A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

NCT03017547 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: AACTT01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Safety

  Treatment-emergent adverse events

  28 days

• Ventilator-free days

  The number of days alive and free of mechanical ventilation through Day 28.

  28 days

Secondary Outcomes (1)

• Change in ARDS biologic markers.

  28 days

Study Arms (2)

IC14

EXPERIMENTAL

IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4.

Drug: IC14

Placebo

PLACEBO COMPARATOR

Placebo IV once daily on Study Day 1-4

Other: Placebo

Interventions

IC14 DRUG

Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS

Also known as: monoclonal antibody against CD14

IC14

Placebo OTHER

sterile normal saline for infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU admission
• Age 18-70 years
• Presence of a known ARDS clinical risk within 7 days of onset:
• Pneumonia
• Sepsis
• Trauma
• Aspiration
• Pancreatitis
• Presence of ARDS (per Berlin criteria) defined as follows:
• Acute onset (\<48 hours)
• PaO2/FiO2\<300 on PEEP≥5
• Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
• Requirement for positive pressure ventilation via endotracheal tube
• Anticipated duration of mechanical ventilation \>48 hrs

You may not qualify if:

• Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
• Intubation for cardiopulmonary arrest
• Do-not-attempt resuscitation (DNAR) status
• Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
• Anticipated survival \<48 hours from intubation
• Anticipated survival \<28 days due to pre-existing medical condition
• Significant pre-existing organ dysfunction
• Lung: Currently receiving home oxygen therapy as documented in medical record
• Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
• Renal: Chronic renal failure requiring renal replacement therapy
• Liver: Severe chronic liver disease defined as Child-Pugh Class C
• Pre-existing, ongoing immunosuppression
• Solid organ transplant recipient
• Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days)
• Oncolytic drug therapy within the past 14 days

Sponsors & Collaborators

• Implicit Bioscience: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jan Agosti, MD

  Implicit Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 5, 2026

Record last verified: 2018-05