<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/NCT02191072</url>
  </required_header>
  <id_info>
    <org_study_id>201404056MIPC</org_study_id>
    <nct_id>NCT02191072</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria</brief_title>
  <official_title>Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and&#xD;
      phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab&#xD;
      as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous&#xD;
      urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset&#xD;
      of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab&#xD;
      will be effective in the treatment of severe acute urticaria as add on therapy with a fast&#xD;
      onset of action. Objective:To investigate the efficacy and safety of omalizumab in the&#xD;
      treatment of severe acute urticaria Study design: This prospective, interventional,&#xD;
      single-arm open label study will recruit patients with severe acute urticaria from emergency&#xD;
      departments, hospitalized and outpatient departments. The included patients will receive a&#xD;
      single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be&#xD;
      evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline,&#xD;
      1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity&#xD;
      of treatment-emergent adverse events will also be evaluated&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute urticaria is defined as hives that persist less than 6 weeks. Some patients with acute&#xD;
      urticaria may progressed and need urgent management at urgent care clinics and emergency&#xD;
      rooms. Nonsedating H1-antihistamines represent the mainstay and corticosteroids and various&#xD;
      immunosuppressive therapies are being used in severely affected patients, or for those&#xD;
      patients who experience a poor response to antihistamines. However, even though already&#xD;
      treated by antihistamines, the symptoms still last longer than 3 days in more than 34% of the&#xD;
      patients. Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in&#xD;
      phase II and phase III studies. Clinical symptoms and signs had been significantly reduced&#xD;
      with omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic&#xD;
      spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab&#xD;
      had an onset of effect within a week after initiation. Thus, the investigators hypothesize&#xD;
      that omalizumab will be effective in the treatment of severe acute urticaria as add on&#xD;
      therapy with a fast onset of action. Objective:To investigate the efficacy and safety of&#xD;
      omalizumab in the treatment of severe acute urticaria Study design: This prospective,&#xD;
      interventional, single-arm open label study will recruit patients with severe acute urticaria&#xD;
      from emergency departments, hospitalized and outpatient departments. The included patients&#xD;
      will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy of&#xD;
      omalizumab will be evaluated by physical examination and assessed by Urticaria Activity Score&#xD;
      (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The&#xD;
      frequency and severity of treatment-emergent adverse events will also be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <phase>N/A</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>Change in daily Urticaria Activity Score</measure>
    <time_frame>D0,1,2,3,4,5,6,7and 1 hour</time_frame>
    <description>Change in daily UAS from baseline to Day7 in the treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient with daily UAS=0 at Day 1, Day 3</measure>
    <time_frame>Day 1,3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in itch severity score</measure>
    <time_frame>Day 0,1,3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in size of largest hive score</measure>
    <time_frame>Day 0,1, 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient could stop H1-antihistamine treatment</measure>
    <time_frame>Day 0,3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of angioedema-free days</measure>
    <time_frame>Day 3,4,5,6,7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency and severity of treatment-emergent AEs and SAEs</measure>
    <time_frame>6 weeks follow-up period</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Urticaria</condition>
  <arm_group>
    <arm_group_label>omalizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>omalizumab 300mg subcutaneously once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>omalizumab</intervention_name>
    <description>a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)</description>
    <arm_group_label>omalizumab</arm_group_label>
    <other_name>xolair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-75 years(2)Documented diagnosis of acute urticaria within 3 years&#xD;
&#xD;
          -  Documented diagnosis of acute urticaria within 3 years&#xD;
&#xD;
          -  Daily UAS at the beginning of study more than or equal to 4&#xD;
&#xD;
          -  At time of enrollment, the symptoms of this episode had persisted longer than 3 days&#xD;
             even under oral/intravenous antihistamines with or without oral corticosteroid therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight &lt; 20 kg&#xD;
&#xD;
          -  Continuous use of suspected drugs that may induce acute urticaria&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Evidence of parasitic infection defined as having the following three items:Risk&#xD;
             factors for parasitic disease (living in an endemic area, chronic gastrointestinal&#xD;
             (GI) symptoms, travel within the last 6 months to an endemic area and/or chronic&#xD;
             immunosuppression) AND An absolute eosinophil count more than twice the upper limit of&#xD;
             normal AND Evidence of parasitic colonization or infection on stool evaluation for ova&#xD;
             and parasites. Note that stool ova and parasite evaluation will only be conducted in&#xD;
             patients with both risk factors and an eosinophil count more than twice the upper&#xD;
             limit of normal.&#xD;
&#xD;
          -  Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or&#xD;
             other skin disease associated with itch&#xD;
&#xD;
          -  Treatment with omalizumab within 12 months before screening&#xD;
&#xD;
          -  Treatment with any investigational agent within 30 days of screening&#xD;
&#xD;
          -  IV immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Day -14&#xD;
&#xD;
          -  Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to Day -14&#xD;
&#xD;
          -  Patients with current malignancy, history of malignancy, or currently under work-up&#xD;
             for suspected malignancy except non-melanoma skin cancer that has been treated or&#xD;
             excised and is considered resolved&#xD;
&#xD;
          -  Hypersensitivity to omalizumab or any component of the formulation&#xD;
&#xD;
          -  History of anaphylactic shock&#xD;
&#xD;
          -  Presence of clinically significant cardiovascular, neurological, psychiatric,&#xD;
             metabolic or other pathological conditions that could interfere with the&#xD;
             interpretation of the study results and or compromise the safety of the patients&#xD;
&#xD;
          -  Medical examination or laboratory findings that suggest the possibility of&#xD;
             decompensation of co-existing conditions for the duration of the study. Any items that&#xD;
             are cause for uncertainty must be reviewed with the Medical Monitor&#xD;
&#xD;
          -  Inability to comply with study and follow-up procedures&#xD;
&#xD;
          -  Evidence of current drug or alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsai Tsen-Fang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsien-Yi Chiu, MD</last_name>
    <phone>886-972654317</phone>
    <email>extra.owl0430@yahoo.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tsen-Fang Tasi, MD</last_name>
    <phone>886-2-23562141</phone>
    <email>tftsai@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Tsai Tsen-Fang</last_name>
      <phone>886-972651561</phone>
      <email>tftsai@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urticaria,omalizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02191072
org study id: 201404056MIPC
nct id: NCT02191072
lead sponsor: 
has dmc: No
Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and
      phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab
      as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous
      urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset
      of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab
      will be effective in the treatment of severe acute urticaria as add on therapy with a fast
      onset of action. Objective:To investigate the efficacy and safety of omalizumab in the
      treatment of severe acute urticaria Study design: This prospective, interventional,
      single-arm open label study will recruit patients with severe acute urticaria from emergency
      departments, hospitalized and outpatient departments. The included patients will receive a
      single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be
      evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline,
      1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity
      of treatment-emergent adverse events will also be evaluated
Acute urticaria is defined as hives that persist less than 6 weeks. Some patients with acute
      urticaria may progressed and need urgent management at urgent care clinics and emergency
      rooms. Nonsedating H1-antihistamines represent the mainstay and corticosteroids and various
      immunosuppressive therapies are being used in severely affected patients, or for those
      patients who experience a poor response to antihistamines. However, even though already
      treated by antihistamines, the symptoms still last longer than 3 days in more than 34% of the
      patients. Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in
      phase II and phase III studies. Clinical symptoms and signs had been significantly reduced
      with omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic
      spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab
      had an onset of effect within a week after initiation. Thus, the investigators hypothesize
      that omalizumab will be effective in the treatment of severe acute urticaria as add on
      therapy with a fast onset of action. Objective:To investigate the efficacy and safety of
      omalizumab in the treatment of severe acute urticaria Study design: This prospective,
      interventional, single-arm open label study will recruit patients with severe acute urticaria
      from emergency departments, hospitalized and outpatient departments. The included patients
      will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy of
      omalizumab will be evaluated by physical examination and assessed by Urticaria Activity Score
      (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The
      frequency and severity of treatment-emergent adverse events will also be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in daily Urticaria Activity Score
time frame: D0,1,2,3,4,5,6,7and 1 hour
description: Change in daily UAS from baseline to Day7 in the treatment period
measure: Proportion of patient with daily UAS=0 at Day 1, Day 3
time frame: Day 1,3
measure: Change from baseline in itch severity score
time frame: Day 0,1,3
measure: Change from baseline in size of largest hive score
time frame: Day 0,1, 3
measure: Proportion of patient could stop H1-antihistamine treatment
time frame: Day 0,3
measure: Proportion of angioedema-free days
time frame: Day 3,4,5,6,7
measure: The frequency and severity of treatment-emergent AEs and SAEs
time frame: 6 weeks follow-up period
arm group label: omalizumab
arm group type: Experimental
description: omalizumab 300mg subcutaneously once
intervention type: Drug
intervention name: omalizumab
description: a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)
arm group label: omalizumab
other name: xolair
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tsai Tsen-Fang
role: Principal Investigator
affiliation: Department of Dermatology, National Taiwan University Hospital
last name: Hsien-Yi Chiu, MD
phone: 886-972654317
email: extra.owl0430@yahoo.com.tw
last name: Tsen-Fang Tasi, MD
phone: 886-2-23562141
email: tftsai@yahoo.com
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Omalizumab