<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/NCT02213367</url>
  </required_header>
  <id_info>
    <org_study_id>BUCSU</org_study_id>
    <nct_id>NCT02213367</nct_id>
  </id_info>
  <brief_title>Bilastine Updosing in Chronic Spontaneous Urticaria</brief_title>
  <official_title>Phase 3 Study, Exploratory, Disease Activity Controlled Dose Escalating Study to Assess the Efficacy, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Chronic Spontaneous Urticaria.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and&#xD;
      chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the&#xD;
      population suffers from the disease. Although all age groups can be affected, the peak&#xD;
      incidence is seen between 20 and 40 years of age. The duration of the disease is generally&#xD;
      several years but is likely to be longer in more severe cases, cases with concurrent&#xD;
      angioedema, in combination with physical urticaria or with a positive autologous serum skin&#xD;
      test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep&#xD;
      deprivation and psychiatric comorbidity being frequent. It also has a large impact on society&#xD;
      in terms of direct and indirect health care costs as well as reduced performance at work and&#xD;
      in private life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on disease activity in patients with chronic spontaneous urticaria.</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on quality of life impairment in patients with chronic spontaneous urticaria.</measure>
    <time_frame>4 weeks</time_frame>
    <description>To assess the safety of bilastine in doses of 20 mg, 40 mg and 80 mg in chronic spontaneous urticaria patients by documentation of adverse events.&#xD;
To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on biomarkers of chronic spontaneous urticaria, such as substance P and D-Dimers</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Urticaria</condition>
  <arm_group>
    <arm_group_label>20 mg Bilastin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20mg Bilastine once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilastin 40mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg Bilastine once daily, intake of two tablets 20mg Bilastine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilastin 80mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>80 mg Bilastine once daily, intake of four tablets 20mg Bilastine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine</intervention_name>
    <description>20mg (8 weeks)</description>
    <arm_group_label>20 mg Bilastin</arm_group_label>
    <arm_group_label>Bilastin 40mg</arm_group_label>
    <arm_group_label>Bilastin 80mg</arm_group_label>
    <other_name>Bilaxten</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastine</intervention_name>
    <description>40mg</description>
    <arm_group_label>20 mg Bilastin</arm_group_label>
    <arm_group_label>Bilastin 40mg</arm_group_label>
    <arm_group_label>Bilastin 80mg</arm_group_label>
    <other_name>Bilaxten</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bilastin</intervention_name>
    <description>80mg</description>
    <arm_group_label>20 mg Bilastin</arm_group_label>
    <arm_group_label>Bilastin 40mg</arm_group_label>
    <arm_group_label>Bilastin 80mg</arm_group_label>
    <other_name>Bilaxten</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 18 years and older&#xD;
&#xD;
          -  History of active chronic spontaneous urticaria with or without associated angioedema&#xD;
             for at least three days per week over the last 6 weeks prior to visit 1. - Urticaria&#xD;
             symptoms must comprise wheals and itch&#xD;
&#xD;
          -  History of failed treatment with an antihistamine other than bilastine in standard&#xD;
             (licensed) dose.&#xD;
&#xD;
          -  UAS7 of ≥14 during baseline&#xD;
&#xD;
          -  Informed consent signed and dated&#xD;
&#xD;
          -  Able to read, understand and willing to sign the informed consent form and abide with&#xD;
             study procedures&#xD;
&#xD;
          -  Willing, committed and able to return for all clinic visits and complete all&#xD;
             study-related procedures&#xD;
&#xD;
          -  In females of childbearing potential: negative pregnancy test; females willing to use&#xD;
             highly effective contraception (Pearl-Index &lt; 1) a woman will be considered not of&#xD;
             childbearing potential if she is post-menopausal for &gt; 2 years or surgically sterile&#xD;
             (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)&#xD;
&#xD;
          -  No participation in other clinical trials 4 weeks before and after participation in&#xD;
             this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic spontaneous urticaria patients with a known resistance to bilastine&#xD;
&#xD;
          -  Isolated presence or domination of inducible forms of urticaria or cholinergic&#xD;
             urticaria (no chronic spontaneous urticaria)&#xD;
&#xD;
          -  History of adverse reactions to bilastine or known hypersensitivity to bilastine or&#xD;
             its ingredients&#xD;
&#xD;
          -  Intake of oral corticosteroids or intravenously applied corticosteroids within 28 days&#xD;
             prior to screening visit&#xD;
&#xD;
          -  Use of depot corticosteroids within 3 months prior to screening visit (inhaled&#xD;
             corticosteroids are allowed)&#xD;
&#xD;
          -  Use of systemic immunosupressants/immunomodulators such as ciclosporin, dapsone,&#xD;
             metotrexate, and comparable drugs within 28 days prior to screening visit.&#xD;
&#xD;
          -  Use of UV-therapy within 28 days prior to visit 1&#xD;
&#xD;
          -  Significant medical condition, in the opinion of the Investigator, rendering the&#xD;
             patient immunocompromised or not suitable for a clinical trial&#xD;
&#xD;
          -  Significant concomitant illness, in the opinion of the Investigator, that would&#xD;
             adversely affect the subject's participation or evaluation in this study&#xD;
&#xD;
          -  ECG alterations of repolarisation (QTc prolongations &gt;450ms or increase of QTc &gt;60ms&#xD;
             as compared to the baseline assessment)&#xD;
&#xD;
          -  Blood pressure &gt;180/100 mmHg and/or heart rate &gt;100/min&#xD;
&#xD;
          -  Evidence of significant hepatic or renal disease (GOT and/or GPT &gt;2 times above the&#xD;
             upper reference value, serum creatinine 1.5 times above the upper reference value)&#xD;
&#xD;
          -  Subjects for whom there is concern, in the opinion of the Investigator, about&#xD;
             compliance with the protocol procedures&#xD;
&#xD;
          -  The presence of a permanent gastrointestinal condition which may influence the oral&#xD;
             therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations&#xD;
             of gastrointestinal tract)&#xD;
&#xD;
          -  Presence of active cancer which requires chemotherapy or radiation therapy&#xD;
&#xD;
          -  Presence of alcohol abuse or drug addiction&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  Subjects who are inmates of psychiatric wards, prisons, or other state institutions.&#xD;
             Existing or planned placement in an institution after ruling according to § 40 passage&#xD;
             1, number 4 AMG (Arzneimittelgesetz).&#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>Karsten Weller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dpt. of Dermatology and Allergy , Charité</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dpt. of Dermatology and Allergy</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 25, 2016</last_update_submitted>
  <last_update_submitted_qc>August 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>K. Weller</investigator_full_name>
    <investigator_title>PD</investigator_title>
  </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>
  <!-- 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/NCT02213367
org study id: BUCSU
nct id: NCT02213367
lead sponsor: 
has dmc: No
Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and
      chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the
      population suffers from the disease. Although all age groups can be affected, the peak
      incidence is seen between 20 and 40 years of age. The duration of the disease is generally
      several years but is likely to be longer in more severe cases, cases with concurrent
      angioedema, in combination with physical urticaria or with a positive autologous serum skin
      test (autoreactivity). CSU has major detrimental effects on quality of life, with sleep
      deprivation and psychiatric comorbidity being frequent. It also has a large impact on society
      in terms of direct and indirect health care costs as well as reduced performance at work and
      in private life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on disease activity in patients with chronic spontaneous urticaria.
time frame: 8 weeks
measure: To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on quality of life impairment in patients with chronic spontaneous urticaria.
time frame: 4 weeks
description: To assess the safety of bilastine in doses of 20 mg, 40 mg and 80 mg in chronic spontaneous urticaria patients by documentation of adverse events.
To assess the effects of standard dose (20 mg) and higher than standard dose of bilastine (40 mg and 80 mg) on biomarkers of chronic spontaneous urticaria, such as substance P and D-Dimers
arm group label: 20 mg Bilastin
arm group type: Active Comparator
description: 20mg Bilastine once daily
arm group label: Bilastin 40mg
arm group type: Active Comparator
description: 40 mg Bilastine once daily, intake of two tablets 20mg Bilastine
arm group label: Bilastin 80mg
arm group type: Active Comparator
description: 80 mg Bilastine once daily, intake of four tablets 20mg Bilastine
intervention type: Drug
intervention name: Bilastine
description: 20mg (8 weeks)
arm group label: 20 mg Bilastin
arm group label: Bilastin 40mg
arm group label: Bilastin 80mg
other name: Bilaxten
intervention type: Drug
intervention name: Bilastine
description: 40mg
arm group label: 20 mg Bilastin
arm group label: Bilastin 40mg
arm group label: Bilastin 80mg
other name: Bilaxten
intervention type: Drug
intervention name: Bilastin
description: 80mg
arm group label: 20 mg Bilastin
arm group label: Bilastin 40mg
arm group label: Bilastin 80mg
other name: Bilaxten
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karsten Weller, MD
role: Principal Investigator
affiliation: Dpt. of Dermatology and Allergy , Charité
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: K. Weller
investigator title: PD
mesh term: Urticaria
mesh term: Chronic Urticaria