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A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IC14
Placebo
Sponsored by
Implicit Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    IC14

    Placebo

    Arm Description

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

    Placebo IV once daily on Study Day 1-4

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 9, 2017
    Last Updated
    March 12, 2019
    Sponsor
    Implicit Bioscience
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03017547
    Brief Title
    A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome
    Official Title
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Preliminary Efficacy Study of IC14 in Acute Respiratory Distress Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    seeking funding
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Implicit Bioscience

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IC14
    Arm Type
    Experimental
    Arm Description
    IC14 4 mg/kg IV on Study Day 1, then IC14 2 mg/kg IV once daily on Study Days 2-4.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo IV once daily on Study Day 1-4
    Intervention Type
    Drug
    Intervention Name(s)
    IC14
    Other Intervention Name(s)
    monoclonal antibody against CD14
    Intervention Description
    Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    sterile normal saline for infusion
    Primary Outcome Measure Information:
    Title
    Safety
    Description
    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.
    Time Frame
    28 days
    Title
    Ventilator-free days
    Description
    The number of days alive and free of mechanical ventilation through Day 28.
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Change in ARDS biologic markers.
    Description
    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
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Known HIV positive with CD4 count <200 cells/mm3 Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept) Pregnancy History of hypersensitivity or idiosyncratic reaction to IC14 Deprivation of freedom by administrative or court order
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Agosti, MD
    Organizational Affiliation
    Implicit Bioscience
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

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