<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03808103</url>
  </required_header>
  <id_info>
    <org_study_id>ITX/EA-002</org_study_id>
    <nct_id>NCT03808103</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease</brief_title>
  <official_title>A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intralytix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MOUNT SINAI HOSPITAL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intralytix, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety of oral administration of EcoActive to patients with&#xD;
      inactive Crohn's disease and how it affects the levels of AIEC in stool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if EcoActive is safe and effective in people with&#xD;
      Crohn's disease. EcoActive is a collection of bacteriophages. Bacteriophages (or phages) are&#xD;
      viruses that infect only bacteria. The phages in EcoActive infect a specific type of bacteria&#xD;
      called Adherent Invasive Escherichia coli (AIEC).&#xD;
&#xD;
      The cause of Crohn's disease is poorly understood. However, the presence of AIEC in the&#xD;
      intestines is associated with worsening inflammation in this disease. Inflammation is the&#xD;
      presence of redness, irritation, and ulcers in the intestines. By using phages that only&#xD;
      infect and kill this specific type of bacteria (AIEC), it is the hope this can be used to&#xD;
      improve the course of Crohn's disease. The phages would only target the AIEC, without&#xD;
      affecting the natural, often helpful, bacteria of the intestines. EcoActive may also lessen&#xD;
      the use of antibiotics to control symptoms. When antibiotics are used, they can have major&#xD;
      effects on the rest of the bacteria in the intestines. Also, repeated use can cause&#xD;
      intestinal bacteria to become resistant to antibiotics. Reduced use of antibiotics would&#xD;
      limit both of these risks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The number of solicited and unsolicited adverse events will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of adverse events</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The severity will be graded according to the definitions and values stated in CTCAE V04 v4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on Harvey Bradshaw Index (HBI)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The effect on Crohn's disease activity will be evaluated using the HBI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammation, as indicated by C-reactive protein (CRP)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The changes in CRP from baseline will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on inflammation, as indicated by fecal calprotectin</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The changes in fecal calprotectin levels from baseline will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on the incidence and levels of AIEC</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The secondary objective is to assess the effect of oral phage administration on the AIEC (CFU/g) in stools of patients receiving phages vs. patients receiving placebo.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dose is 1mL of placebo given orally twice a day for 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orally, twice a day, for a period of fifteen days</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>0.9% saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bacteriophage preparation</intervention_name>
    <description>Orally, twice a day, for a period of fifteen days</description>
    <arm_group_label>Phage</arm_group_label>
    <other_name>EcoActive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years of age&#xD;
&#xD;
          2. Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw&#xD;
             Index (HBI) &lt; 4&#xD;
&#xD;
          3. Permitted CD medications expected to remain stable during the period of the study (see&#xD;
             Section 7 &quot;Concomitant Crohn's Disease Medications&quot; for allowed and prohibited drugs).&#xD;
&#xD;
          4. Crohn's disease history ≥ 6-month duration&#xD;
&#xD;
          5. CRP (C-reactive protein) within normal range at the Screening visit (based on normal&#xD;
             range of the local laboratory)&#xD;
&#xD;
          6. Fecal calprotectin level ≤ 150 µg/g at the Screening visit&#xD;
&#xD;
          7. AIEC detected in the stool&#xD;
&#xD;
          8. Females of childbearing age must be using an effective method of contraception to&#xD;
             prevent pregnancy and agree to continue to practice an acceptable method of&#xD;
             contraception for the duration of participation in the study (contraceptive measures&#xD;
             considered adequate are: intrauterine devices, hormonal contraceptives, such as&#xD;
             contraceptive pills, implants, transdermal patches, hormonal vaginal devices or&#xD;
             injections with prolonged release).&#xD;
&#xD;
          9. Negative pregnancy test for women of childbearing age (menarche to menopause)&#xD;
&#xD;
         10. Patient understands the study procedures, and can sign the informed consent, and the&#xD;
             authorization to release relevant protected health information to the Study&#xD;
             Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4&#xD;
&#xD;
          2. Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding&#xD;
&#xD;
          3. Active malignancies or any malignant disease within the past 5 years&#xD;
&#xD;
          4. Indeterminate colitis, ulcerative colitis&#xD;
&#xD;
          5. Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).&#xD;
&#xD;
          6. Colonic or small bowel stoma&#xD;
&#xD;
          7. Active perianal lesions&#xD;
&#xD;
          8. Women who are pregnant or nursing, or plan to become pregnant during the study period&#xD;
&#xD;
          9. Severe uncontrolled diseases that could increase the risk for subjects participating&#xD;
             in the study, including but not limited to: heart diseases, congestive heart failure,&#xD;
             hypertension, lung diseases; endocrine diseases; clinically significant renal disease&#xD;
             characterized by a glomerular filtration rate &lt; 60mL/min, hepatic diseases,&#xD;
             haematological disorders, or other conditions that in the opinion of the Investigator&#xD;
             could interfere with the interpretation of the study results.&#xD;
&#xD;
         10. Taking supplemental probiotics in the form of pills or tablets.&#xD;
&#xD;
         11. History or planned procedures specifically aimed at modifying the gastrointestinal&#xD;
             microbiota within the past year.&#xD;
&#xD;
         12. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior to the&#xD;
             Screening visit or planned during the study period&#xD;
&#xD;
         13. Use of bowel cleansing or preparation for endoscopy, TDM or MRI in the 4 weeks prior&#xD;
             to the Screening visit or planned during the study period.&#xD;
&#xD;
         14. Receipt of antibiotics 4 weeks before the Screening visit or planned during the study&#xD;
             period.&#xD;
&#xD;
         15. Known allergy or hypersensitivity to an excipient in the study drug or placebo&#xD;
&#xD;
         16. Psychological or linguistic incapability to sign the informed consent.&#xD;
&#xD;
         17. Lack or expected lack of cooperation or compliance with the study.&#xD;
&#xD;
         18. Receipt of mesalamine based therapies within 4 weeks of the screening visit.&#xD;
&#xD;
         19. Severe psychiatric, psychological, or neurological disorders.&#xD;
&#xD;
         20. Alcohol, drug or medication abuse within the past year.&#xD;
&#xD;
         21. Subject who cannot be contacted in case of emergency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Frederic Colombel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander Sulakvelidze, PhD</last_name>
    <phone>410-625-2533</phone>
    <email>asulakvelidze@intralytix.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Schwartz, PhD</last_name>
    <phone>667-215-2597</phone>
    <email>jschwartz@intralytix.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Nolan</last_name>
      <phone>212-824-7699</phone>
    </contact>
    <investigator>
      <last_name>Robert Hirten, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phage</keyword>
  <keyword>Bacteriophage</keyword>
  <keyword>AIEC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03808103
org study id: ITX/EA-002
nct id: NCT03808103
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety of oral administration of EcoActive to patients with
      inactive Crohn's disease and how it affects the levels of AIEC in stool.
The purpose of this study is to determine if EcoActive is safe and effective in people with
      Crohn's disease. EcoActive is a collection of bacteriophages. Bacteriophages (or phages) are
      viruses that infect only bacteria. The phages in EcoActive infect a specific type of bacteria
      called Adherent Invasive Escherichia coli (AIEC).

      The cause of Crohn's disease is poorly understood. However, the presence of AIEC in the
      intestines is associated with worsening inflammation in this disease. Inflammation is the
      presence of redness, irritation, and ulcers in the intestines. By using phages that only
      infect and kill this specific type of bacteria (AIEC), it is the hope this can be used to
      improve the course of Crohn's disease. The phages would only target the AIEC, without
      affecting the natural, often helpful, bacteria of the intestines. EcoActive may also lessen
      the use of antibiotics to control symptoms. When antibiotics are used, they can have major
      effects on the rest of the bacteria in the intestines. Also, repeated use can cause
      intestinal bacteria to become resistant to antibiotics. Reduced use of antibiotics would
      limit both of these risks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Incidence of adverse events
time frame: Up to 6 months
description: The number of solicited and unsolicited adverse events will be recorded.
measure: Severity of adverse events
time frame: Up to 6 months
description: The severity will be graded according to the definitions and values stated in CTCAE V04 v4.
measure: Effect on Harvey Bradshaw Index (HBI)
time frame: Up to 6 months
description: The effect on Crohn's disease activity will be evaluated using the HBI.
measure: Effect on inflammation, as indicated by C-reactive protein (CRP)
time frame: Up to 6 months
description: The changes in CRP from baseline will be evaluated.
measure: Effect on inflammation, as indicated by fecal calprotectin
time frame: Up to 6 months
description: The changes in fecal calprotectin levels from baseline will be evaluated.
measure: Effect on the incidence and levels of AIEC
time frame: Up to 6 months
description: The secondary objective is to assess the effect of oral phage administration on the AIEC (CFU/g) in stools of patients receiving phages vs. patients receiving placebo.
arm group label: Placebo
arm group type: Placebo Comparator
description: Dose is 1mL of placebo given orally twice a day for 15 days
arm group label: Phage
arm group type: Experimental
description: Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days
intervention type: Biological
intervention name: Placebo
description: Orally, twice a day, for a period of fifteen days
arm group label: Placebo
other name: 0.9% saline
intervention type: Biological
intervention name: Bacteriophage preparation
description: Orally, twice a day, for a period of fifteen days
arm group label: Phage
other name: EcoActive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Frederic Colombel, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
last name: Alexander Sulakvelidze, PhD
phone: 410-625-2533
email: asulakvelidze@intralytix.com
last name: Jennifer Schwartz, PhD
phone: 667-215-2597
email: jschwartz@intralytix.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Crohn Disease
sharing ipd: No