<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/NCT01704534</url>
  </required_header>
  <id_info>
    <org_study_id>662507</org_study_id>
    <secondary_id>2011-002091-16</secondary_id>
    <nct_id>NCT01704534</nct_id>
  </id_info>
  <brief_title>A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa</brief_title>
  <acronym>HiTS</acronym>
  <official_title>A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen-Cilag B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether ustekinumab is effective in the treatment&#xD;
      of moderate to severe hidradenitis suppurativa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open label prospective study is performed to investigate the effectiveness and safety of&#xD;
      ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive&#xD;
      ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Change in Sartorius score</measure>
    <time_frame>76 weeks</time_frame>
    <description>Clinical response is defined as an improvement of the Sartorius score of at least 50%</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>Ustekinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <description>subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28</description>
    <arm_group_label>Ustekinumab</arm_group_label>
    <other_name>Stelara</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Hidradenitis suppurativa Hurley stage II or III&#xD;
&#xD;
          -  No response to conventional local and oral antibiotics, or immunnesuppressive&#xD;
             medication, or TNF-alpha inhibitors or surgery&#xD;
&#xD;
          -  The patient has to be able to complete a dutch questionnaire&#xD;
&#xD;
          -  Informed consent must be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to complete a Dutch questionnaire&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Active hepatitis B or C infection, HIV or tuberculosis&#xD;
&#xD;
          -  Treatment with biologics or other immunosuppressive medicine in the previous 3 months&#xD;
&#xD;
          -  Malignancies in the last 10 years with the exception of basal cell carcinoma&#xD;
&#xD;
          -  Demyelinating disorders&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  Known allergy to ustekinumab or to its preservatives&#xD;
&#xD;
          -  Live vaccins in the next 3 months Sever liver or renal failure&#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>Barbara Horváth, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Centre Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>February 12, 2015</last_update_submitted>
  <last_update_submitted_qc>February 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Barbara Horváth, Principal Investigator</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Hidradenitis suppurativa</keyword>
  <keyword>Acne ectopica</keyword>
  <keyword>Inverse acne</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>Stelara</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704534
org study id: 662507
secondary id: 2011-002091-16
nct id: NCT01704534
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether ustekinumab is effective in the treatment
      of moderate to severe hidradenitis suppurativa.
An open label prospective study is performed to investigate the effectiveness and safety of
      ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive
      ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Sartorius score
time frame: 76 weeks
description: Clinical response is defined as an improvement of the Sartorius score of at least 50%
arm group label: Ustekinumab
arm group type: Experimental
description: Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28
intervention type: Drug
intervention name: Ustekinumab
description: subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
arm group label: Ustekinumab
other name: Stelara
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Barbara Horváth, MD-PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Barbara Horváth, Principal Investigator
investigator title: MD PhD
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
mesh term: Ustekinumab