xml: <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/NCT06028230</url>
    </required_header>
    <id_info>
      <org_study_id>ACT17841</org_study_id>
      <secondary_id>2023-504328-25</secondary_id>
      <nct_id>NCT06028230</nct_id>
    </id_info>
    <brief_title>A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa</brief_title>
    <acronym>ZEN</acronym>
    <official_title>A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kymera Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanofi</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>
        This is a parallel, Phase 2, 2-arm study to evaluate the efficacy, safety, PK, and biological&#xD;
        effects of SAR444656 compared with placebo in adult participants with moderate to severe HS&#xD;
        aged ≥18 to 70 years.&#xD;
  &#xD;
        Study details include:&#xD;
  &#xD;
          -  Screening period: up to 4 weeks (30 days)&#xD;
  &#xD;
          -  Treatment duration: up to 16 weeks&#xD;
  &#xD;
          -  Follow-up period: up to 4 weeks&#xD;
  &#xD;
          -  Total study duration: up to 24 weeks&#xD;
  &#xD;
          -  Number of visits: 14&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 29, 2023</start_date>
    <completion_date type="Anticipated">March 13, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 13, 2025</primary_completion_date>
    <phase>Phase 2</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>Percent change from baseline in total abscess and inflammatory nodule (AN) count</measure>
      <time_frame>Week 16</time_frame>
      <description>The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts count obtained as part of the HS clinical parameters.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving AN count ≤2</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants with improvement from baseline in Hurley Stage</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS</measure>
      <time_frame>Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the amount of analgesic</measure>
      <time_frame>Up to Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs</measure>
      <time_frame>Up to Week 20</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SAR444656 concentration</measure>
      <time_frame>Up to Week 16</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">99</enrollment>
    <condition>Hidradenitis Suppurativa</condition>
    <arm_group>
      <arm_group_label>SAR444656</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive SAR444656 orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo orally</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SAR444656 (KT-474)</intervention_name>
      <description>Oral Tablet</description>
      <arm_group_label>SAR444656</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Oral Tablet</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant with a history of signs and symptoms consistent with HS for at least 1&#xD;
               year prior to baseline.&#xD;
  &#xD;
            -  Participant must have HS lesions present in at least 2 distinct anatomic areas, one of&#xD;
               which must be Hurley Stage II or Hurley Stage III.&#xD;
  &#xD;
            -  Participant must have had an inadequate response to at least a 3-month treatment of an&#xD;
               oral antibiotic for treatment of HS as assessed by the Investigator.&#xD;
  &#xD;
            -  Participant must have a total AN count of ≥5 at the baseline visit.&#xD;
  &#xD;
            -  Participant must have a draining tunnel count of ≤20 at the baseline visit.&#xD;
  &#xD;
            -  Participant must have a CRP &gt;3 mg/L obtained at screening.&#xD;
  &#xD;
            -  Participant must be willing and able to complete the diary for the duration of the&#xD;
               study as required by the study protocol.&#xD;
  &#xD;
            -  Contraceptive use by men with a partner of childbearing potential and women should be&#xD;
               consistent with local regulations regarding the methods of contraception for those&#xD;
               participating in clinical studies.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant with any other active skin disease or condition (eg, bacterial, fungal, or&#xD;
               viral infection) that may interfere with assessment of HS.&#xD;
  &#xD;
            -  Any active or chronic infection requiring systemic treatment (eg, antibiotics,&#xD;
               antivirals, antifungals, antihelminthics) within 30 days prior to baseline.&#xD;
  &#xD;
            -  Known history of or suspected significant suppressed immune response, including&#xD;
               history of invasive opportunistic or helminthic infections despite infection&#xD;
               resolution or otherwise recurrent infections of abnormal frequency or prolonged&#xD;
               duration.&#xD;
  &#xD;
            -  Participant with history of solid organ transplant.&#xD;
  &#xD;
            -  Participant with history of splenectomy.&#xD;
  &#xD;
            -  Participant with history of any malignancy or lymphoproliferative disease, except if&#xD;
               the participant has been free from disease for ≥5 years. Successfully treated&#xD;
               non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized&#xD;
               carcinoma in situ of the cervix are allowed.&#xD;
  &#xD;
            -  Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other&#xD;
               than HS&#xD;
  &#xD;
            -  Participant with family history of sudden death or long QT syndrome.&#xD;
  &#xD;
            -  Participant with history of congenital or drug-induced long QT syndrome.&#xD;
  &#xD;
            -  Participant with congestive heart failure (New York Heart Association Class 2 to 4),&#xD;
               greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months,&#xD;
               known structural heart disease.&#xD;
  &#xD;
            -  Participant with history of any major cardiovascular events (eg, myocardial&#xD;
               infarction, unstable angina pectoris, coronary revascularization, stroke, or transient&#xD;
               ischemic attack) at any time prior to screening.&#xD;
  &#xD;
            -  Participant with history of ventricular fibrillation, ventricular tachycardia,&#xD;
               torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac&#xD;
               etiology.&#xD;
  &#xD;
            -  Participant with uncontrolled hypertension defined as consistent systolic blood&#xD;
               pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite&#xD;
               antihypertensive medication.&#xD;
  &#xD;
            -  Participant received prescription topical therapies for the treatment of HS within 14&#xD;
               days prior to the baseline visit.&#xD;
  &#xD;
            -  Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17&#xD;
               therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study&#xD;
               population. Furthermore, this 20% of biologic-experienced participants must fulfilled&#xD;
               one or more of the following conditions:&#xD;
  &#xD;
                 -  Discontinued due to treatment related toxicity and/or&#xD;
  &#xD;
                 -  Discontinuation is not related to lack or loss of therapeutic response.&#xD;
  &#xD;
          The above information is not intended to contain all considerations relevant to a&#xD;
          participant's potential participation in a clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
      <phone>800-633-1610</phone>
      <phone_ext>option 6</phone_ext>
      <email>Contact-US@sanofi.com</email>
    </overall_contact>
    <verification_date>August 2, 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Hidradenitis Suppurativa</mesh_term>
      <mesh_term>Hidradenitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028230
  org study id: ACT17841
  secondary id: 2023-504328-25
  nct id: NCT06028230
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a parallel, Phase 2, 2-arm study to evaluate the efficacy, safety, PK, and biological
        effects of SAR444656 compared with placebo in adult participants with moderate to severe HS
        aged ≥18 to 70 years.
  
        Study details include:
  
          -  Screening period: up to 4 weeks (30 days)
  
          -  Treatment duration: up to 16 weeks
  
          -  Follow-up period: up to 4 weeks
  
          -  Total study duration: up to 24 weeks
  
          -  Number of visits: 14
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Percent change from baseline in total abscess and inflammatory nodule (AN) count
  time frame: Week 16
  description: The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts count obtained as part of the HS clinical parameters.
  measure: Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)
  time frame: Week 16
  measure: Proportion of participants achieving AN count ≤2
  time frame: Week 16
  measure: Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
  time frame: Week 16
  measure: Proportion of participants with improvement from baseline in Hurley Stage
  time frame: Week 16
  measure: Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)
  time frame: Week 16
  measure: Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)
  time frame: Week 16
  measure: Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS
  time frame: Week 16
  measure: Change from baseline in the amount of analgesic
  time frame: Up to Week 16
  measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs
  time frame: Up to Week 20
  measure: Plasma SAR444656 concentration
  time frame: Up to Week 16
  arm group label: SAR444656
  arm group type: Experimental
  description: Participants will receive SAR444656 orally
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo orally
  intervention type: Drug
  intervention name: SAR444656 (KT-474)
  description: Oral Tablet
  arm group label: SAR444656
  intervention type: Drug
  intervention name: Placebo
  description: Oral Tablet
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Trial Transparency email recommended (Toll free number for US & Canada)
  phone: 800-633-1610
  phone ext: option 6
  email: Contact-US@sanofi.com
  responsible party type: Sponsor
  mesh term: Hidradenitis Suppurativa
  mesh term: Hidradenitis
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org