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

Primary Purpose

Shock, Septic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MOTREM

Placebo

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring Sepsis, LR12, TREM1, TREM-1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques Universitaires Saint-Luc (there may be other sites in this country)
Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)
Radboudumc (there may be other sites in this country)
Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

MOTREM 1

MOTREM 2

MOTREM 3

Placebo

Arm Description

0.3 mg/kg/h

1.0 mg/kg/h

3.0 mg/kg/h

Outcomes

Primary Outcome Measures

Vital signs

systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)

ECG

12-lead ECG

Number of patients with clinically relevant abnormal laboratory values

Laboratory tests related to hematology, biochemistry and coagulation

Presence of anti-LR12 antibodies

Number of patients with anti-LR12 anti drug antibodies

Adverse events

Number of patients with adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT03158948

First Posted

May 16, 2017

Last Updated

June 20, 2018

Sponsor

Inotrem

1. Study Identification

Unique Protocol Identification Number

NCT03158948

Brief Title

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

Official Title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

July 3, 2017 (Actual)

Primary Completion Date

June 13, 2018 (Actual)

Study Completion Date

June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inotrem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 MOTREM versus placebo in adult patients with septic shock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Septic

Keywords

Sepsis, LR12, TREM1, TREM-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomised, Double-blind, Two-Stage, Placebo Controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MOTREM 1

Arm Type

Experimental

Arm Description

0.3 mg/kg/h

Arm Title

MOTREM 2

Arm Type

Experimental

Arm Description

1.0 mg/kg/h

Arm Title

MOTREM 3

Arm Type

Experimental

Arm Description

3.0 mg/kg/h

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MOTREM

Intervention Description

Formulated LR12 peptide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Vital signs

Description

systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)

Time Frame

28 days

Title

ECG

Description

12-lead ECG

Time Frame

28 days

Title

Number of patients with clinically relevant abnormal laboratory values

Description

Laboratory tests related to hematology, biochemistry and coagulation

Time Frame

28 days

Title

Presence of anti-LR12 antibodies

Description

Number of patients with anti-LR12 anti drug antibodies

Time Frame

28 days

Title

Adverse events

Description

Number of patients with adverse events

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno François, MD

Organizational Affiliation

Inserm 1435 Clinical Investigational Center, Limoges, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires Saint-Luc (there may be other sites in this country)

City

Brussels

Country

Belgium

Facility Name

Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)

City

Limoges Cedex

Country

France

Facility Name

Radboudumc (there may be other sites in this country)

City

Nijmegen

Country

Netherlands

Facility Name

Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)

City

Madrid

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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