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WITHDRAWN

NCT03017547

PHASE2

A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Sponsor: Implicit Bioscience

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-06

Completion Date

2020-06

Last Updated

2026-05-05

Healthy Volunteers

Conditions

Acute Respiratory Distress Syndrome

Interventions

DRUG

IC14

Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS

OTHER

Placebo

sterile normal saline for infusion

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