<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/NCT02262130</url>
  </required_header>
  <id_info>
    <org_study_id>P/2013/209</org_study_id>
    <nct_id>NCT02262130</nct_id>
  </id_info>
  <brief_title>Omalizumab in Severe and Refractory Solar Urticaria</brief_title>
  <acronym>XOLUS</acronym>
  <official_title>Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and&#xD;
      with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual&#xD;
      treatment, leading to a large impact on quality of life. New treatment options are warranted.&#xD;
      The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody&#xD;
      recently approved in chronic spontaneous urticaria, in this setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-labelled multicentric phase II study testing the efficacy and the safety of&#xD;
      omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar&#xD;
      urticaria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">September 29, 2015</completion_date>
  <primary_completion_date type="Actual">September 29, 2015</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>Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)</measure>
    <time_frame>4 weeks after the end of treatment</time_frame>
    <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index&lt; 6</measure>
    <time_frame>4 and 12 weeks after the end of treatment</time_frame>
    <description>Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI &lt; 6.&#xD;
The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)</measure>
    <time_frame>12 weeks after the end of treatment</time_frame>
    <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity</measure>
    <time_frame>4 and 12 weeks after the end of treatment</time_frame>
    <description>Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving Clinical Remission of Solar Urticaria</measure>
    <time_frame>4 and 12 weeks after the end of treatment</time_frame>
    <description>Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Solar Urticaria</condition>
  <arm_group>
    <arm_group_label>Omalizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omalizumab 300 mg W0, W4 and W8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omalizumab</intervention_name>
    <arm_group_label>Omalizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; or equal to 18 years,&#xD;
&#xD;
          -  Appearance of wheals within 15 min after sun exposure and lasting &lt; 2 hr in the shade,&#xD;
&#xD;
          -  Wheals reproducible with phototesting: appearance after exposure to UVB, UVA or&#xD;
             visible light less than 30 min after exposure and lasting &lt; 2 hr,&#xD;
&#xD;
          -  Severity criteria:&#xD;
&#xD;
               -  Very large effect on quality of life, with Dermatology Life Quality Index (DLQI)&#xD;
                  &gt; 10, and&#xD;
&#xD;
               -  At least 1 of the following: involvement of the face, per annual eruption,&#xD;
                  extension of wheals on the non-photoexposed skin, SU triggered by artificial&#xD;
                  light, SU flares accompanied by bronchospasm or syncope.&#xD;
&#xD;
          -  Refractory criteria:&#xD;
&#xD;
               -  Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and&#xD;
&#xD;
               -  Resistance to administration of an association of 2 different antihistamines&#xD;
                  during 3 months or to photodesensitization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra indication to omalizumab&#xD;
&#xD;
          -  Previous treatment with omalizumab&#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_official>
    <last_name>Manuelle Viguier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique-Hôpitaux de Paris, Université Paris 7</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François AUBIN, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier régional universitaire de Besançon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology department, Centre Hospitalier Régional Universitaire</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology department, Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>March 24, 2017</results_first_submitted>
  <results_first_submitted_qc>October 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2018</results_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Omalizumab</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Urticaria, Solar</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 300 mg W0, W4 and W8&#xD;
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="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omalizumab</title>
          <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.9" spread="10.52"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)</title>
        <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
        <time_frame>4 weeks after the end of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)</title>
          <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index&lt; 6</title>
        <description>Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI &lt; 6.&#xD;
The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life</description>
        <time_frame>4 and 12 weeks after the end of treatment</time_frame>
        <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index&lt; 6</title>
          <description>Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI &lt; 6.&#xD;
The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life</description>
          <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)</title>
        <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
        <time_frame>12 weeks after the end of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)</title>
          <description>Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).&#xD;
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity</title>
        <description>Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)</description>
        <time_frame>4 and 12 weeks after the end of treatment</time_frame>
        <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity</title>
          <description>Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)</description>
          <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving Clinical Remission of Solar Urticaria</title>
        <description>Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions</description>
        <time_frame>4 and 12 weeks after the end of treatment</time_frame>
        <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</population>
        <group_list>
          <group group_id="O1">
            <title>Omalizumab</title>
            <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving Clinical Remission of Solar Urticaria</title>
          <description>Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions</description>
          <population>1 patient withdrawn between week 12 and week 20 (discontinuation)</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks after the end of treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Omalizumab</title>
          <description>Omalizumab 300 mg W0, W4 and W8&#xD;
Omalizumab</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystectomy</sub_title>
                <description>Gallbladder removal</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <description>Patient treated from 12th November 2014 to 17th June 2015. A positive pregnancy test was performed in September 2015 with echographic confirmation.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Faintness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Zona</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="37" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Solar urticaria relapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>
    <point_of_contact>
      <name_or_title>Pr Manuelle Viguier</name_or_title>
      <organization>CHU de Reims</organization>
      <phone>00333 26 78 43 43</phone>
      <email>mviguier@chu-reims.fr</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/NCT02262130
org study id: P/2013/209
nct id: NCT02262130
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and
      with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual
      treatment, leading to a large impact on quality of life. New treatment options are warranted.
      The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody
      recently approved in chronic spontaneous urticaria, in this setting.
This is an open-labelled multicentric phase II study testing the efficacy and the safety of
      omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar
      urticaria.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
time frame: 4 weeks after the end of treatment
description: Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
measure: Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
time frame: 4 and 12 weeks after the end of treatment
description: Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI < 6.
The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life
measure: Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
time frame: 12 weeks after the end of treatment
description: Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).
A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
measure: Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
time frame: 4 and 12 weeks after the end of treatment
description: Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
measure: Proportion of Patients Achieving Clinical Remission of Solar Urticaria
time frame: 4 and 12 weeks after the end of treatment
description: Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions
arm group label: Omalizumab
arm group type: Experimental
description: Omalizumab 300 mg W0, W4 and W8
intervention type: Drug
intervention name: Omalizumab
arm group label: Omalizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manuelle Viguier, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique-Hôpitaux de Paris, Université Paris 7
last name: François AUBIN, Prof.
role: Principal Investigator
affiliation: Centre hospitalier régional universitaire de Besançon
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Urticaria, Solar
mesh term: Omalizumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 