<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/NCT03755167</url>
  </required_header>
  <id_info>
    <org_study_id>101/3</org_study_id>
    <nct_id>NCT03755167</nct_id>
  </id_info>
  <brief_title>A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV</brief_title>
  <official_title>An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunity Pharma Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immunity Pharma Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by&#xD;
      IPL344 IV administered once a day in up to 15 participants with ALS.&#xD;
&#xD;
      The study is designed to determine the safety, tolerability and initial efficacy of IPL344,&#xD;
      administered once a day, by IV infusion for up to 36 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 9, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting</measure>
    <time_frame>upto 36 month</time_frame>
    <description>All AEs will be recorded, whether considered minor or serious, drug-related or not</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in ALS disease progression</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Evaluated by the Amyotrophic Lateral Sclerosis Functional Rating Scale(ALSFRS-R). The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes from baseline in Pulmonary Function</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Measured by Vital Capacity (VC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes from baseline in Muscle strength</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes from baseline in Muscle strength</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Assessed by using a quantitative strength testing tool - hand grip</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes from baseline in Anti-Depression effect</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Evaluated by ALS Depression Inventory (ADI-12). Scales: For each question, the following is selected: &quot;I fully agree&quot;, &quot;I agree&quot;, &quot;I don't agree&quot;, &quot;I do not agree at all&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes from baseline in Anti-Depression effect</measure>
    <time_frame>upto 36 months</time_frame>
    <description>Evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Amyotrophic Lateral Sclerosis (ALS)</condition>
  <arm_group>
    <arm_group_label>IPL344</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV IPL344 administered once a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPL344</intervention_name>
    <description>IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).</description>
    <arm_group_label>IPL344</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants ages ≥ 18 to 75 years.&#xD;
&#xD;
          2. Participants that have completed study protocol #101/2&#xD;
&#xD;
          3. A written informed consent signed prior to any study procedure being performed&#xD;
&#xD;
          4. Medically capable to undergo study procedures at the time of study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants that did not participate or did not complete 28 treatment days of study&#xD;
             protocol #101/2.&#xD;
&#xD;
          2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of&#xD;
             the safety or efficacy of the study medication&#xD;
&#xD;
          3. Presence of any other condition or circumstance that, in the judgment of the&#xD;
             Investigator, might contraindicate or increase the risk to the participant.&#xD;
&#xD;
          4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a&#xD;
             negative serum pregnancy test from protocol 101/2)&#xD;
&#xD;
          5. Women of child-bearing potential or males whose partners are women of child-bearing&#xD;
             potential, unwilling or unable to use an effective method of contraception throughout&#xD;
             the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marc Gotkine, M.D.</last_name>
    <phone>+972 2 6778899</phone>
    <email>marc@gotkine.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center -Motor Neuron Disease Clinic</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Gotkune, M.D.</last_name>
      <phone>+972 2 6778899</phone>
      <email>marc@gotkine.com</email>
    </contact>
    <investigator>
      <last_name>Marc Kotkine, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 6, 2019</last_update_submitted>
  <last_update_submitted_qc>September 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03755167
org study id: 101/3
nct id: NCT03755167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by
      IPL344 IV administered once a day in up to 15 participants with ALS.

      The study is designed to determine the safety, tolerability and initial efficacy of IPL344,
      administered once a day, by IV infusion for up to 36 months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
time frame: upto 36 month
description: All AEs will be recorded, whether considered minor or serious, drug-related or not
measure: Changes from baseline in ALS disease progression
time frame: upto 36 months
description: Evaluated by the Amyotrophic Lateral Sclerosis Functional Rating Scale(ALSFRS-R). The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing
measure: Changes from baseline in Pulmonary Function
time frame: upto 36 months
description: Measured by Vital Capacity (VC)
measure: Changes from baseline in Muscle strength
time frame: upto 36 months
description: Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)
measure: Changes from baseline in Muscle strength
time frame: upto 36 months
description: Assessed by using a quantitative strength testing tool - hand grip
measure: Changes from baseline in Anti-Depression effect
time frame: upto 36 months
description: Evaluated by ALS Depression Inventory (ADI-12). Scales: For each question, the following is selected: "I fully agree", "I agree", "I don't agree", "I do not agree at all"
measure: Changes from baseline in Anti-Depression effect
time frame: upto 36 months
description: Evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains
arm group label: IPL344
arm group type: Experimental
description: IV IPL344 administered once a day
intervention type: Drug
intervention name: IPL344
description: IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
arm group label: IPL344
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marc Gotkine, M.D.
phone: +972 2 6778899
email: marc@gotkine.com
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided