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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: IC14; Other: Placebo

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IC14; IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4.	Drug: IC14; Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS; Other Names: monoclonal antibody against CD14
Placebo Comparator: Placebo; Placebo IV once daily on Study Day 1-4	Other: Placebo; sterile normal saline for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-free days	The number of days alive and free of mechanical ventilation through Day 28.	28 days
Safety	Treatment-emergent adverse events	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Implicit Bioscience
• Investigators: Study Director: Jan Agosti, MD, Implicit Bioscience

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2019
• Primary Completion (Estimated): June 1, 2020
• Study Completion (Estimated): June 1, 2020

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimated): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Immunologic Factors; Physiological Effects of Drugs; Antibodies, Monoclonal
• Other Study ID Numbers: AACTT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No