Clinical trial NCT03017547: A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Implicit Bioscience
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 28 days
measure: Ventilator-free days
timeFrame: 28 days
Secondary outcomes:
measure: Change in ARDS biologic markers.
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Implicit Bioscience
name: Jan Agosti, MD
role: STUDY_DIRECTOR
References: