Clinical Trial: A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Implicit Bioscience

Current Primary Outcome:

• Safety [ Time Frame: 28 days ]
  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.
• Ventilator-free days [ Time Frame: 28 days ]
  The number of days alive and free of mechanical ventilation through Day 28.

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in ARDS biologic markers. [ Time Frame: 28 days ]

Original Secondary Outcome: Same as current

Information By: Implicit Bioscience

Dates:
Date Received: January 9, 2017
Date Started: June 2017
Date Completion: June 2020
Last Updated: January 13, 2017
Last Verified: January 2017