<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/NCT04439955</url>
  </required_header>
  <id_info>
    <org_study_id>ST-SCU-01</org_study_id>
    <nct_id>NCT04439955</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients</brief_title>
  <official_title>A Phase 2a Placebo-controlled, Open-label, Single Center Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stero Biotechs Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stero Biotechs 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>
      Each patient will commence the study with a one month run-in period in which he/she will be&#xD;
      administered individual patient Standard of Care :anti-histamines and steroids as needed plus&#xD;
      placebo (olive oil).&#xD;
&#xD;
      After the run-in period, doses of CBD will be incresed during the first six weeks of the&#xD;
      study.&#xD;
&#xD;
      At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg&#xD;
      CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines,&#xD;
      patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional&#xD;
      follow-up period of three month.&#xD;
&#xD;
      Each patient will serve as his/her own control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each patient will commence the study with a one month run-in period in which he/she will be&#xD;
      administered individual patient Standard of Care :anti-histamines and steroids as needed plus&#xD;
      placebo (olive oil).&#xD;
&#xD;
      At the end of the one month run-in period, all trial subjects will continue on individual&#xD;
      Standard of Care plus increasing doses of CBD during the first six weeks of the study. Dosage&#xD;
      of CBD will start at 25 mg twice daily and will be increased once every 14 days, if no side&#xD;
      effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a&#xD;
      day CBD respectively. Treatment will be given with food.&#xD;
&#xD;
      At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg&#xD;
      CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines,&#xD;
      patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional&#xD;
      follow-up period of three months. In the case of flare, the patient will be treated with&#xD;
      higher dose of Anti-histamines and Steroides if needed in addition to CBD. Once the flare has&#xD;
      been brought under control, then another attempt will be made to discontinue the steroids and&#xD;
      continue treating with CBD + Anti-histamines only. Each patient will serve as his/her own&#xD;
      control.&#xD;
&#xD;
      Laboratory studies will be carried out at the beginning of the study (baseline), and then on&#xD;
      a monthly basis until the end of the study.&#xD;
&#xD;
      Adverse events will be continuously assessed throughout the study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>
    <intervention_model_description>each patient will commence the study with a one month run-in period in which he/she will be administered individual with placebo (olive oil). At the end of the one month run-in period, all trial subjects will receive CBD</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Event reporting of up to 300 mg CBD/day</measure>
    <time_frame>6 month</time_frame>
    <description>measured by Adverse Events significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in total steroid dose reporting</measure>
    <time_frame>6 month</time_frame>
    <description>Total steroid dose needed to control flares during CBD administration period per patient versus the total steroid dose administered during the one month placebo run-in period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of days of flares</measure>
    <time_frame>6 month</time_frame>
    <description>Total number of days of flares/month experienced per patient during CBD administration versus the total number of days of flares experienced during the one month placebo run-in period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in anti histamine use reporting</measure>
    <time_frame>6 month</time_frame>
    <description>Percentage of patients who demonstrated a 50% reduction in anti-histamine use during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life questionnaires</measure>
    <time_frame>6 month</time_frame>
    <description>via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Spontaneous Urticaria</condition>
  <arm_group>
    <arm_group_label>CBD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the end of the one month run-in period, all trial subjects will continue on individual Standard of case plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice a day and will be increased once every 14 days, if no side effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day CBD respectively. Treatment will be given with food. If the 300 mg CBD dose level is deemed safe for two weeks patients will continue receiving 300 mg CBD +for an additional follow-up period of three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CBD</intervention_name>
    <description>300 mg CBD</description>
    <arm_group_label>CBD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with active CSU for at least 4 months which was treated with anti-histamines&#xD;
             as well as at least one course of steroids (ex. Prednisone)&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Patients will undergo an ECG and QT parameters will be measured for further analysis.&#xD;
&#xD;
          -  Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a&#xD;
             follicle stimulating hormone test), or who are surgically sterilized may be enrolled.&#xD;
             Similarly, women of childbearing potential who had a negative pregnancy test at&#xD;
             screening, who are willing to use two medically acceptable methods of contraception&#xD;
             for the duration of the study as well as for at least three months after cessation of&#xD;
             CBD treatment and who are willing to undergo pregnancy testing according to the study&#xD;
             protocol may be enrolled.&#xD;
&#xD;
          -  Female subjects who are not breast-feeding and who have no intention to breast-feed&#xD;
             during the term of the trial and for at least three months after cessation of CBD&#xD;
             treatment may be enrolled.&#xD;
&#xD;
          -  Subject able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Viral Hepatitis (HAV, HBV, HCV)&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  Serious psychiatric or psychological disorders&#xD;
&#xD;
          -  Other chronic dermatological conditions under active treatment&#xD;
&#xD;
          -  Active consumption of illicit drugs including cannabis or derivatives for at least&#xD;
             three months prior to the study&#xD;
&#xD;
          -  Patients with significant cardiac, respiratory or active malignance disease (except&#xD;
             Basel Cell Carcinoma) comorbidities.&#xD;
&#xD;
          -  Any uncontrolled infection at time of registration&#xD;
&#xD;
          -  Renal comorbidity: eGFR &lt; 30 mL/min/1.73m2 (note: CKD Grade 4 is defined as eGFR 15-29&#xD;
             mL/min/1.73 m2)&#xD;
&#xD;
          -  Patient who is taking immunomodulatory medications for other indication&#xD;
&#xD;
          -  Women of child-bearing potential who intend to become pregnant or who are pregnant or&#xD;
             breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ronit Konfino, Prof.</last_name>
    <phone>97297472718</phone>
    <email>ronitco@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronit Konfini, Prof.</last_name>
      <email>ronitco@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 16, 2019</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</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>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</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/NCT04439955
org study id: ST-SCU-01
nct id: NCT04439955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Each patient will commence the study with a one month run-in period in which he/she will be
      administered individual patient Standard of Care :anti-histamines and steroids as needed plus
      placebo (olive oil).

      After the run-in period, doses of CBD will be incresed during the first six weeks of the
      study.

      At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg
      CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines,
      patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional
      follow-up period of three month.

      Each patient will serve as his/her own control.
Each patient will commence the study with a one month run-in period in which he/she will be
      administered individual patient Standard of Care :anti-histamines and steroids as needed plus
      placebo (olive oil).

      At the end of the one month run-in period, all trial subjects will continue on individual
      Standard of Care plus increasing doses of CBD during the first six weeks of the study. Dosage
      of CBD will start at 25 mg twice daily and will be increased once every 14 days, if no side
      effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a
      day CBD respectively. Treatment will be given with food.

      At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg
      CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines,
      patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional
      follow-up period of three months. In the case of flare, the patient will be treated with
      higher dose of Anti-histamines and Steroides if needed in addition to CBD. Once the flare has
      been brought under control, then another attempt will be made to discontinue the steroids and
      continue treating with CBD + Anti-histamines only. Each patient will serve as his/her own
      control.

      Laboratory studies will be carried out at the beginning of the study (baseline), and then on
      a monthly basis until the end of the study.

      Adverse events will be continuously assessed throughout the study
allocation: N/A
intervention model: Single Group Assignment
intervention model description: each patient will commence the study with a one month run-in period in which he/she will be administered individual with placebo (olive oil). At the end of the one month run-in period, all trial subjects will receive CBD
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Event reporting of up to 300 mg CBD/day
time frame: 6 month
description: measured by Adverse Events significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups
measure: change in total steroid dose reporting
time frame: 6 month
description: Total steroid dose needed to control flares during CBD administration period per patient versus the total steroid dose administered during the one month placebo run-in period
measure: Number of days of flares
time frame: 6 month
description: Total number of days of flares/month experienced per patient during CBD administration versus the total number of days of flares experienced during the one month placebo run-in period
measure: change in anti histamine use reporting
time frame: 6 month
description: Percentage of patients who demonstrated a 50% reduction in anti-histamine use during the study
measure: change in quality of life questionnaires
time frame: 6 month
description: via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit
arm group label: CBD
arm group type: Experimental
description: At the end of the one month run-in period, all trial subjects will continue on individual Standard of case plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice a day and will be increased once every 14 days, if no side effects are observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day CBD respectively. Treatment will be given with food. If the 300 mg CBD dose level is deemed safe for two weeks patients will continue receiving 300 mg CBD +for an additional follow-up period of three months
intervention type: Drug
intervention name: CBD
description: 300 mg CBD
arm group label: CBD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronit Konfino, Prof.
phone: 97297472718
email: ronitco@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Chronic Urticaria
sharing ipd: No