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/NCT05979831</url>
    </required_header>
    <id_info>
      <org_study_id>DS2325-119</org_study_id>
      <secondary_id>2022-502853-32-00</secondary_id>
      <nct_id>NCT05979831</nct_id>
    </id_info>
    <brief_title>A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome</brief_title>
    <official_title>A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daiichi Sankyo, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daiichi Sankyo, 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>
        Netherton Syndrome (NS) is a severe rare disease characterized by generalized scaling,&#xD;
        erythema, and epidermal barrier defects. This study assessed the safety, pharmacokinetics&#xD;
        (PK), and efficacy of DS-2325a in patients with NS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will explore the safety, pharmacokinetics (PK), and early clinical signal efficacy&#xD;
        of DS-2325a in adult patients with NS. The primary objective of the study will be to explore&#xD;
        the safety and tolerability of DS-2325a in patients with NS by administering DS-2325a every&#xD;
        week for 12 consecutive weeks (Main Phase, which will be double-blind and during which some&#xD;
        participants will receive placebo as a control) and to confirm by administering for an&#xD;
        additional 24 weeks (Extension Phase, which will be open-label and during which all&#xD;
        participants will receive DS-2325a). Secondary objectives of the study will include exploring&#xD;
        the PK properties, efficacy, and immunogenicity of DS-2325a in patients with NS by&#xD;
        administering DS-2325a every week for 12 consecutive weeks (Main Phase) and to confirm by&#xD;
        administering for an additional 24 weeks (Extension Phase).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>Phase 1/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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events</measure>
      <time_frame>Screening up to Week 45 (end of study)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter Trough Concentration (Ctrough)</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter Area Under the Concentration-Time Curve Over a Dosing Interval at Steady State (AUCtau,ss)</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter Total Body Clearance (CL)</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter Apparent Total Body Clearance (CL/F)</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic Parameter Skin-to-Plasma DS2325a Concentration Ratio at Steady State (Ksp,ss)</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Ichthyosis Area Severity Index (IASI) Scores</measure>
      <time_frame>Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
      <description>The IASI measures the severity of the erythema (IASI-Erythema) and scaling (IASI-Scaling) based on a 4-point Likert scale where 0 (none) and 4 (very severe). The total IASI is determined by adding IASI-Erythema and IASI-Scaling scores. Higher scores indicate worse clinical outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Investigator Global Assessment (IGA) Scores</measure>
      <time_frame>Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
      <description>The IGA measures, using a 5-point scale (0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe) erythema, scaling, inflammatory papules or plaques, oozing, and lichenification. Higher scores indicate worse clinical outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Itch Numerical Rating Scale (NRS) Scores</measure>
      <time_frame>Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
      <description>The Itch NRS is a self-rated single item scale designed for assessing worst pruritus in the past 7 days. The scale utilizes an 11-point NRS, scored from 0 (no itch) to 10 (worst imaginable itch. Higher scores indicate worse clinical outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skindex-29 Responses</measure>
      <time_frame>Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
      <description>The Skindex-29 is a self-reported measure of skin-related symptoms, functioning, and emotional well-being, designed for use across dermatologic conditions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermatology Life Quality Index (DLQI) Questionnaire</measure>
      <time_frame>Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37</time_frame>
      <description>The DLQI is a self-reported measure of patients' perception of the impact of skin diseases on different aspects of their quality-of-life over the last week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Anti-Drug Antibodies Against DS-2325a</measure>
      <time_frame>Main Phase: Baseline and predose of Weeks 5 and 9; Extension Phase: Predose of Weeks 13, 17, 21, 25, 29, 33, 37, and 45</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Netherton Syndrome</condition>
    <arm_group>
      <arm_group_label>DS-2325a</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be randomized to receive a single initial (&quot;loading&quot;) intravenous (IV) dose of DS-2325a 1000 mg (Week 1) followed by weekly (&quot;maintenance&quot;) subcutaneous (SC) doses of 600 mg (Weeks 2-12) for a total of 12 weeks (Main Phase).&#xD;
  Participants will receive weekly DS-2325 SC doses of 600 mg for a total of 24 weeks (Extension Phase).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will be randomized to receive a single initial (&quot;loading&quot;) IV dose of placebo followed by weekly (&quot;maintenance&quot;) SC doses of placebo for a total of 12 weeks (Main Phase).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DS-2325a</intervention_name>
      <description>Main Phase: Loading IV infusion of 1000 mg followed by weekly SC doses of 600 mg&#xD;
  Extension Phase: Weekly SC doses of 600 mg</description>
      <arm_group_label>DS-2325a</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Main Phase: IV infusion followed by weekly SC doses</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female participants aged 18 to 65 years with clinical diagnosis of NS&#xD;
               including at least 3 out of the 4 following clinical criteria:&#xD;
  &#xD;
                 -  Neonatal erythroderma&#xD;
  &#xD;
                 -  Bamboo hair and/or alopecia&#xD;
  &#xD;
                 -  Chronic atopy specified as food allergy and/or asthma and/or rhino-conjunctivitis&#xD;
                    and/or eczema for at least 2 years&#xD;
  &#xD;
                 -  Ichthyosis linearis circumflexa or scaling erythroderma or equivalent&#xD;
  &#xD;
            -  Immunohistochemistry documentation of absence of LEKTI in the skin or confirmed SPINK5&#xD;
               gene mutations&#xD;
  &#xD;
            -  NS involvement of ≥20% of Body Surface Area (BSA)&#xD;
  &#xD;
            -  Patients must give written informed consent to participation in the study prior to&#xD;
               Screening&#xD;
  &#xD;
            -  Participants must be willing and able to understand and comply with study requirements&#xD;
  &#xD;
            -  Participants must be willing to have skin tape harvests collected from lesional and&#xD;
               nonlesional skin areas&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any skin disease that may interfere with the diagnosis or evaluation of NS&#xD;
  &#xD;
            -  Cutaneous infection requiring treatment with systemic antibiotics, antivirals,&#xD;
               antiparasitics, or antifungals within 2 weeks before Screening visit&#xD;
  &#xD;
            -  Concomitant systemic disease not controlled by treatment. Stability for 3 months prior&#xD;
               to Screening is required&#xD;
  &#xD;
            -  Kidney or liver disease with significant impairment of organ function (creatinine&#xD;
               clearance &lt;30 mL/min, calculated using the Cockcroft-Gault Equation, and Child-Pugh&#xD;
               Class C)&#xD;
  &#xD;
            -  Concomitant disease or condition that may interfere with, or treatment of which may&#xD;
               interfere with, the conduct of the study or that would, in the opinion of the&#xD;
               Investigator, pose an unacceptable risk to the patient in this study&#xD;
  &#xD;
            -  Any significant condition (eg, medical, psychiatric, or social) that according to&#xD;
               Investigator's judgment would prevent compliance with study protocol and full study&#xD;
               participation&#xD;
  &#xD;
            -  Known hypersensitivity to any ingredient of the study drug product&#xD;
  &#xD;
            -  Anticipation of the need for surgery or hospitalization during the study&#xD;
  &#xD;
            -  History of suicide attempt or suicidal ideation within 1 year prior to Screening&#xD;
  &#xD;
            -  History of substance abuse within 6 months prior to Screening or a positive urine drug&#xD;
               test at Screening. Medical marijuana may be used per discretion of the Investigator&#xD;
  &#xD;
            -  History or positive test result for human immunodeficiency virus (HIV) at Screening&#xD;
  &#xD;
            -  Active hepatitis B virus (HBV) infection, determined by positive test result for&#xD;
               hepatitis B surface antigen, at Screening&#xD;
  &#xD;
            -  Active hepatitis C virus (HCV) infection, determined as HCV ribonucleic acid (RNA)&#xD;
               above the limit of detection in patients with positive HCV antibody titer, at&#xD;
               Screening&#xD;
  &#xD;
            -  Use of topical drugs that may alter the course of NS (eg, topical corticosteroids and&#xD;
               topical calcineurin inhibitors) within 2 weeks before Screening or anticipation of&#xD;
               need to use these drugs during study drug&#xD;
  &#xD;
            -  Systemic treatment with corticosteroids, immunosuppressants, targeted therapeutics,&#xD;
               biologics, and IV Ig within 8 weeks before Screening&#xD;
  &#xD;
            -  Participation in any other clinical study or expanded access program with an&#xD;
               investigational drug or device within 4 weeks before Screening&#xD;
  &#xD;
            -  Suspected or confirmed COVID-19 within 4 weeks before or ongoing at Screening and&#xD;
               planned vaccination against COVID-19 during study drug&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Global Clinical Leader</last_name>
      <role>Study Director</role>
      <affiliation>Daiichi Sankyo, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daiichi Sankyo Contact for Clinical Information</last_name>
      <phone>908-992-6400</phone>
      <email>CTRinfo@dsi.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Saint Louis Hospital</name>
        <address>
          <city>Paris</city>
          <zip>75012</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Principal Investigator</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Netherton Syndrome</keyword>
    <keyword>DS-2325a</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Netherton Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
      <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
    </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/NCT05979831
  org study id: DS2325-119
  secondary id: 2022-502853-32-00
  nct id: NCT05979831
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Netherton Syndrome (NS) is a severe rare disease characterized by generalized scaling,
        erythema, and epidermal barrier defects. This study assessed the safety, pharmacokinetics
        (PK), and efficacy of DS-2325a in patients with NS.
  This study will explore the safety, pharmacokinetics (PK), and early clinical signal efficacy
        of DS-2325a in adult patients with NS. The primary objective of the study will be to explore
        the safety and tolerability of DS-2325a in patients with NS by administering DS-2325a every
        week for 12 consecutive weeks (Main Phase, which will be double-blind and during which some
        participants will receive placebo as a control) and to confirm by administering for an
        additional 24 weeks (Extension Phase, which will be open-label and during which all
        participants will receive DS-2325a). Secondary objectives of the study will include exploring
        the PK properties, efficacy, and immunogenicity of DS-2325a in patients with NS by
        administering DS-2325a every week for 12 consecutive weeks (Main Phase) and to confirm by
        administering for an additional 24 weeks (Extension Phase).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Number of Participants With Treatment-emergent Adverse Events
  time frame: Screening up to Week 45 (end of study)
  measure: Pharmacokinetic Parameter Trough Concentration (Ctrough)
  time frame: Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45
  measure: Pharmacokinetic Parameter Area Under the Concentration-Time Curve Over a Dosing Interval at Steady State (AUCtau,ss)
  time frame: Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45
  measure: Pharmacokinetic Parameter Total Body Clearance (CL)
  time frame: Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45
  measure: Pharmacokinetic Parameter Apparent Total Body Clearance (CL/F)
  time frame: Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45
  measure: Pharmacokinetic Parameter Skin-to-Plasma DS2325a Concentration Ratio at Steady State (Ksp,ss)
  time frame: Main Phase: Baseline and predose of Weeks 3, 5, 7, 9, and 11; Extension Phase: Predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, and 45
  measure: Mean Ichthyosis Area Severity Index (IASI) Scores
  time frame: Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
  description: The IASI measures the severity of the erythema (IASI-Erythema) and scaling (IASI-Scaling) based on a 4-point Likert scale where 0 (none) and 4 (very severe). The total IASI is determined by adding IASI-Erythema and IASI-Scaling scores. Higher scores indicate worse clinical outcome.
  measure: Mean Investigator Global Assessment (IGA) Scores
  time frame: Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
  description: The IGA measures, using a 5-point scale (0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe) erythema, scaling, inflammatory papules or plaques, oozing, and lichenification. Higher scores indicate worse clinical outcome.
  measure: Mean Itch Numerical Rating Scale (NRS) Scores
  time frame: Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
  description: The Itch NRS is a self-rated single item scale designed for assessing worst pruritus in the past 7 days. The scale utilizes an 11-point NRS, scored from 0 (no itch) to 10 (worst imaginable itch. Higher scores indicate worse clinical outcome.
  measure: Skindex-29 Responses
  time frame: Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
  description: The Skindex-29 is a self-reported measure of skin-related symptoms, functioning, and emotional well-being, designed for use across dermatologic conditions.
  measure: Dermatology Life Quality Index (DLQI) Questionnaire
  time frame: Screening; Observational: Predose of Weeks 1, 5, and 9; Main Phase: Baseline, predose of Weeks 3, 5, 7, 9, and 11; Extension Phase, predose of Weeks 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
  description: The DLQI is a self-reported measure of patients' perception of the impact of skin diseases on different aspects of their quality-of-life over the last week.
  measure: Number of Participants With Anti-Drug Antibodies Against DS-2325a
  time frame: Main Phase: Baseline and predose of Weeks 5 and 9; Extension Phase: Predose of Weeks 13, 17, 21, 25, 29, 33, 37, and 45
  arm group label: DS-2325a
  arm group type: Experimental
  description: Participants will be randomized to receive a single initial ("loading") intravenous (IV) dose of DS-2325a 1000 mg (Week 1) followed by weekly ("maintenance") subcutaneous (SC) doses of 600 mg (Weeks 2-12) for a total of 12 weeks (Main Phase).
  Participants will receive weekly DS-2325 SC doses of 600 mg for a total of 24 weeks (Extension Phase).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will be randomized to receive a single initial ("loading") IV dose of placebo followed by weekly ("maintenance") SC doses of placebo for a total of 12 weeks (Main Phase).
  intervention type: Drug
  intervention name: DS-2325a
  description: Main Phase: Loading IV infusion of 1000 mg followed by weekly SC doses of 600 mg
  Extension Phase: Weekly SC doses of 600 mg
  arm group label: DS-2325a
  intervention type: Other
  intervention name: Placebo
  description: Main Phase: IV infusion followed by weekly SC doses
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Global Clinical Leader
  role: Study Director
  affiliation: Daiichi Sankyo, Inc.
  last name: Daiichi Sankyo Contact for Clinical Information
  phone: 908-992-6400
  email: CTRinfo@dsi.com
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Netherton Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd description: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
  ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
  ipd url: https://vivli.org/ourmember/daiichi-sankyo/