<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/NCT04414514</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT04414514</nct_id>
  </id_info>
  <brief_title>Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment</brief_title>
  <official_title>Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS&#xD;
      participants through inhibition of inflammatory activity.&#xD;
&#xD;
      Investigators aim to:&#xD;
&#xD;
        -  Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical&#xD;
           disease activity after 16 weeks of treatment.&#xD;
&#xD;
        -  Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through&#xD;
           translational analyses of skin biopsy samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary efficacy measure is the proportion of participants that achieve HiSCR at Week 16&#xD;
      with topical ruxolitinib 1.5% cream as compared to Week 0. The HiSCR is defined as an at&#xD;
      least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all&#xD;
      study body sites with no increase in abscess count and no increase in draining fistula count&#xD;
      relative to Baseline. The primary efficacy analysis will be carried out on all participants&#xD;
      who complete 16 weeks of treatment.&#xD;
&#xD;
      The research study consists of an 8 week screening with 16 weeks open-label portion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 13, 2022</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Open label</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HiSCR</measure>
    <time_frame>The primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.</time_frame>
    <description>The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>Open-label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 1.5% Cream</intervention_name>
    <description>Topical Ruxolitinib 1.5% Cream</description>
    <arm_group_label>Open-label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects age 12 years or older&#xD;
&#xD;
          2. Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules,&#xD;
             nodules, and/or abscess formation, single or multiple, with or without sinus tracts;&#xD;
&#xD;
          3. Subjects must have a diagnosis of HS for at least 3 months (90 days) prior to&#xD;
             Baseline;&#xD;
&#xD;
          4. Active HS lesions must be present in at least one distinct anatomic area;&#xD;
&#xD;
          5. Subject must have at least 3 total inflammatory lesions at the Baseline visit;&#xD;
&#xD;
          6. Subjects who had surgery in the treatment area, should be at least 3 months status&#xD;
             post the procedure (this applies to deroofing/marsupialization or excision, not&#xD;
             incision &amp; drainage)&#xD;
&#xD;
          7. Subject has a negative TB screening assessment (including a PPD test and/or&#xD;
             Quantiferon-TB Gold test equivalent) OR for patients with treated latent TB or&#xD;
             negative chest x-ray (CXR posterior-anterior [PA] and lateral view within prior 90&#xD;
             days) at Screening with documentation of treated latent tuberculosis (90 days of&#xD;
             treatment).&#xD;
&#xD;
          8. Medications can be continued if they have been at a stable dose for the requisite&#xD;
             duration and the dose is not increased during the study period:&#xD;
&#xD;
               -  Biologic medication (such as TNF, IL-12/23 or IL-17 inhibitors): Up to 30% of&#xD;
                  enrolled participants will be allowed to remain on a concurrent biologic at&#xD;
                  stable dosage if treated with a stable dose and frequency for 6 months or longer;&#xD;
&#xD;
               -  Oral antibiotic must be a stable dose and frequency for 28 days or longer;&#xD;
&#xD;
               -  Hormone-based therapy (birth control pills or spironolactone) must be a stable&#xD;
                  dose and frequency for 4 months or longer;&#xD;
&#xD;
               -  Oral retinoids must be on a stable dose and frequency for 90 days or longer;&#xD;
&#xD;
               -  Other topical therapy must be discontinued 14 days prior to the Baseline visit.&#xD;
&#xD;
               -  Child bearing potential: In addition, you must be willing to use a method of&#xD;
                  contraception during the study period and for 4 weeks after the last dose of&#xD;
                  study drug. (Note: Periodic abstinence calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods] and withdrawal are not acceptable as abstinence.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infection(s) unrelated to HS requiring treatment with:&#xD;
&#xD;
               -  intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30&#xD;
                  days prior to Baseline or;&#xD;
&#xD;
               -  oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior&#xD;
                  to Baseline, except as required as part of an anti-TB regimen;&#xD;
&#xD;
          2. Subject previously treated with a biologic medication but stopped due to lack of&#xD;
             effect/sufficient effect as deemed by the investigator.&#xD;
&#xD;
          3. Any other active skin disease or condition (e.g., bacterial, fungal or viral&#xD;
             infection) that may interfere with assessment of HS;&#xD;
&#xD;
          4. Pregnant (or considering becoming pregnant) or lactating females Note: Non child&#xD;
             bearing potential is defined as surgically sterile with a hysterectomy and/or&#xD;
             bilateral oophorectomy OR postmenopausal (defined as amenorrhea at least 12 months&#xD;
             before screening, confirmed by FSH levels at screening).&#xD;
&#xD;
          5. Clinically significant abnormal screening laboratory results as evaluated by the&#xD;
             Investigator.&#xD;
&#xD;
          6. Subject does not have reliable internet access for weekly electronic surveys;&#xD;
&#xD;
          7. Subject is considered by the Study Investigator, for any reason, to be an unsuitable&#xD;
             candidate for the study.&#xD;
&#xD;
          8. Excluded prohibited concomitant medication and procedures include: JAK inhibitors&#xD;
             (systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib,&#xD;
             lestaurtinib, and pacritinib) within 4 weeks of Screening ; surgical, laser, or IPL&#xD;
             intervention in area with HS lesion within 3 months of Screening, except for rescue&#xD;
             lesional treatment; systemic corticosteroid within 4 weeks; use of topical creams,&#xD;
             ointments, gels, and liquids except the study therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Joslyn Kirby, MD</last_name>
    <phone>717-531-1513</phone>
    <email>jkirby1@pennstatehealth.psu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Longenecker</last_name>
      <phone>717-531-5136</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Joslyn S. Kirby, MD</investigator_full_name>
    <investigator_title>Principal Investigator, Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04414514
org study id: 001
nct id: NCT04414514
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS
      participants through inhibition of inflammatory activity.

      Investigators aim to:

        -  Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical
           disease activity after 16 weeks of treatment.

        -  Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through
           translational analyses of skin biopsy samples.
The primary efficacy measure is the proportion of participants that achieve HiSCR at Week 16
      with topical ruxolitinib 1.5% cream as compared to Week 0. The HiSCR is defined as an at
      least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all
      study body sites with no increase in abscess count and no increase in draining fistula count
      relative to Baseline. The primary efficacy analysis will be carried out on all participants
      who complete 16 weeks of treatment.

      The research study consists of an 8 week screening with 16 weeks open-label portion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label
primary purpose: Treatment
masking: None (Open Label)
measure: HiSCR
time frame: The primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.
description: The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.
arm group label: Open-label
arm group type: Experimental
description: Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
intervention type: Drug
intervention name: Ruxolitinib 1.5% Cream
description: Topical Ruxolitinib 1.5% Cream
arm group label: Open-label
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Joslyn Kirby, MD
phone: 717-531-1513
email: jkirby1@pennstatehealth.psu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Joslyn S. Kirby, MD
investigator title: Principal Investigator, Associate Professor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: Undecided