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

• ClinicalTrials.gov Identifier: NCT03158948
• Recruitment Status: Completed
• First Posted: May 18, 2017
• Last Update Posted: June 21, 2018
• Sponsor: Inotrem
• Information provided by (Responsible Party): Inotrem

Tracking Information

• First Submitted Date: May 16, 2017
• First Posted Date: May 18, 2017
• Last Update Posted Date: June 21, 2018
• Actual Study Start Date: July 3, 2017
• Actual Primary Completion Date: June 13, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2017)

• Vital signs [ Time Frame: 28 days ]
  systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)
• ECG [ Time Frame: 28 days ]
  12-lead ECG
• Number of patients with clinically relevant abnormal laboratory values [ Time Frame: 28 days ]
  Laboratory tests related to hematology, biochemistry and coagulation
• Presence of anti-LR12 antibodies [ Time Frame: 28 days ]
  Number of patients with anti-LR12 anti drug antibodies
• Adverse events [ Time Frame: 28 days ]
  Number of patients with adverse events

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Shock, Septic

Intervention

• Drug: MOTREM
  Formulated LR12 peptide
• Drug: Placebo
  placebo

Study Arms

• Experimental: MOTREM 1
  0.3 mg/kg/h
  Intervention: Drug: MOTREM
• Experimental: MOTREM 2
  1.0 mg/kg/h
  Intervention: Drug: MOTREM
• Experimental: MOTREM 3
  3.0 mg/kg/h
  Intervention: Drug: MOTREM
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 5, 2018): 50
• Original Estimated Enrollment (submitted: May 17, 2017): 48
• Actual Study Completion Date: June 13, 2018
• Actual Primary Completion Date: June 13, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Netherlands, Spain

Administrative Information

• NCT Number: NCT03158948
• Other Study ID Numbers: MOT-C-201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Inotrem
• Study Sponsor: Inotrem
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bruno François, MD; Inserm 1435 Clinical Investigational Center, Limoges, France

• PRS Account: Inotrem
• Verification Date: June 2018