A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03017547
• Other study ID #: AACTT01
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2019
• Est. completion date: June 2020

Study information

• Verified date: May 2018
• Source: Implicit Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• IC14
Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS

Other:
• Placebo
sterile normal saline for infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Implicit Bioscience

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The number of toxicities and adverse events that are attributable to treatment. The safety parameters will include an evaluation of the clinical signs and symptoms from the history and physical exam, vital signs, adverse events, and laboratory findings. Immunogenicity studies will measure antibodies against IC14.	28 days
Primary	Ventilator-free days	The number of days alive and free of mechanical ventilation through Day 28.	28 days
Secondary	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	28 days