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/NCT06004986</url>
    </required_header>
    <id_info>
      <org_study_id>2023-504171-24-00</org_study_id>
      <nct_id>NCT06004986</nct_id>
    </id_info>
    <brief_title>DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema</brief_title>
    <acronym>DUPI REDUCE</acronym>
    <official_title>DUPI REDUCE Trial (DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema): a Multicenter, Low-intervention, Non-inferiority Randomized Controlled Trial, Embedded in the TREAT NL Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Prothya Biosolutions</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled trial is to study the (cost)effectiveness of extending&#xD;
        the intervals between dupilumab doses in patients with well-controlled atopic eczema, while&#xD;
        considering physician- and patient-reported disease severity, quality of life, and dupilumab&#xD;
        serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab&#xD;
        300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the&#xD;
        outcomes among these three groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While dupilumab is an effective treatment for atopic eczema, it is expensive and not without&#xD;
        the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The&#xD;
        currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks.&#xD;
        However, there is evidence that the intervals between doses could be extended in&#xD;
        disease-controlled patients while maintaining the same effectiveness. The objective of this&#xD;
        study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients&#xD;
        with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized&#xD;
        controlled trial will be performed, that is embedded in the TREatment of ATopic eczema&#xD;
        (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet&#xD;
        the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving&#xD;
        dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a&#xD;
        duration of 24 weeks, during which participants will have three hospital visits (at week 0,&#xD;
        week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve&#xD;
        assessments of both physician and patient-reported disease severity, quality of life and the&#xD;
        evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview&#xD;
        of the outcome measures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean EASI</measure>
      <time_frame>24 weeks</time_frame>
      <description>The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>EASI</measure>
      <time_frame>16 weeks</time_frame>
      <description>The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>vIGA-AD</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). The vIGA-AD can range from 0 to 4, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PtGA</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean patient self-reported Global Assessment of disease severity (PtGA). The PtGA can range from 0 to 4, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>POEM</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DLQI</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RECAP</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>The mean EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers. The EQ-5D-5L can range from 0 to 1, where a higher score indicates a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adapted iMCQ</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>Adapted iMTA Medical Consumption Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adapted iPCQ</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>Adapted iMTA Productivity Cost Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adapted iVICQ</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>Adapted iMTA Valuation of Informal Care Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dupilumab serum trough levels</measure>
      <time_frame>0 and 24 weeks</time_frame>
      <description>Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>16 and 24 weeks</time_frame>
      <description>Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Atopic Dermatitis</condition>
    <condition>Atopic Dermatitis Eczema</condition>
    <arm_group>
      <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Dupilumab s.c. 300 mg every 2 weeks for 24 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dupilumab 300 mg q3w</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dupilumab s.c. 300 mg every 3 weeks for 24 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dupilumab 300 mg q4w</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dupilumab s.c. 300 mg every 4 weeks for 24 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dupilumab</intervention_name>
      <description>Administering Dupilumab 300 mg at different dosing intervals.</description>
      <arm_group_label>Dupilumab 300 mg q2w</arm_group_label>
      <arm_group_label>Dupilumab 300 mg q3w</arm_group_label>
      <arm_group_label>Dupilumab 300 mg q4w</arm_group_label>
      <other_name>Dupixent</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject is an adult,&#xD;
  &#xD;
            -  Has a diagnosis of AE,&#xD;
  &#xD;
            -  Receives dupilumab 300 mg q2w for the treatment of AE,&#xD;
  &#xD;
            -  Has controlled disease according to the Treat-to-Target criteria,&#xD;
  &#xD;
            -  Agrees to the possibility that the dosage of dupilumab will be lowered,&#xD;
  &#xD;
            -  Has voluntarily signed and dated an informed consent prior to any study related&#xD;
               procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The subjects uses or initiates another systemic immunomodulating therapy for AE or&#xD;
               another diagnosis.&#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>Louise AA Gerbens, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Amsterdam University Medical Centers</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Phyllis I Spuls, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Amsterdam University Medical Centers</affiliation>
    </overall_official>
    <overall_official>
      <last_name>DirkJan Hijnen, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Phyllis I Spuls, MD PhD</last_name>
      <phone>+3120 566 9111</phone>
      <email>ph.i.spuls@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anouk GM Caron, MD</last_name>
      <phone>+31653704573</phone>
      <email>a.caron@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amsterdam University Medical Centers</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1105 AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anouk Caron, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Erasmus Medical Center</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>3015 GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>DirkJan Hijnen, MD PhD</last_name>
        <phone>+3110 704 0704</phone>
        <email>d.hijnen@erasmusmc.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Phyllis I. Spuls</investigator_full_name>
      <investigator_title>Prof. Dr. P.I. Spuls</investigator_title>
    </responsible_party>
    <keyword>Dupilumab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06004986
  org study id: 2023-504171-24-00
  nct id: NCT06004986
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this randomized controlled trial is to study the (cost)effectiveness of extending
        the intervals between dupilumab doses in patients with well-controlled atopic eczema, while
        considering physician- and patient-reported disease severity, quality of life, and dupilumab
        serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab
        300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the
        outcomes among these three groups.
  While dupilumab is an effective treatment for atopic eczema, it is expensive and not without
        the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The
        currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks.
        However, there is evidence that the intervals between doses could be extended in
        disease-controlled patients while maintaining the same effectiveness. The objective of this
        study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients
        with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized
        controlled trial will be performed, that is embedded in the TREatment of ATopic eczema
        (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet
        the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving
        dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a
        duration of 24 weeks, during which participants will have three hospital visits (at week 0,
        week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve
        assessments of both physician and patient-reported disease severity, quality of life and the
        evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview
        of the outcome measures.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Mean EASI
  time frame: 24 weeks
  description: The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
  measure: EASI
  time frame: 16 weeks
  description: The mean EASI (Eczema Area and Severity Index). The EASI can range from 0 to 72, where a lower score indicates a better outcome.
  measure: vIGA-AD
  time frame: 16 and 24 weeks
  description: The mean Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). The vIGA-AD can range from 0 to 4, where a lower score indicates a better outcome.
  measure: PtGA
  time frame: 16 and 24 weeks
  description: The mean patient self-reported Global Assessment of disease severity (PtGA). The PtGA can range from 0 to 4, where a lower score indicates a better outcome.
  measure: NRS
  time frame: 16 and 24 weeks
  description: The mean Peak Pruritus Numerical Rating Scale (NRS). The NRS can range from 0 to 10, where a lower score indicates a better outcome.
  measure: POEM
  time frame: 16 and 24 weeks
  description: The mean Patient-Oriented Eczema Measure (POEM). The POEM can range from 0 to 28, where a lower score indicates a better outcome.
  measure: DLQI
  time frame: 16 and 24 weeks
  description: The mean Dermatology Life Quality Index (DLQI). The DLQI can range from 0 to 30, where a lower score indicates a better outcome.
  measure: RECAP
  time frame: 16 and 24 weeks
  description: The mean Recap of atopic eczema (RECAP). The RECAP can range from 0 to 28, where a lower score indicates a better outcome.
  measure: EQ-5D-5L
  time frame: 16 and 24 weeks
  description: The mean EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers. The EQ-5D-5L can range from 0 to 1, where a higher score indicates a better outcome.
  measure: Adapted iMCQ
  time frame: 16 and 24 weeks
  description: Adapted iMTA Medical Consumption Questionnaire
  measure: Adapted iPCQ
  time frame: 16 and 24 weeks
  description: Adapted iMTA Productivity Cost Questionnaire
  measure: Adapted iVICQ
  time frame: 16 and 24 weeks
  description: Adapted iMTA Valuation of Informal Care Questionnaire
  measure: Dupilumab serum trough levels
  time frame: 0 and 24 weeks
  description: Dupilumab serum trough levels of 40 patients (n=20 in both the q3w and q4w arms)
  measure: Adverse events
  time frame: 16 and 24 weeks
  description: Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA)
  arm group label: Dupilumab 300 mg q2w
  arm group type: Active Comparator
  description: Dupilumab s.c. 300 mg every 2 weeks for 24 weeks.
  arm group label: Dupilumab 300 mg q3w
  arm group type: Experimental
  description: Dupilumab s.c. 300 mg every 3 weeks for 24 weeks.
  arm group label: Dupilumab 300 mg q4w
  arm group type: Experimental
  description: Dupilumab s.c. 300 mg every 4 weeks for 24 weeks.
  intervention type: Drug
  intervention name: Dupilumab
  description: Administering Dupilumab 300 mg at different dosing intervals.
  arm group label: Dupilumab 300 mg q2w
  arm group label: Dupilumab 300 mg q3w
  arm group label: Dupilumab 300 mg q4w
  other name: Dupixent
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Louise AA Gerbens, MD PhD
  role: Study Chair
  affiliation: Amsterdam University Medical Centers
  last name: Phyllis I Spuls, MD PhD
  role: Principal Investigator
  affiliation: Amsterdam University Medical Centers
  last name: DirkJan Hijnen, MD PhD
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  last name: Phyllis I Spuls, MD PhD
  phone: +3120 566 9111
  email: ph.i.spuls@amsterdamumc.nl
  last name: Anouk GM Caron, MD
  phone: +31653704573
  email: a.caron@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Prof. Dr. Phyllis I. Spuls
  investigator title: Prof. Dr. P.I. Spuls
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  sharing ipd: No