<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/NCT02197455</url>
  </required_header>
  <id_info>
    <org_study_id>1407014260</org_study_id>
    <nct_id>NCT02197455</nct_id>
  </id_info>
  <brief_title>Tofacitnib for the Treatment of Alopecia Areata and Variants</brief_title>
  <official_title>Tofacitnib for the Treatment of Alopecia Areata and Variants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus&#xD;
      kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia&#xD;
      areata and its variants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open-label pilot study. Participants will be treated with oral tofacitinib&#xD;
      for a maximum of 5 months. Participants will be evaluated at 3 months after completion of&#xD;
      therapy to evaluate for durability of response, late response and/or late adverse effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Mean Change in Severity of Alopecia Tool (SALT) Score</measure>
    <time_frame>3 months</time_frame>
    <description>SALT score range is from 0 (no hair loss) to 100 (100% hair loss)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Skindex 16 Scores</measure>
    <time_frame>3 months</time_frame>
    <description>Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Alopecia Areata (AA)</condition>
  <condition>Alopecia Totalis (AT)</condition>
  <condition>Alopecia Universalis (AU)</condition>
  <arm_group>
    <arm_group_label>Tofacitinib Administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib Administration</intervention_name>
    <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
    <arm_group_label>Tofacitinib Administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years old&#xD;
&#xD;
          -  Diagnosis of alopecia areata with &gt;50% scalp involvement, alopecia totalis, or&#xD;
             alopecia universalis&#xD;
&#xD;
          -  Hair loss present for at least 6 months&#xD;
&#xD;
          -  No treatment for alopecia areata in past 2 months&#xD;
&#xD;
          -  No evidence of hair regrowth&#xD;
&#xD;
          -  Females of childbearing potential must use birth control while taking the medication&#xD;
             and there must be a negative pregnancy test documented prior to starting the&#xD;
             medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years old&#xD;
&#xD;
          -  Patients have received treatment known to affect alopecia areata within 2 months of&#xD;
             enrolling in the study&#xD;
&#xD;
          -  Patients with a history of malignancy (except history of successfully treated basal&#xD;
             cell or squamous cell carcinoma of the skin)&#xD;
&#xD;
          -  Patients known to be HIV or hepatitis B or C positive&#xD;
&#xD;
          -  Patients with positive tuberculin skin test or positive QuantiFERON TB test&#xD;
&#xD;
          -  Patients with leukopenia or anemia&#xD;
&#xD;
          -  Patients with renal or hepatic impairment&#xD;
&#xD;
          -  Patients with peptic ulcer disease&#xD;
&#xD;
          -  Patients taking immunosuppressive medications, including but not limited to&#xD;
             prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus,&#xD;
             cyclosporine, or TNH-alpha inhibitors&#xD;
&#xD;
          -  Women of childbearing potential who are unable or unwilling to use birth control while&#xD;
             taking the medication&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brett King, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>January 30, 2017</results_first_submitted>
  <results_first_submitted_qc>March 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 4, 2017</results_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</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>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tofacitinib Administration</title>
          <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.&#xD;
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </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>Tofacitinib Administration</title>
          <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.&#xD;
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </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="37.9" spread="15.12"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Severity of Alopecia Tool (SALT) Score</title>
        <description>SALT score range is from 0 (no hair loss) to 100 (100% hair loss)</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib Administration</title>
            <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.&#xD;
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Severity of Alopecia Tool (SALT) Score</title>
          <description>SALT score range is from 0 (no hair loss) to 100 (100% hair loss)</description>
          <units>percent change in SALT score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Skindex 16 Scores</title>
        <description>Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib Administration</title>
            <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.&#xD;
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Skindex 16 Scores</title>
          <description>Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.3" lower_limit="-61.6" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Tofacitinib Administration</title>
          <description>5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.&#xD;
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.</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="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="18" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>cold</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>sinus infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>acne</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>night sweats</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </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>Brett King, MD</name_or_title>
      <organization>Yale Univ School of Medicine</organization>
      <phone>2037854092</phone>
      <email>brett.king@yale.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/NCT02197455
org study id: 1407014260
nct id: NCT02197455
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus
      kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia
      areata and its variants.
This study is an open-label pilot study. Participants will be treated with oral tofacitinib
      for a maximum of 5 months. Participants will be evaluated at 3 months after completion of
      therapy to evaluate for durability of response, late response and/or late adverse effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in Severity of Alopecia Tool (SALT) Score
time frame: 3 months
description: SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
measure: Mean Change in Skindex 16 Scores
time frame: 3 months
description: Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition
arm group label: Tofacitinib Administration
arm group type: Experimental
description: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
intervention type: Drug
intervention name: Tofacitinib Administration
description: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
arm group label: Tofacitinib Administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Brett King, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Tofacitinib
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 