<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/NCT02970331</url>
  </required_header>
  <id_info>
    <org_study_id>CLS008-CO-PR-001</org_study_id>
    <nct_id>NCT02970331</nct_id>
  </id_info>
  <brief_title>A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to &lt; 17 Years of Age With Plaque Psoriasis</brief_title>
  <official_title>A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to &lt; 17 Years of Age With Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maruho Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maruho Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, open-label study that will evaluate the safety/tolerability and&#xD;
      pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50&#xD;
      evaluable adolescents 12 to &lt; 17 years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    FDA requested us to stop the study&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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 incidence and severity of application site adverse events</measure>
    <time_frame>screening, weeks 0,2,4 and 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in incidence and severity of all AEs and their relationship to study drug</measure>
    <time_frame>screening, weeks 0,2,4 and 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline (pre-dose, Day 1) in safety laboratory parameters</measure>
    <time_frame>week 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)</measure>
    <time_frame>week 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of plasma concentrations of Pefcalcitol and its metabolites</measure>
    <time_frame>Day 1 and Day 15</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline</measure>
    <time_frame>week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline</measure>
    <time_frame>week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline</measure>
    <time_frame>week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline</measure>
    <time_frame>week 8</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>pefcalcitol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pefcalcitol 0.005% BID for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pefcalcitol ointment, 0.005%</intervention_name>
    <description>pefcalcitol ointment, 0.005%</description>
    <arm_group_label>pefcalcitol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or females 12 to &lt; 17 years of age&#xD;
&#xD;
          -  Have a confirmed diagnosis of plaque psoriasis&#xD;
&#xD;
          -  Negative pregnancy test&#xD;
&#xD;
          -  Group 1: Have plaque psoriasis with an IGA score of ≥ 2 (mild), with at least one&#xD;
             lesion ) and up to 20% Body Surface Area (BSA) involvement not including psoriasis on&#xD;
             the face and scalp&#xD;
&#xD;
          -  Group 2: Have plaque psoriasis with a IGA score of ≥ 2 (mild), with plaque psoriasis&#xD;
             involving at least 10% and up to 20% Body Surface Area (BSA) not including psoriasis&#xD;
             on the face and scalp&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy or intolerance to the study drug or other vitamin D3 analogs or any of&#xD;
             its components&#xD;
&#xD;
          -  history of or active generalized guttate, pustular or erythrodermic exfoliative&#xD;
             psoriasis&#xD;
&#xD;
          -  history or presence of contact dermatitis induced by a topical medicine or other&#xD;
             serious skin condition that is not well controlled&#xD;
&#xD;
          -  Use topical treatments known to have beneficial effects on psoriasis&#xD;
&#xD;
          -  Use phototherapy, oral corticosteroids, oral retinoid, oral&#xD;
             immunosuppressive/immunomodulate drugs, cytostatics, cyclosporine or methotrexate&#xD;
             within 30 days prior to the first dose of study drug&#xD;
&#xD;
          -  Use any approved biologics for psoriasis within 30 days or 5 half-lives of the&#xD;
             biologic before the first dose of study drug&#xD;
&#xD;
          -  Are treated with medications known to worsen psoriasis&#xD;
&#xD;
          -  Are taking an oral vitamin D&#xD;
&#xD;
          -  Are taking medications that affect calcium metabolism;&#xD;
&#xD;
          -  Subjects who have an average of three (3) QTcF measurements of &gt; 450 milliseconds as&#xD;
             shown on the ECG (Group 2 only);&#xD;
&#xD;
          -  Have clinically significant abnormal calcium homeostasis parameters at Visit 1;&#xD;
&#xD;
          -  Have clinically significant liver or renal dysfunction&#xD;
&#xD;
          -  Have any other clinically significant laboratory abnormalities, co-morbidities or&#xD;
             psychiatric conditions which that would place the subject at increased risk or would&#xD;
             confound the primary or secondary objectives of the study;&#xD;
&#xD;
          -  Use of any investigational drugs or biologics and/or participated in any clinical&#xD;
             trial within the last 60 days before the day of the first dose of study drug or are&#xD;
             taking part in a non-medication study which, that would interfere with study&#xD;
             compliance or outcome assessments;&#xD;
&#xD;
          -  Are pregnant or lactating females;&#xD;
&#xD;
          -  Have a known history of congenital or acquired immunodeficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</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>Psoriasis</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/NCT02970331
org study id: CLS008-CO-PR-001
nct id: NCT02970331
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A multi-center, open-label study that will evaluate the safety/tolerability and
      pharmacodynamics as well as the pharmacokinetic profile (sub-population analysis), in 50
      evaluable adolescents 12 to < 17 years of age.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in incidence and severity of application site adverse events
time frame: screening, weeks 0,2,4 and 8
measure: Change in incidence and severity of all AEs and their relationship to study drug
time frame: screening, weeks 0,2,4 and 8
measure: Changes from baseline (pre-dose, Day 1) in safety laboratory parameters
time frame: week 8
measure: Changes from baseline (pre-dose, Day 1) in calcium homeostasis parameters (total serum calcium and albumin-corrected calcium levels, plasma parathyroid hormone (PTH), and serum alkaline phosphatase)
time frame: week 8
measure: Determination of plasma concentrations of Pefcalcitol and its metabolites
time frame: Day 1 and Day 15
measure: Proportion of subjects with an IGA score of absence (0) or very mild (1) with a minimum of a 2-grade improvement from baseline
time frame: week 8
measure: Proportion of subjects who achieved an mPASI 75 from baseline (Week 0) to Week 8, or who achieved an mPASI 50 and a 5-point improvement in the CDLQI from baseline
time frame: week 8
measure: Proportion of subjects who achieved success in each of the three individual components of the mPASI (scaling, thickness and erythema) from baseline
time frame: week 8
measure: Proportion of subjects who achieved a 5-point improvement in the CDLQI from baseline
time frame: week 8
arm group label: pefcalcitol
arm group type: Experimental
description: pefcalcitol 0.005% BID for 8 weeks
intervention type: Drug
intervention name: pefcalcitol ointment, 0.005%
description: pefcalcitol ointment, 0.005%
arm group label: pefcalcitol
criteria: 
gender: All
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Psoriasis