A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Implicit Bioscience

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Acute Respiratory Distress Syndrome

Interventions

IC14DRUG

Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS

PlaceboOTHER

sterile normal saline for infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ICU admission 2. Age 18-70 years 3. Presence of a known ARDS clinical risk within 7 days of onset: 1. Pneumonia 2. Sepsis 3. Trauma 4. Aspiration 5. Pancreatitis 4. Presence of ARDS (per Berlin criteria) defined as follows: 1. Acute onset (\<48 hours) 2. PaO2/FiO2\<300 on PEEP≥5 3. Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules. 4. Requirement for positive pressure ventilation via endotracheal tube 5. Anticipated duration of mechanical ventilation \>48 hrs Exclusion Criteria: 1. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry 2. Intubation for cardiopulmonary arrest 3. Do-not-attempt resuscitation (DNAR) status 4. Intubation for status asthmaticus, pulmonary embolus, myocardial infarction 5. Anticipated survival \<48 hours from intubation 6. Anticipated survival \<28 days due to pre-existing medical condition 7. Significant pre-existing organ dysfunction 1. Lung: Currently receiving home oxygen therapy as documented in medical record 2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record 3. Renal: Chronic renal failure requiring renal replacement therapy 4. Liver: Severe chronic liver disease defined as Child-Pugh Class C 8. Pre-existing, ongoing immunosuppression 1. Solid organ transplant recipient 2. Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days) 3. Oncolytic drug therapy within the past 14 days 4. Known HIV positive with CD4 count \<200 cells/mm3 9. Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept) 10. Pregnancy 11. History of hypersensitivity or idiosyncratic reaction to IC14 12. Deprivation of freedom by administrative or court order

Outcomes

Primary Outcomes

Safety

Treatment-emergent adverse events

Time frame: 28 days

Ventilator-free days

The number of days alive and free of mechanical ventilation through Day 28.

Time frame: 28 days

Secondary Outcomes

Change in ARDS biologic markers.

* Change in plasma IL-8, sTNFR1, IL-6 from Day 0 to Day 4 * Change in alveolar neutrophils and total protein from Day 0 to Day 4

Time frame: 28 days

Data from ClinicalTrials.gov

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