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/NCT05991323</url>
    </required_header>
    <id_info>
      <org_study_id>OBS17721</org_study_id>
      <secondary_id>U1111-1288-8567</secondary_id>
      <nct_id>NCT05991323</nct_id>
    </id_info>
    <brief_title>Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study</brief_title>
    <acronym>GLOBOSPIN</acronym>
    <official_title>A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Regeneron Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sanofi</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 study is a prospective, multinational, observational investigation designed to elucidate&#xD;
        the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients&#xD;
        diagnosed with prurigo nodularis (PN).&#xD;
  &#xD;
        The primary objective of this study is to comprehensively characterize the real-world usage&#xD;
        of dupilumab for the management of PN.&#xD;
  &#xD;
        In addition to this, the study aims to achieve several secondary objectives, including a&#xD;
        detailed assessment of the medical history, socio-demographic and disease characteristics of&#xD;
        dupilumab-treated PN patients, as well as the evaluation of the long-term real-world&#xD;
        effectiveness of dupilumab therapy for PN.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The follow-up period will be 60 months or until death, loss to follow-up, or withdrawal,&#xD;
        whichever comes first.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">March 7, 2031</completion_date>
    <primary_completion_date type="Anticipated">March 9, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of reasons for dupilumab treatment initiation with the description of dosing</measure>
      <time_frame>At baseline</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of dupilumab treatment</measure>
      <time_frame>At baseline and in 60 months</time_frame>
      <description>The treatment duration will be measured from the start of dupilumab treatment until the date of discontinuation (e.g., lost to follow-up, death, or withdrawal).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of patients having dupilumab treatment modifications</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of reasons for dupilumab treatment modifications</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients who discontinued dupilumab</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of reasons for dupilumab treatment discontinuation</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of patients hospitalized due to PN</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Baseline Characteristics: PN-related medical history</measure>
      <time_frame>At baseline</time_frame>
      <description>(e.g., date of diagnosis, severity, comorbidities)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline Characteristics: Socio-demographics of PN patients</measure>
      <time_frame>At baseline</time_frame>
      <description>(e.g., month and year of birth (where allowed) or age, gender, race (if allowed), ethnicity (if allowed), Fitzpatrick skin type)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment</measure>
      <time_frame>At baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients using concomitant medication</measure>
      <time_frame>At baseline</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in WI-NRS</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 (&quot;No pain&quot;) to 10 (&quot;Worst pain imaginable&quot;). Scores range from 0 to10, with higher scores indicating greater pain intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in Skin Pain NRS</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 (&quot;No pain&quot;) to 10 (&quot;Worst pain imaginable&quot;). Scores range from 0 to10, with higher scores indicating greater pain intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in Sleep Disturbance NRS</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of &quot;Very much better (improved)&quot;</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with PGIC score of &quot;Very much better (improved)&quot; or &quot;Moderately better (improved)&quot;</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in PGIC</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of &quot;None&quot;</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with PGIS score of &quot;None&quot; or &quot;Mild&quot;</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in PGIS</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in Dermatology Life Quality Index (DLQI)</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The DLQI is designed to measure the health-related quality of life of adults with a skin disease. The DLQI consists of 10 questions related to the effect of skin disease over the past week. Overall scoring ranges from 0 to 30, with a high score indicative of a poorer Health-Related Quality of Life (HRQoL)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in Pruritus Activity Score (PAS)</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The modified PAS is a clinical-reported measure that evaluates the pruritic lesions. The modified questionnaire consists of five items: the type (visible lesions: item 1a; predominant lesions: item1b), estimated number (item 2), distribution (item 3), the representative body area and exact number of lesions (item 4), and the activity in terms of percentage of pruriginous lesions with excoriations/crusts on top (reflecting active scratching; item 5a) and the percentage of healed pruriginous lesions (reflecting healing of chronic prurigo; item 5b). The modified PAS will be completed based on the standard of care clinical assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in IGA-CPG Activity</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in IGA-CPG Stage</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in EQ-5D-5L</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean change in Hospital Anxiety and Depression Scale (HADS) total score</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The HADS is a Patient-Reported Outcomes (PRO) instrument for screening anxiety and depression in non-psychiatric populations. The HADS consists of 14 items, 7 each for anxiety and depression symptoms. Patients select a response from 0 to 3 for each item, based on how they have been feeling in the past week. Scores range from 0 to 21 for each subscale. HADS anxiety (HADS-A) and HADS depression (HADS-D) scores ≤ 7 indicate no clinically relevant symptoms (normal), 8 to 10 borderline abnormal (borderline case), and 11 to 21 abnormal (maximum 21) indicating more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire</measure>
      <time_frame>From baseline up to month 60</time_frame>
      <description>The Work Productivity and Activity Impairment General Health (WPAI-GH) is a 6-item Patient-Reported Outcomes (PRO) instrument that measures the effect of a condition on productivity during work and regular activities in the seven days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to health. WPAI-GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients experiencing AEs and SAEs</measure>
      <time_frame>From baseline up to month 60</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">550</enrollment>
    <condition>Prurigo Nodularis</condition>
    <arm_group>
      <arm_group_label>Patient with prurigo nodularis</arm_group_label>
      <description>Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dupilumab</intervention_name>
      <description>Injection solution; subcutaneous</description>
      <arm_group_label>Patient with prurigo nodularis</arm_group_label>
      <other_name>DUPIXENT</other_name>
      <other_name>SAR231893</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Eligible participants who initiate dupilumab treatment for prurigo nodularis (according to&#xD;
          the country-specific prescribing information)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 years or older at the time of informed consent.&#xD;
  &#xD;
            -  Physician decision to treat the patient with dupilumab for prurigo nodularis&#xD;
               (according to the country-specific prescribing information) made prior to and&#xD;
               independently of the patient's participation in the study.&#xD;
  &#xD;
            -  Patients able to understand and complete study-related questionnaires.&#xD;
  &#xD;
            -  Patients provide voluntary informed consent to participate in the study before&#xD;
               inclusion in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have a contraindication to dupilumab according to the country-specific&#xD;
               prescribing information label.&#xD;
  &#xD;
            -  Any condition that, in the opinion of the Investigator, may interfere with the&#xD;
               patient's ability to participate in the study, such as short life expectancy,&#xD;
               substance abuse, severe cognitive impairment, or other comorbidities that can&#xD;
               predictably prevent the patient from completing the schedule of visits and&#xD;
               assessments.&#xD;
  &#xD;
            -  Patients currently participating in any interventional clinical trial.&#xD;
  &#xD;
            -  Prior use of dupilumab within 6 months of the screening visit, or within 6 months of&#xD;
               the baseline visit if screening and baseline occur on the same day.&#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>Clinical Sciences &amp; Operations</last_name>
      <role>Study Director</role>
      <affiliation>Sanofi</affiliation>
    </overall_official>
    <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 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Prurigo</mesh_term>
      <mesh_term>Neurodermatitis</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/NCT05991323
  org study id: OBS17721
  secondary id: U1111-1288-8567
  nct id: NCT05991323
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective, multinational, observational investigation designed to elucidate
        the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients
        diagnosed with prurigo nodularis (PN).
  
        The primary objective of this study is to comprehensively characterize the real-world usage
        of dupilumab for the management of PN.
  
        In addition to this, the study aims to achieve several secondary objectives, including a
        detailed assessment of the medical history, socio-demographic and disease characteristics of
        dupilumab-treated PN patients, as well as the evaluation of the long-term real-world
        effectiveness of dupilumab therapy for PN.
  The follow-up period will be 60 months or until death, loss to follow-up, or withdrawal,
        whichever comes first.
  observational model: Case-Only
  time perspective: Prospective
  measure: Frequency of reasons for dupilumab treatment initiation with the description of dosing
  time frame: At baseline
  measure: Duration of dupilumab treatment
  time frame: At baseline and in 60 months
  description: The treatment duration will be measured from the start of dupilumab treatment until the date of discontinuation (e.g., lost to follow-up, death, or withdrawal).
  measure: Percentage of patients having dupilumab treatment modifications
  time frame: From baseline up to month 60
  measure: Frequency of reasons for dupilumab treatment modifications
  time frame: From baseline up to month 60
  measure: Proportion of patients who discontinued dupilumab
  time frame: From baseline up to month 60
  measure: Frequency of reasons for dupilumab treatment discontinuation
  time frame: From baseline up to month 60
  measure: Proportion of patients hospitalized due to PN
  time frame: From baseline up to month 60
  measure: Baseline Characteristics: PN-related medical history
  time frame: At baseline
  description: (e.g., date of diagnosis, severity, comorbidities)
  measure: Baseline Characteristics: Socio-demographics of PN patients
  time frame: At baseline
  description: (e.g., month and year of birth (where allowed) or age, gender, race (if allowed), ethnicity (if allowed), Fitzpatrick skin type)
  measure: Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment
  time frame: At baseline
  measure: Proportion of patients using concomitant medication
  time frame: At baseline
  measure: Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)
  time frame: From baseline up to month 60
  description: The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.
  measure: Mean change in WI-NRS
  time frame: From baseline up to month 60
  description: The WI-NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the intensity of their worst pruritus (itch) using the 0 to 10 WI-NRS. Scores range from 0 to 10, with higher scores indicating greater itch intensity.
  measure: Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)
  time frame: From baseline up to month 60
  description: The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.
  measure: Mean change in Skin Pain NRS
  time frame: From baseline up to month 60
  description: The Skin Pain NRS is a single-item Patient-Reported Outcomes (PRO). Patients indicate the intensity of their worst skin pain over the past 24 hours by selecting a number on the scale that ranges from 0 ("No pain") to 10 ("Worst pain imaginable"). Scores range from 0 to10, with higher scores indicating greater pain intensity.
  measure: Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)
  time frame: From baseline up to month 60
  description: The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.
  measure: Mean change in Sleep Disturbance NRS
  time frame: From baseline up to month 60
  description: The Sleep Disturbance NRS is a single-item Patient-Reported Outcomes (PRO). Patients will be asked to report the severity of their sleep disturbance using a 0 to 10 NRS. Scores range from 0 to10, with higher scores indicating worse sleep quality.
  measure: Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of "Very much better (improved)"
  time frame: From baseline up to month 60
  description: The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.
  measure: Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"
  time frame: From baseline up to month 60
  description: The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.
  measure: Mean change in PGIC
  time frame: From baseline up to month 60
  description: The PGIC is a 7-point scale to assess patient health and determine if there has been an improvement or decline in clinical status. Scores range from 1 to 7, with higher score indicating worse health status.
  measure: Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"
  time frame: From baseline up to month 60
  description: The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.
  measure: Proportion of patients with PGIS score of "None" or "Mild"
  time frame: From baseline up to month 60
  description: The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.
  measure: Mean change in PGIS
  time frame: From baseline up to month 60
  description: The PGIS is a one-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week. Scores range from 1 to 4, with higher score indicating worse symptom severity.
  measure: Mean change in Dermatology Life Quality Index (DLQI)
  time frame: From baseline up to month 60
  description: The DLQI is designed to measure the health-related quality of life of adults with a skin disease. The DLQI consists of 10 questions related to the effect of skin disease over the past week. Overall scoring ranges from 0 to 30, with a high score indicative of a poorer Health-Related Quality of Life (HRQoL)
  measure: Mean change in Pruritus Activity Score (PAS)
  time frame: From baseline up to month 60
  description: The modified PAS is a clinical-reported measure that evaluates the pruritic lesions. The modified questionnaire consists of five items: the type (visible lesions: item 1a; predominant lesions: item1b), estimated number (item 2), distribution (item 3), the representative body area and exact number of lesions (item 4), and the activity in terms of percentage of pruriginous lesions with excoriations/crusts on top (reflecting active scratching; item 5a) and the percentage of healed pruriginous lesions (reflecting healing of chronic prurigo; item 5b). The modified PAS will be completed based on the standard of care clinical assessment.
  measure: Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1
  time frame: From baseline up to month 60
  description: The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.
  measure: Mean change in IGA-CPG Activity
  time frame: From baseline up to month 60
  description: The IGA-CPG Activity is an instrument used to assess the overall activity of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.
  measure: Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1
  time frame: From baseline up to month 60
  description: The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.
  measure: Mean change in IGA-CPG Stage
  time frame: From baseline up to month 60
  description: The IGA-CPG Stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the Investigator. In this context, nodules, papules, plaques and other PN related lesions are defined as pruriginous lesions or chronic prurigo lesions. The instrument consists of a five-point scale ranging from 0 to 4. Higher scores indicate severe CPG.
  measure: Mean change in EQ-5D-5L
  time frame: From baseline up to month 60
  description: The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  measure: Mean change in Hospital Anxiety and Depression Scale (HADS) total score
  time frame: From baseline up to month 60
  description: The HADS is a Patient-Reported Outcomes (PRO) instrument for screening anxiety and depression in non-psychiatric populations. The HADS consists of 14 items, 7 each for anxiety and depression symptoms. Patients select a response from 0 to 3 for each item, based on how they have been feeling in the past week. Scores range from 0 to 21 for each subscale. HADS anxiety (HADS-A) and HADS depression (HADS-D) scores ≤ 7 indicate no clinically relevant symptoms (normal), 8 to 10 borderline abnormal (borderline case), and 11 to 21 abnormal (maximum 21) indicating more severe symptoms.
  measure: Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire
  time frame: From baseline up to month 60
  description: The Work Productivity and Activity Impairment General Health (WPAI-GH) is a 6-item Patient-Reported Outcomes (PRO) instrument that measures the effect of a condition on productivity during work and regular activities in the seven days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to health. WPAI-GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
  measure: Percentage of patients experiencing AEs and SAEs
  time frame: From baseline up to month 60
  arm group label: Patient with prurigo nodularis
  description: Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study
  intervention type: Drug
  intervention name: Dupilumab
  description: Injection solution; subcutaneous
  arm group label: Patient with prurigo nodularis
  other name: DUPIXENT
  other name: SAR231893
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Sciences & Operations
  role: Study Director
  affiliation: Sanofi
  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: Prurigo
  mesh term: Neurodermatitis
  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