<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/NCT03817164</url>
  </required_header>
  <id_info>
    <org_study_id>THY-004</org_study_id>
    <nct_id>NCT03817164</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis</brief_title>
  <official_title>Multicenter, Randomized, Double-Blind, Sham-Controlled, Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thync Global, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ethica Clinical Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Thync Global, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study&#xD;
      assessing change in psoriasis severity and level of stress in patients with moderate&#xD;
      psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0,&#xD;
      2, 8, 12, and 16.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BSA x sPGA average percent change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Body Surface Area x Static Physician Global Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sPGA change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Static Physician Global Assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSA change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Body Surface Area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean PASI change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Psoriasis Area and Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI 50</measure>
    <time_frame>Week 16</time_frame>
    <description>Psoriasis Area and Severity Index - 50% reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI 75</measure>
    <time_frame>Week 16</time_frame>
    <description>Psoriasis Area and Severity Index - 75% reduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSSI change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Psoriasis Scalp Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QVAS change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Stress Level Quantified Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DLQI change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Dermatology Life Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PQOL-12 change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Psoriasis Quality of Life - 12 Item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADS change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus NRS change from Baseline</measure>
    <time_frame>Week 16</time_frame>
    <description>Pruritus Numerical Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)</measure>
    <time_frame>Week 16</time_frame>
    <description>Pruritus Numerical Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TSQM</measure>
    <time_frame>Week 16</time_frame>
    <description>Treatment Satisfaction Questionnaire for Medication</description>
  </secondary_outcome>
  <other_outcome>
    <measure>sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)</measure>
    <time_frame>Week 16</time_frame>
    <description>Static Physician Global Assessment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Active Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active stimulation pulsed current delivered over 15 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Autonomic Nerve Modulation - Active</intervention_name>
    <description>Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.</description>
    <arm_group_label>Active Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Autonomic Nerve Modulation - Control</intervention_name>
    <description>Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.</description>
    <arm_group_label>Control Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Outpatient, male or female of any race, 18 years of age or older. This study has no&#xD;
             pregnancy restrictions.&#xD;
&#xD;
          2. BSA* &lt;10% (excluding palms, soles, intertriginous and inverse areas).&#xD;
&#xD;
          3. sPGA* ≥3 (NOTE: sPGA score will be averaged across all lesions as opposed to grading&#xD;
             target lesions).&#xD;
&#xD;
          4. BSA x sPGA ≥12.&#xD;
&#xD;
          5. Subject diagnosed with chronic plaque psoriasis at least 6 months prior to screening.&#xD;
&#xD;
          6. Treatment-naïve of prohibited biological immunomodulating agents at the time of&#xD;
             screening, or decided to stop treatment with the biologic before screening for the&#xD;
             study.&#xD;
&#xD;
          7. Be able to follow study instructions and likely to complete all required visits.&#xD;
&#xD;
          8. Sign the IRB-approved ICF (which includes HIPAA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic&#xD;
             arthritis, or drug-induced psoriasis.&#xD;
&#xD;
          2. Subjects with plaque psoriasis on palms and soles at enrolment.&#xD;
&#xD;
          3. Subjects with plaque psoriasis on the back of the neck that would interfere with&#xD;
             device placement.&#xD;
&#xD;
          4. Evidence of skin conditions other than psoriasis that would interfere with&#xD;
             study-related evaluations of psoriasis.&#xD;
&#xD;
          5. Other than psoriasis, history of any clinically significant (as determined by&#xD;
             Investigator) or other major uncontrolled disease.&#xD;
&#xD;
          6. Psoriasis flare or rebound within 4 weeks of Visit 1 or spontaneously improving or&#xD;
             rapidly deteriorating plaque psoriasis during that same time period, as determined by&#xD;
             investigator.&#xD;
&#xD;
          7. Use of prohibited medications within the following washout periods:&#xD;
&#xD;
               -  Biological immunomodulating agents within the prior 12 weeks: etanercept&#xD;
                  (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab pegol&#xD;
                  (Cimzia), ixekizumab (Taltz)&#xD;
&#xD;
               -  Biological immunomodulating agents within the prior 24 weeks: ustekinumab&#xD;
                  (Stelara), secukinumab (Cosentyx), guselkumba (Tremfaya)&#xD;
&#xD;
               -  Oral drugs within the prior 4 weeks: apremilast, methotrexate, cyclosporine,&#xD;
                  corticosteroids&#xD;
&#xD;
               -  Oral drugs within the prior 12 weeks: acitretin&#xD;
&#xD;
               -  Photochemotherapy (PUVA) within the prior 4 weeks&#xD;
&#xD;
               -  Phototherapy (UVA/UVB) within the prior 2 weeks&#xD;
&#xD;
               -  Topical treatment likely to impact signs and symptoms of psoriasis (e.g.,&#xD;
                  corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors,&#xD;
                  salicylic acid, lactic acid, tar, urea, etc.) within the prior 2 weeks&#xD;
&#xD;
          8. Prolonged sun exposure or use of tanning booths or other source of UV radiation.&#xD;
&#xD;
          9. Medical or psychiatric conditions that may increase the risk associated with study&#xD;
             participation or may interfere with the interpretation of study results or compliance&#xD;
             of the subject and, in the opinion of the PI, would make the subject inappropriate for&#xD;
             entry into this study.&#xD;
&#xD;
         10. Clinically significant alcohol or drug abuse, or history of poor cooperation or&#xD;
             unreliability.&#xD;
&#xD;
         11. Exposure to any other investigational drug/device within 30 days prior to study entry.&#xD;
&#xD;
         12. Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and&#xD;
             above).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 1</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 5, 2019</last_update_submitted>
  <last_update_submitted_qc>July 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</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 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/NCT03817164
org study id: THY-004
nct id: NCT03817164
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study
      assessing change in psoriasis severity and level of stress in patients with moderate
      psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0,
      2, 8, 12, and 16.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: BSA x sPGA average percent change from Baseline
time frame: Week 16
description: Body Surface Area x Static Physician Global Assessment
measure: sPGA change from Baseline
time frame: Week 16
description: Static Physician Global Assessment
measure: BSA change from Baseline
time frame: Week 16
description: Body Surface Area
measure: Mean PASI change from Baseline
time frame: Week 16
description: Psoriasis Area and Severity Index
measure: PASI 50
time frame: Week 16
description: Psoriasis Area and Severity Index - 50% reduction
measure: PASI 75
time frame: Week 16
description: Psoriasis Area and Severity Index - 75% reduction
measure: PSSI change from Baseline
time frame: Week 16
description: Psoriasis Scalp Severity Index
measure: QVAS change from Baseline
time frame: Week 16
description: Stress Level Quantified Visual Analogue Scale
measure: DLQI change from Baseline
time frame: Week 16
description: Dermatology Life Quality Index
measure: PQOL-12 change from Baseline
time frame: Week 16
description: Psoriasis Quality of Life - 12 Item
measure: HADS change from Baseline
time frame: Week 16
description: Hospital Anxiety and Depression Scale
measure: Pruritus NRS change from Baseline
time frame: Week 16
description: Pruritus Numerical Rating Scale
measure: Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)
time frame: Week 16
description: Pruritus Numerical Rating Scale
measure: TSQM
time frame: Week 16
description: Treatment Satisfaction Questionnaire for Medication
measure: sPGA responder rate (i.e., proportion of subjects achieving sPGA 0 or 1)
time frame: Week 16
description: Static Physician Global Assessment
arm group label: Active Treatment
arm group type: Active Comparator
description: Active stimulation pulsed current delivered over 15 minutes.
arm group label: Control Treatment
arm group type: Sham Comparator
description: Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.
intervention type: Device
intervention name: Autonomic Nerve Modulation - Active
description: Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
arm group label: Active Treatment
intervention type: Device
intervention name: Autonomic Nerve Modulation - Control
description: Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
arm group label: Control Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No