Phase 2 N=49 Randomized Quadruple-blind Treatment

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock

Shock, Septic

Bottom Line

View on ClinicalTrials.gov: NCT03158948 ↗

Enrolled (actual)

Serious AEs

34.7%

Results posted

Oct 2024

Primary outcome: Primary: Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion — 12; 12; 11; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nangibotide 0.3 mg/kg (Drug); Placebo (Drug); Nangibotide 1 mg/kg (Drug); Nangibotide 3 mg/kg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Inotrem
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion	12; 12; 11; 10	—
PRIMARY Systolic Blood Pressure (SBP)	121.5; 110.0; 121.0; 111.0; 114.5; 117.0	—
PRIMARY Diastolic Blood Pressure (DBP)	53.5; 55.0; 59.0; 55.5; 59.0; 55.0	—
PRIMARY Median Arterial Pressure (MAP)	72.0; 71.0; 78.0; 73.0; 77.5; 76.0	—
PRIMARY Heart Rate	83.5; 94.0; 104.5; 97.5; 89.0; 86.0	—
PRIMARY Temperature	37.3; 36.8; 37.0; 37.0; 36.3; 36.2	—
PRIMARY Electrocardiogram	4; 1; 4; 5; 3; 4	—
PRIMARY Anti-Drug Antibodies (ADA Dimer)	0; 0; 0; 0; 12; 13	—
PRIMARY Anti-Drug Antibodies (ADA Monomer)	0; 0; 0; 0; 12; 13	—
SECONDARY Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax	71.2; 234; 914	—
SECONDARY Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax	22.7; 25.4; 36.0	—
SECONDARY Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last	1722; 7579; 47320	—
SECONDARY Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg	67.6; 223; 729	—
SECONDARY Pharmacokinetic Parameters From the Non-compartmental Analysis: CL	4.52; 4.50; 4.12	—

Summary

This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.

Eligibility Criteria

Inclusion Criteria

Provide written informed consent (proxy/legal representative) according to local regulations
Age 18 to 80 years
Documented or suspected infection: lung, abdominal or elderly UTI (≥65 years)
Organ dysfunction defined as acute change in SOFA score ≥ 2 points
Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours
Hyperlactatemia (blood lactate >2 mmol/L or 18 mg/dL). This criterion must be met at least once for the purpose of diagnosis within the 24 hours before study drug administration

Exclusion Criteria: -

Previous episode of septic shock (vasopressor administration) within current hospital stay
Underlying concurrent immunodepression (specified in appendix 2)
Solid organ transplant requiring immunosuppressive therapy
Known pregnancy (positive serum pregnancy test)
Prolonged QT syndrome (QTc ≥ 440 ms)
Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
Ongoing documented or suspected endocarditis, history of prosthetic heart valves
End-stage neurological disease
End-stage cirrhosis (Child Pugh Class C)
Acute Physiology And Chronic Health Evaluation (APACHE) II score ≥ 34
End stage chronic renal disease requiring chronic dialysis
Home oxygen therapy on a regular basis for > 6 h/day
Severe obesity (BMI ≥ 40)
Recent CPR (within current hospital stay)
Moribund patients
Decision to limit full care taken before obtaining informed consent
Participation in another interventional study in the 3 months prior to randomisation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03158948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.