<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/NCT01698333</url>
  </required_header>
  <id_info>
    <org_study_id>122-0551-202</org_study_id>
    <nct_id>NCT01698333</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression</brief_title>
  <official_title>An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adrenal suppression effects of corticosteroids are among the most important safety concerns&#xD;
      for this group of products. This study is designed to determine the adrenal effects of the&#xD;
      investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of&#xD;
      the formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Hypothalamic-Pituitary-Adrenal (HPA) Axis Response</measure>
    <time_frame>Day 15</time_frame>
    <description>HPA axis response to stimulation by cosyntropin, dichotomized to &quot;normal&quot; and &quot;abnormal&quot;. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>122-0551</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>122-0551</intervention_name>
    <description>Applied twice daily for 2 weeks</description>
    <arm_group_label>122-0551</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a clinical diagnosis of stable plaque psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis&#xD;
&#xD;
          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis&#xD;
&#xD;
          -  Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy&#xD;
             within 30 days prior to initiation of treatment&#xD;
&#xD;
          -  Subject has used systemic corticosteroids or topical, inhaled, intranasal&#xD;
             corticosteroids within 30 days and 14 days, respectively, prior to study screening&#xD;
&#xD;
          -  Subject has had prolonged exposure to natural or artificial sources of ultraviolet&#xD;
             radiation within 30 days prior to initiation of treatment&#xD;
&#xD;
          -  Subject has used topical psoriatic therapy including tar, anthralin, retinoids,&#xD;
             vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment&#xD;
&#xD;
          -  Subject has used emollients/moisturizers on areas to be treated within one day prior&#xD;
             to initiation of treatment&#xD;
&#xD;
          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)&#xD;
&#xD;
          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or&#xD;
             angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has&#xD;
             not been stabilized&#xD;
&#xD;
          -  Subject is pregnant, nursing or planning a pregnancy during the study period&#xD;
&#xD;
          -  Subject is currently enrolled in an investigational drug, biologic or device study&#xD;
&#xD;
          -  Subject has received an investigational drug, biologic or an investigational device&#xD;
             within 30 days prior to study start&#xD;
&#xD;
          -  Subject has been previously enrolled in this study and treated with the test article&#xD;
&#xD;
          -  Subject has an irregular sleep schedule or works night shifts&#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>Syd Dromgoole, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anaheim Clinical Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutics Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>August 30, 2018</results_first_submitted>
  <results_first_submitted_qc>August 30, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 26, 2018</results_first_posted>
  <disposition_first_submitted>November 25, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>November 25, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 19, 2013</disposition_first_posted>
  <last_update_submitted>September 28, 2018</last_update_submitted>
  <last_update_submitted_qc>September 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>122-0551</keyword>
  <keyword>steroid</keyword>
  <keyword>HPA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: April 2012 to March 2013&#xD;
The location of clinical sites included private dermatology clinics and clinical research centers.</recruitment_details>
      <pre_assignment_details>All subjects who met the entry criteria were enrolled into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for 2 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </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>
      <population>The Intent-To-Treat (ITT) population included all participants enrolled in the study who were dispensed and applied test article at least once and had at least one follow-up visit after the Baseline visit (Visit 2). All 25 enrolled subjects were included in the ITT population.</population>
      <group_list>
        <group group_id="B1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for 2 weeks</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </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="50.7" spread="11.64"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hypothalamic-Pituitary-Adrenal (HPA) Axis Response</title>
        <description>HPA axis response to stimulation by cosyntropin, dichotomized to &quot;normal&quot; and &quot;abnormal&quot;. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.</description>
        <time_frame>Day 15</time_frame>
        <population>Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.</population>
        <group_list>
          <group group_id="O1">
            <title>122-0551</title>
            <description>122-0551: Applied twice daily for 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Hypothalamic-Pituitary-Adrenal (HPA) Axis Response</title>
          <description>HPA axis response to stimulation by cosyntropin, dichotomized to &quot;normal&quot; and &quot;abnormal&quot;. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.</description>
          <population>Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.</time_frame>
      <desc>The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>122-0551</title>
          <description>122-0551: Applied twice daily for 2 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v15.0</default_vocab>
        <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="8" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ACTH Stimulation Test Abnormal</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </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>The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public dissemination. The PI may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research</name_or_title>
      <organization>Therapeutics Inc.</organization>
      <phone>858-571-1800</phone>
      <email>clinicalresearch@therapeuticsinc.com</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/NCT01698333
org study id: 122-0551-202
nct id: NCT01698333
lead sponsor: 
has dmc: No
Adrenal suppression effects of corticosteroids are among the most important safety concerns
      for this group of products. This study is designed to determine the adrenal effects of the
      investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of
      the formulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
time frame: Day 15
description: HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.
arm group label: 122-0551
arm group type: Experimental
intervention type: Drug
intervention name: 122-0551
description: Applied twice daily for 2 weeks
arm group label: 122-0551
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Syd Dromgoole, PhD
role: Study Director
affiliation: Therapeutics, Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 