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A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Sponsor
Implicit Bioscience (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03017547
Collaborator
(none)
0
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Safety [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.

    2. Ventilator-free days [28 days]

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

    Secondary Outcome Measures

    1. Change in ARDS biologic markers. [28 days]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ICU admission

    2. Age 18-70 years

    3. Presence of a known ARDS clinical risk within 7 days of onset:

    4. Pneumonia

    5. Sepsis

    6. Trauma

    7. Aspiration

    8. Pancreatitis

    9. Presence of ARDS (per Berlin criteria) defined as follows:

    10. Acute onset (<48 hours)

    11. PaO2/FiO2<300 on PEEP≥5

    12. Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.

    13. Requirement for positive pressure ventilation via endotracheal tube

    14. 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

    8. Lung: Currently receiving home oxygen therapy as documented in medical record

    9. Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record

    10. Renal: Chronic renal failure requiring renal replacement therapy

    11. Liver: Severe chronic liver disease defined as Child-Pugh Class C

    12. Pre-existing, ongoing immunosuppression

    13. Solid organ transplant recipient

    14. Chronic high-dose corticosteroids (equivalent to >20 mg/prednisone/day for >14 days in the last 30 days)

    15. Oncolytic drug therapy within the past 14 days

    16. Known HIV positive with CD4 count <200 cells/mm3

    17. Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)

    18. Pregnancy

    19. History of hypersensitivity or idiosyncratic reaction to IC14

    20. Deprivation of freedom by administrative or court order

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Implicit Bioscience

    Investigators

    • Study Director: Jan Agosti, MD, Implicit Bioscience

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Implicit Bioscience
    ClinicalTrials.gov Identifier:
    NCT03017547
    Other Study ID Numbers:
    • AACTT01
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Mar 14, 2019
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury
    Syndrome

    Study Results

    No Results Posted as of Mar 14, 2019