<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/NCT03780166</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 50465-208</org_study_id>
    <secondary_id>Parsaclisib</secondary_id>
    <nct_id>NCT03780166</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris</brief_title>
  <official_title>A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of parsaclisib in&#xD;
      participants with mild to moderate pemphigus vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was withdrawn due to insufficient interest in study participation due to recent&#xD;
    approval in this rare condition.&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment-emergent adverse events</measure>
    <time_frame>Up to 20 weeks</time_frame>
    <description>Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of Parsaclisib</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Maximum observed concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of Parsaclisib</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Time to maximum concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of Parsaclisib</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Minimum observed concentration over the dose interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t of Parsaclisib</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Parsaclisib</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Apparent oral dose clearance.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pemphigus Vulgaris</condition>
  <arm_group>
    <arm_group_label>Parsaclisib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parsaclisib</intervention_name>
    <description>Parsaclisib administered orally once daily at the cohort-specified dose level.</description>
    <arm_group_label>Parsaclisib</arm_group_label>
    <other_name>INCB050465</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6&#xD;
             months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3;&#xD;
             Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal&#xD;
             lesions.&#xD;
&#xD;
          -  Disease progression after treatment with standard therapies that are known to confer&#xD;
             clinical benefit, or intolerant to treatment; there is no limit to the number of prior&#xD;
             treatment regimens.&#xD;
&#xD;
          -  Willingness to avoid pregnancy or fathering children.&#xD;
&#xD;
          -  If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during&#xD;
             the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding female.&#xD;
&#xD;
          -  Participants with pemphigus vulgaris who are treatment-naive.&#xD;
&#xD;
          -  Use of protocol-specified medications within defined periods before baseline.&#xD;
&#xD;
          -  Evidence or history of clinically significant infection or protocol-defined medical&#xD;
             conditions&#xD;
&#xD;
          -  Laboratory values outside the protocol-defined range at screening.&#xD;
&#xD;
          -  Known or suspected allergy to parsaclisib or any component of the study drug.&#xD;
&#xD;
          -  Known history of clinically significant drug or alcohol abuse in the last year before&#xD;
             baseline.&#xD;
&#xD;
          -  Inability or unlikeliness of the participant to comply with the dose schedule and&#xD;
             study evaluations, in the opinion of the investigator.&#xD;
&#xD;
          -  Any condition that would, in the investigator's judgment, interfere with full&#xD;
             participation in the study, including administration of study drug and attending&#xD;
             required study visits; pose a significant risk to the participant; or interfere with&#xD;
             interpretation of study data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Butler, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pemphigus vulgaris</keyword>
  <keyword>phosphatidylinositol 3-kinase delta</keyword>
  <keyword>immunoglobulin G autoantibodies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemphigus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03780166
org study id: INCB 50465-208
secondary id: Parsaclisib
nct id: NCT03780166
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess the safety and tolerability of parsaclisib in
      participants with mild to moderate pemphigus vulgaris.
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of treatment-emergent adverse events
time frame: Up to 20 weeks
description: Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
measure: Cmax of Parsaclisib
time frame: Up to 6 weeks
description: Maximum observed concentration.
measure: tmax of Parsaclisib
time frame: Up to 6 weeks
description: Time to maximum concentration.
measure: Cmin of Parsaclisib
time frame: Up to 6 weeks
description: Minimum observed concentration over the dose interval.
measure: AUC0-t of Parsaclisib
time frame: Up to 6 weeks
description: Area under the concentration-time curve from time = 0 to the last measurable concentration at time = t.
measure: CL/F of Parsaclisib
time frame: Up to 6 weeks
description: Apparent oral dose clearance.
arm group label: Parsaclisib
arm group type: Experimental
intervention type: Drug
intervention name: Parsaclisib
description: Parsaclisib administered orally once daily at the cohort-specified dose level.
arm group label: Parsaclisib
other name: INCB050465
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kathleen Butler, MD
role: Study Director
affiliation: Incyte Corporation
responsible party type: Sponsor
mesh term: Pemphigus
sharing ipd: No