NCT04055909

Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock

Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Inotrem · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

Detailed description

All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock. After screening for eligibility, patients meeting all inclusion and no exclusion criterion will be randomized. Patients will be randomized to one of three treatment arms. Treatment with study drug must be initiated as early as possible, but no later than 24 hours after the onset of septic shock, defined by the start of vasopressor therapy. Patients will be treated for at least 3 days with study drug. After the first 3 days of treatment, patients still requiring vasopressor will be treated until 24 hours after vasopressor withdrawal with a maximum treatment duration of 5 days. Patients will be assessed at the End of Study (EoS) visit at day 28. After the last patient's day 28 visit, the study will be analyzed. Additional follow up (FU) visits will be conducted after 90 days, 6 and 12 months. The objective of the study ist to compare the safety, tolerability and efficacy of two doses of nangibotide versus placebo, when given in addition to standard of care.

Conditions

• Shock, Septic

Interventions

Type	Name	Description
DRUG	nangibotide low dose	nangibotide 0.3 mg/kg/h
DRUG	nangibotide high dose	nangibotide 1.0 mg/kg/h
DRUG	placebo	matching placebo

Timeline

• Start date: 2019-11-13
• Primary completion: 2022-05-09
• Completion: 2023-05-09
• First posted: 2019-08-14
• Last updated: 2023-04-11

Locations

43 sites across 6 countries: Belgium, Denmark, Finland, France, Ireland, Spain

Regulatory

• FDA-regulated drug study