<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/NCT01701583</url>
  </required_header>
  <id_info>
    <org_study_id>12-0780</org_study_id>
    <nct_id>NCT01701583</nct_id>
  </id_info>
  <brief_title>Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria</brief_title>
  <official_title>Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 looks at changes in cell proteins in people with chronic hives treated with&#xD;
      omalizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate for changes in the proteins produced in white blood&#xD;
      cells (basophils) in patients with chronic hives who are treated with and respond to&#xD;
      omalizumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 4</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 the Basophil Proteome</measure>
    <time_frame>Baseline through week 13</time_frame>
    <description>In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.</measure>
    <time_frame>Baseline through week 13</time_frame>
    <description>Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Urticaria</condition>
  <arm_group>
    <arm_group_label>Omalizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omalizumab</intervention_name>
    <description>Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.</description>
    <arm_group_label>Omalizumab</arm_group_label>
    <other_name>Xolair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic urticaria (hives) for more than 6 weeks.&#xD;
&#xD;
          -  No improvement with standard doses of antihistamines (loratadine 10 mg daily,&#xD;
             desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or&#xD;
             levocetirizine 5 mg daily)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taken any oral steroids for 1 month prior to beginning the study.&#xD;
&#xD;
          -  Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine,&#xD;
             cyclosporine, methotrexate) for 1 month prior to beginning the study.&#xD;
&#xD;
          -  Physical urticaria as a primary diagnosis.&#xD;
&#xD;
          -  Known allergic precipitant of urticaria such as foods.&#xD;
&#xD;
          -  Urticarial Vasculitis.&#xD;
&#xD;
          -  Anemia.&#xD;
&#xD;
          -  Asthma.&#xD;
&#xD;
          -  Serum Immunoglobulin E (IgE) &gt;700 IU/ml.&#xD;
&#xD;
          -  Women of childbearing potential not using contraception method(s), as well as women&#xD;
             who are pregnant and/or breastfeeding.&#xD;
&#xD;
          -  Known sensitivity to omalizumab or this class of drug.&#xD;
&#xD;
          -  Use of any other investigational agent in the last 1 month.&#xD;
&#xD;
          -  Untreated intercurrent illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Dreskin, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. Epub 2018 May 20. No abstract available.</citation>
    <PMID>29671921</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>May 30, 2018</results_first_submitted>
  <results_first_submitted_qc>November 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 4, 2020</results_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Idiopathic Urticaria</keyword>
  <keyword>CIU</keyword>
  <keyword>Urticaria</keyword>
  <keyword>Chronic Hives</keyword>
  <keyword>Xolair</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omalizumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Omalizumab</title>
          <description>Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Controls</title>
          <description>Control subjects without urticaria who did not receive omalizumab</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline demographic data for participants who did or did not received Omalizumab are combined in order to protect the privacy of the three control participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Omalizumab</title>
          <description>Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.</description>
        </group>
        <group group_id="B2">
          <title>Controls</title>
          <description>Control subjects without urticaria who did not receive omalizumab</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urticaria Activity Score for 7 days</title>
          <description>The Urticaria Activity Score summed over 7 days (UAS7) is a self-reported diary based measure used to assess itch severity and hive count in chronic spontaneous urticaria (CSU). Scores range from 0 to 42, with higher scores indicating more severe disease activity.</description>
          <population>Only the 7 subjects with urticaria completed UAS7 scores. The 3 controls did not have urticaria.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="11"/>
                    <measurement group_id="B3" value="30" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in the Basophil Proteome</title>
        <description>In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.</description>
        <time_frame>Baseline through week 13</time_frame>
        <population>There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. There was insufficient data for weeks 6 and 13 to analyze primary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab Responders</title>
            <description>Subjects with chronic urticaria, treated with omalizumab who responded to the drug</description>
          </group>
          <group group_id="O2">
            <title>Controls</title>
            <description>Subjects without chronic urticaria, not treated with omalizumab</description>
          </group>
          <group group_id="O3">
            <title>Omalizumab Non-responders</title>
            <description>Subjects with chronic urticaria, treated with omalizumab who did not respond to the drug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Basophil Proteome</title>
          <description>In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.</description>
          <population>There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. There was insufficient data for weeks 6 and 13 to analyze primary outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.</title>
        <description>Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.</description>
        <time_frame>Baseline through week 13</time_frame>
        <population>There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. Because the data from subsequent time points was not able to be analyzed, the investigators were unable to analyze this outcome because no change comparison could be made.</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab Responders</title>
            <description>Subjects with chronic urticaria, treated with omalizumab who responded to the drug</description>
          </group>
          <group group_id="O2">
            <title>Controls</title>
            <description>Subjects without chronic urticaria, not treated with omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.</title>
          <description>Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.</description>
          <population>There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. Because the data from subsequent time points was not able to be analyzed, the investigators were unable to analyze this outcome because no change comparison could be made.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to week 13</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Omalizumab</title>
          <description>Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Controls</title>
          <description>Control subjects without urticaria who did not receive omalizumab</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Unable to assess primary or secondary outcome due to insufficient data at weeks 6 and 13.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jenny Stitt</name_or_title>
      <organization>University of Colorado</organization>
      <phone>303-724-7205</phone>
      <email>jenny.stitt@ucdenver.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01701583
org study id: 12-0780
nct id: NCT01701583
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study looks at changes in cell proteins in people with chronic hives treated with
      omalizumab.
The purpose of this study is to evaluate for changes in the proteins produced in white blood
      cells (basophils) in patients with chronic hives who are treated with and respond to
      omalizumab.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Basophil Proteome
time frame: Baseline through week 13
description: In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.
measure: Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.
time frame: Baseline through week 13
description: Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.
arm group label: Omalizumab
arm group type: Experimental
description: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
intervention type: Drug
intervention name: Omalizumab
description: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
arm group label: Omalizumab
other name: Xolair
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stephen Dreskin, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. Epub 2018 May 20. No abstract available.
PMID: 29671921
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Chronic Urticaria
mesh term: Omalizumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Unable to assess primary or secondary outcome due to insufficient data at weeks 6 and 13.
point of contact: 