Trial | NCT03017547  Report issue

Title

A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    ic14 ...

  • Study Participants

    0
Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.
Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.
Study Started
Jun 30
2019
Anticipated
Primary Completion
Jun 30
2020
Anticipated
Study Completion
Jun 30
2020
Anticipated
Last Update
Mar 14
2019

Drug IC14

Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS

  • Other names: monoclonal antibody against CD14

Other Placebo

sterile normal saline for infusion

IC14 Experimental

IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4.

Placebo Placebo Comparator

Placebo IV once daily on Study Day 1-4

Criteria 

Inclusion Criteria:

ICU admission
Age 18-70 years

Presence of a known ARDS clinical risk within 7 days of onset:

Pneumonia
Sepsis
Trauma
Aspiration
Pancreatitis

Presence of ARDS (per Berlin criteria) defined as follows:

Acute onset (<48 hours)
PaO2/FiO2<300 on PEEP≥5
Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
Requirement for positive pressure ventilation via endotracheal tube
Anticipated duration of mechanical ventilation >48 hrs

Exclusion Criteria:

Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
Intubation for cardiopulmonary arrest
Do-not-attempt resuscitation (DNAR) status
Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
Anticipated survival <48 hours from intubation
Anticipated survival <28 days due to pre-existing medical condition

Significant pre-existing organ dysfunction

Lung: Currently receiving home oxygen therapy as documented in medical record
Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
Renal: Chronic renal failure requiring renal replacement therapy
Liver: Severe chronic liver disease defined as Child-Pugh Class C

Pre-existing, ongoing immunosuppression

Solid organ transplant recipient
Chronic high-dose corticosteroids (equivalent to >20 mg/prednisone/day for >14 days in the last 30 days)
Oncolytic drug therapy within the past 14 days
Known HIV positive with CD4 count <200 cells/mm3
Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)
Pregnancy
History of hypersensitivity or idiosyncratic reaction to IC14
Deprivation of freedom by administrative or court order
No Results Posted