<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/NCT03759197</url>
  </required_header>
  <id_info>
    <org_study_id>188-0551-305</org_study_id>
    <nct_id>NCT03759197</nct_id>
  </id_info>
  <brief_title>A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis</brief_title>
  <acronym>305</acronym>
  <official_title>A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Efficacy and Safety of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis Receiving Up to Four Weeks of Twice-Daily Treatment (Study 305)</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and&#xD;
      safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in&#xD;
      subjects with plaque psoriasis. Subjects will be instructed to apply the test article&#xD;
      (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment&#xD;
      Area twice daily for four weeks (Study Day 29), unless the investigator verifies the&#xD;
      subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks&#xD;
      (Study Day 15).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">August 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 27, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)</measure>
    <time_frame>Day 29</time_frame>
    <description>The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)</measure>
    <time_frame>Day 29</time_frame>
    <description>Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or &quot;average&quot; degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in pruritus score</measure>
    <time_frame>Day 29</time_frame>
    <description>The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents &quot;no itching&quot; and 10 represents &quot;worst itch imaginable.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGA &quot;treatment success&quot; at Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>The proportion of subjects with IGA &quot;treatment success&quot; at Day 15</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Drug: 188-0551 Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>188-0551 Spray</intervention_name>
    <description>Topical Spray containing active drug</description>
    <arm_group_label>Drug: 188-0551 Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Spray</intervention_name>
    <description>Topical Spray containing no active drug</description>
    <arm_group_label>Vehicle Spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is male or non-pregnant female and is at least 18 years of age at time of&#xD;
             informed consent.&#xD;
&#xD;
          2. Subject has provided written informed consent.&#xD;
&#xD;
          3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%&#xD;
             and no more than 10% body surface area (BSA) (excluding the face, scalp, groin,&#xD;
             axillae, and other intertriginous areas).&#xD;
&#xD;
          4. Subject has moderate to severe plaque psoriasis.&#xD;
&#xD;
          5. Subject is willing and able to apply the test article as directed, comply with study&#xD;
             instructions, and commit to all follow-up visits for the duration of the study.&#xD;
&#xD;
          6. Females must be post-menopausal , surgically sterile , or use an effective method of&#xD;
             birth control. , Women of childbearing potential (WOCBP) must have a negative urine&#xD;
             pregnancy test (UPT) at the Baseline Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.&#xD;
&#xD;
          2. Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.&#xD;
&#xD;
          3. Subject has palmar/plantar psoriasis.&#xD;
&#xD;
          4. Subject is pregnant, lactating, or is planning to become pregnant during the study.&#xD;
&#xD;
          5. Subject is currently enrolled in an investigational drug or device study.&#xD;
&#xD;
          6. Subject has been previously enrolled in this study and treated with a test article.&#xD;
&#xD;
        Other protocol defined inclusion or exclusion criteria assessed by the study staff may&#xD;
        apply.&#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>Tony Andrasfay</last_name>
    <role>Study Director</role>
    <affiliation>Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 06</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 09</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 07</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 02</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 04</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 01</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 05</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 08</name>
      <address>
        <city>Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 03</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 11</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 12</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 10</name>
      <address>
        <city>Fountain Inn</city>
        <state>South Carolina</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <disposition_first_submitted>February 18, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>February 18, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 25, 2020</disposition_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03759197
org study id: 188-0551-305
nct id: NCT03759197
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and
      safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in
      subjects with plaque psoriasis. Subjects will be instructed to apply the test article
      (188-0551 Spray or Vehicle Spray) to all psoriasis plaques within the designated Treatment
      Area twice daily for four weeks (Study Day 29), unless the investigator verifies the
      subject's psoriasis has cleared at Day 15, then test article application will be for 2 weeks
      (Study Day 15).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)
time frame: Day 29
description: The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).
measure: Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
time frame: Day 29
description: Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
measure: Change from Baseline in pruritus score
time frame: Day 29
description: The proportion of subjects with ≥4 point reduction from Baseline in the Itch Numeric Rating Scale (I-NRS) at Day 29. The I-NRS is based on a 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
measure: IGA "treatment success" at Day 15
time frame: Day 15
description: The proportion of subjects with IGA "treatment success" at Day 15
arm group label: Drug: 188-0551 Spray
arm group type: Experimental
description: 188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
arm group label: Vehicle Spray
arm group type: Placebo Comparator
description: Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks
intervention type: Drug
intervention name: 188-0551 Spray
description: Topical Spray containing active drug
arm group label: Drug: 188-0551 Spray
intervention type: Drug
intervention name: Vehicle Spray
description: Topical Spray containing no active drug
arm group label: Vehicle Spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tony Andrasfay
role: Study Director
affiliation: Therapeutics, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No