not depend on dose.

    Peptide
    Nangibotide
    Outcome
    Not applicableDose independence of clearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.3, 1.0, or 3.0 mg/kg/h · continuous infusion · up to 5 daysAs given in this study (human).

    Source sentences

    Summary
    Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent.
    2 context sentences
    Summary · context
    This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.MethodsThis was a multicenter randomized, double-blind, two-stage study.
    Summary · context
    Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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