<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/NCT01673672</url>
  </required_header>
  <id_info>
    <org_study_id>CYT003-QbG10 12</org_study_id>
    <secondary_id>2012-003070-39</secondary_id>
    <nct_id>NCT01673672</nct_id>
  </id_info>
  <brief_title>CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Phase IIb Dose-Finding Study of CYT003-QbG10, a TLR9-Agonist, in Patients With Moderate to Severe Allergic Asthma Not Sufficiently Controlled on Current Standard Therapy (GINA Steps 3+4)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytos Biotechnology AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytos Biotechnology AG</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the therapeutic potential and safety/tolerability of&#xD;
      study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to&#xD;
      severe allergic asthma not sufficiently controlled on current standard controller therapy.&#xD;
&#xD;
      Altogether 360 patients randomized to 4 treatment groups will be included. The study compares&#xD;
      three dose strength with placebo. Each patient receives 7 injections of study drug or&#xD;
      undistinguishable placebo. Key outcome measures are patient reported parameters on their&#xD;
      asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    primary endpoint missed&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Questionnaire</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">365</enrollment>
  <condition>Moderate to Severe Allergic Asthma</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>7 weekly/biweekly injections of a placebo buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CYT003 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 weekly/biweekly injections of CYT003 low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CYT003 medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 weekly/biweekly injections of CYT003 medium dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CYT003 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 weekly/biweekly injections of CYT003 high dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CYT003</intervention_name>
    <description>7 subcutaneous injections, weekly/biweekly within 10 weeks</description>
    <arm_group_label>CYT003 high dose</arm_group_label>
    <arm_group_label>CYT003 low dose</arm_group_label>
    <arm_group_label>CYT003 medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>7 subcutaneous injections, weekly/biweekly within 10 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to provide written informed consent&#xD;
&#xD;
          -  Able and willing to complete all protocol requirements&#xD;
&#xD;
          -  Between 18 to 65 years of age&#xD;
&#xD;
          -  Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines&#xD;
             at step 3 or 4 of treatment who has been on stable controller therapy for at least 4&#xD;
             weeks, and symptoms are not sufficiently controlled with medium to high doses of&#xD;
             inhaled corticosteroid (ICS) (&gt;250 to ≤1000 µg/day fluticasone or equivalent) in&#xD;
             combination with or without long acting beta agonist (LABA), insufficient control will&#xD;
             be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses&#xD;
             of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers,&#xD;
             sustained release theophylline) are also acceptable, but NOT treatment with anti&#xD;
             immunoglobulin E (IgE) antibodies within the past 6 months&#xD;
&#xD;
          -  Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at&#xD;
             the screening and the baseline visits.&#xD;
&#xD;
          -  Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1&#xD;
             aero-allergen during the screening period&#xD;
&#xD;
          -  Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value&#xD;
&#xD;
          -  Reversibility of airway obstruction as demonstrated by:&#xD;
&#xD;
               -  FEV1 improvement by &gt;12% , and&#xD;
&#xD;
               -  By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a&#xD;
                  subject does not meet reversibility criteria at the screening visit,&#xD;
                  reversibility may be retested once prior to run-in as long as the test is&#xD;
                  performed at least 5 days prior to the beginning of the run-in phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet at least 80% compliance with completion of asthma symptoms and&#xD;
             medication diaries at the baseline visit, after initial instruction at the screening&#xD;
             visit and where necessary additional training at the 2-weeks run-in visit. . An&#xD;
             additional maximum 2-weeks training period may be added in such patients.&#xD;
&#xD;
          -  Treatment or hospitalization for asthma exacerbation within past 2 months.&#xD;
&#xD;
          -  Current use or use of systemic corticosteroids within past 2 months.&#xD;
&#xD;
          -  Current smokers.&#xD;
&#xD;
          -  Ex-smokers with a smoking history of &gt;10 pack years (1 package per day for 10 years).&#xD;
&#xD;
          -  Pregnancy or female planning to become pregnant during the study period.&#xD;
&#xD;
          -  Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT&#xD;
             completed within the last 3 years.&#xD;
&#xD;
          -  Treatment with IgE antibodies (Xolair®) within past 6 months.&#xD;
&#xD;
          -  Use of investigational unapproved drugs within 30 days or within 5 half-lives of the&#xD;
             investigational drug, whichever is longer, or planned use during the whole study&#xD;
             period.&#xD;
&#xD;
          -  Use of investigational biologics within the last 6 months.&#xD;
&#xD;
          -  Previous participation in a clinical study with a virus like particle (VLP) Qb-based&#xD;
             vaccine.&#xD;
&#xD;
          -  Possible dependency of the patient on sponsor and/or investigator.&#xD;
&#xD;
          -  Women of child bearing potential&#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>Thomas B Casale, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Creighton University, Omaha (NE)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Los Angeles, Huntington Beach, San Jose</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Walnut Creek, San Diego, Riverside, Fountain Valley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Colorado Springs, Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Miami, Tallahassee</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Ohmaha, Bellevue</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Eugene, Medford</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Providence, Warwick</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Spartanburg, Summerville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Kyjov</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Olomouc, Praha, Tabor, Ostrava, Hradec Kralove, Plzen, Brno</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Bad Woerishofen, Leipzig, Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Frankfurt aM, Delitzsch, Bonn, Berlin, Ruedersdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Szazhalombatta, Komaron</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Tatabanya, Szombathely, Csorna, Budapest, Balassagyarmat</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Haifa, Zerifin</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Rehovot, Petach Tikva, Ramat Gan, Jerusalem, Ashkelon, Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Slupsk, Lodz, Tarnow, Pila, Poznan, Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Tomsk,St.Petersburg,Yaroslavl,Novosibirsk,Smolensk,Barnaul</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Donetsk, Kharkiv, Kiew, Chernivtsi, Zaporizhzhya, Mykolayiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cytos Investigator Sites</name>
      <address>
        <city>Vinnytsya, Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>May 13, 2014</last_update_submitted>
  <last_update_submitted_qc>May 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT01673672
org study id: CYT003-QbG10 12
secondary id: 2012-003070-39
nct id: NCT01673672
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the therapeutic potential and safety/tolerability of
      study drug (CYT003) at 3 dose levels versus placebo in patients with persistent moderate to
      severe allergic asthma not sufficiently controlled on current standard controller therapy.

      Altogether 360 patients randomized to 4 treatment groups will be included. The study compares
      three dose strength with placebo. Each patient receives 7 injections of study drug or
      undistinguishable placebo. Key outcome measures are patient reported parameters on their
      asthma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Asthma Control Questionnaire
time frame: 1 year
arm group label: Placebo
arm group type: Placebo Comparator
description: 7 weekly/biweekly injections of a placebo buffer
arm group label: CYT003 low dose
arm group type: Experimental
description: 7 weekly/biweekly injections of CYT003 low dose
arm group label: CYT003 medium dose
arm group type: Experimental
description: 7 weekly/biweekly injections of CYT003 medium dose
arm group label: CYT003 high dose
arm group type: Experimental
description: 7 weekly/biweekly injections of CYT003 high dose
intervention type: Biological
intervention name: CYT003
description: 7 subcutaneous injections, weekly/biweekly within 10 weeks
arm group label: CYT003 high dose
arm group label: CYT003 low dose
arm group label: CYT003 medium dose
intervention type: Biological
intervention name: Placebo
description: 7 subcutaneous injections, weekly/biweekly within 10 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Thomas B Casale, Professor
role: Study Chair
affiliation: Creighton University, Omaha (NE)
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country: Czech Republic
country: Germany
country: Hungary
country: Israel
country: Poland
country: Russian Federation
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Asthma