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/NCT06004050</url>
    </required_header>
    <id_info>
      <org_study_id>LP0133-2283</org_study_id>
      <nct_id>NCT06004050</nct_id>
    </id_info>
    <brief_title>A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults With Moderate to Severe Chronic Hand Eczema</brief_title>
    <official_title>A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice- Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults With Moderate to Severe Chronic Hand Eczema</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>LEO Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>LEO Pharma</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to evaluate the efficacy of twice-daily applications&#xD;
        of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult&#xD;
        participants with moderate to severe chronic hand eczema (CHE).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The trial comprises of a 16-week double-blind, treatment period, followed by an open label&#xD;
        treatment period of 36 weeks. In the double-blind treatment period two thirds of participants&#xD;
        will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle.&#xD;
        In the double-blind treatment period, participants will use delgocitinib twice a day. In the&#xD;
        open label period, participants will only use delgocitinib when needed (if their CHE flares&#xD;
        up). Some participants will also give blood samples at the start of the trial for&#xD;
        pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">September 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 26, 2024</primary_completion_date>
    <phase>Phase 3</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>Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hand Eczema Severity Index (HECSI)-90 at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Defined as at least a 90% improvement in HECSI score from baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HECSI-75 at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Defined as at least a 75% improvement in HECSI score from baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage Change in HECSI Score From Baseline to Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
      <description>HECSI score is used to rate the severity of hand eczema and ranges from 0 (lowest possible score) to 360 (highest possible score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Reduction of HESD Pain Score by ≥4 Points From Baseline at Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HESD Score From Baseline to Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HESD Itch Score From Baseline to Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HESD Pain Score From Baseline to Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hand Eczema Impact Scale (HEIS) Score</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HEIS Proximal Daily Activity Limitations (PDAL) Score</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16</measure>
      <time_frame>Baseline and Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Treatment-Emergent Adverse Events (AEs)</measure>
      <time_frame>From baseline to Week 16</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Treatment-Emergent AEs</measure>
      <time_frame>From Week 16 to Week 54</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Curve (AUC 0-12)</measure>
      <time_frame>Day 1 and Day 8 post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Serum Concentration (Cmax)</measure>
      <time_frame>Day 1 and Day 8 (0-12 hours post-dose)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Peak Drug Concentration (Tmax)</measure>
      <time_frame>Day 1 and Day 8 (0-12 hours post-dose)</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Chronic Hand Eczema</condition>
    <arm_group>
      <arm_group_label>Double-Blind Period: Twice-Daily Delgocitinib Cream</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 mg/g twice daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Double-Blind Period: Twice-Daily Vehicle Cream</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>20 mg/g twice daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Open Label Period: Twice-Daily Delgocitinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 mg/g twice daily</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Delgocitinib</intervention_name>
      <description>Topical administration</description>
      <arm_group_label>Double-Blind Period: Twice-Daily Delgocitinib Cream</arm_group_label>
      <arm_group_label>Open Label Period: Twice-Daily Delgocitinib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vehicle cream</intervention_name>
      <description>Topical administration</description>
      <arm_group_label>Double-Blind Period: Twice-Daily Vehicle Cream</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years or above at screening.&#xD;
  &#xD;
            2. Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or&#xD;
               returned twice or more within the last 12 months. Disease severity graded as moderate&#xD;
               to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3&#xD;
               or 4).&#xD;
  &#xD;
            3. HESD itch score (weekly average) of ≥4 points at baseline. The baseline weekly average&#xD;
               will be calculated from daily assessments of itch severity during the 7 days&#xD;
               immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 itch&#xD;
               scores out of the 7 days is required to calculate the baseline average score.&#xD;
  &#xD;
            4. Participants who have a documented recent history of inadequate response to treatment&#xD;
               with topical corticosteroids (TCS) (at any time within 1 year before the screening&#xD;
               visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due&#xD;
               to important side effects or safety risks).&#xD;
  &#xD;
                 -  Inadequate response is defined as a history of failure to achieve and maintain a&#xD;
                    low disease activity state (comparable to an IGACHE score of ≤2) despite&#xD;
                    treatment with a daily regimen of TCS of class III-IV (potent to very potent),&#xD;
                    applied for at least 28 days or for the maximum duration recommended by the&#xD;
                    product prescribing information, whichever is shorter.&#xD;
  &#xD;
                 -  Important side effects or safety risks are those that outweigh the potential&#xD;
                    treatment benefits and include intolerance to treatment, hypersensitivity&#xD;
                    reactions, and significant skin atrophy as assessed by the physician.&#xD;
  &#xD;
            5. Participants adherent to standard non-medicated skin care including avoidance of known&#xD;
               and relevant irritants and allergens.&#xD;
  &#xD;
            6. A woman of childbearing potential (WOCBP) must use an acceptable method of birth&#xD;
               control throughout the trial up until the last application of investigational&#xD;
               medicinal product (IMP).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Active atopic dermatitis (AD) requiring medical treatment in regions other than the&#xD;
               hands and feet.&#xD;
  &#xD;
            2. Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of&#xD;
               the body.&#xD;
  &#xD;
            3. Clinically significant infection (e.g. impetiginized hand eczema) on the hands.&#xD;
  &#xD;
            4. Clinically significant infection within 28 days prior to baseline which, in the&#xD;
               opinion of the investigator, may compromise the safety of the participant in the&#xD;
               trial, interfere with evaluation of the investigational medicinal product (IMP), or&#xD;
               reduce the participant's ability to participate in the trial. Clinically significant&#xD;
               infections are defined as:&#xD;
  &#xD;
                 -  A systemic infection.&#xD;
  &#xD;
                 -  A serious skin infection requiring parenteral (intravenous or intramuscular)&#xD;
                    antibiotics, antiviral, or antifungal medication.&#xD;
  &#xD;
            5. History of any known primary immunodeficiency disorder including a positive human&#xD;
               immunodeficiency virus (HIV) test at screening, or the participant taking&#xD;
               antiretroviral medications as determined by medical history and/or participant's&#xD;
               verbal report.&#xD;
  &#xD;
            6. History of cancer:&#xD;
  &#xD;
                 -  Participants who have had basal cell carcinoma, localized squamous cell carcinoma&#xD;
                    of the skin or in situ carcinoma of the cervix are eligible provided that the&#xD;
                    participant is in remission and curative therapy was completed at least 12 months&#xD;
                    prior to screening.&#xD;
  &#xD;
                 -  Participants who have had other malignancies are eligible provided that the&#xD;
                    participant is in remission and curative therapy was completed at least 5 years&#xD;
                    prior to screening.&#xD;
  &#xD;
            7. Any disorder which is not stable and could:&#xD;
  &#xD;
                 -  Affect the safety of the participant throughout the trial.&#xD;
  &#xD;
                 -  Impede the participant's ability to complete the trial. Examples include but are&#xD;
                    not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological,&#xD;
                    musculoskeletal, infectious, endocrine, metabolic, hematologic, immunological,&#xD;
                    and psychiatric disorders, and major physical impairment.&#xD;
  &#xD;
            8. Any abnormal finding which may:&#xD;
  &#xD;
                 -  Put the participant at risk because of their participation in the trial.&#xD;
  &#xD;
                 -  Influence the participant's ability to complete the trial. The abnormal finding&#xD;
                    must be clinically significant and observed during the screening period. Examples&#xD;
                    include abnormal findings in physical examination, vital signs, ECG, hematology,&#xD;
                    clinical chemistry, or urinalysis.&#xD;
  &#xD;
            9. Positive hepatitis B surface antigen or hepatitis C virus antibody serology at&#xD;
               screening.&#xD;
  &#xD;
           10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.0×ULN at&#xD;
               screening.&#xD;
  &#xD;
           11. Known or suspected hypersensitivity to any component(s) of the IMP.&#xD;
  &#xD;
           12. Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine,&#xD;
               azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), traditional&#xD;
               Chinese medicines (TCMs) (including herbals), or corticosteroids within 28 days prior&#xD;
               to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up&#xD;
               to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).&#xD;
  &#xD;
           13. Use of tanning beds, phototherapy (e.g. UVB, UVA1, PUVA), or bleach baths on the&#xD;
               handswithin 28 days prior to baseline.&#xD;
  &#xD;
           14. Previous or current treatment with Janus Kinase (JAK) inhibitors (including&#xD;
               delgocitinib/LEO 124249),systemic or topical.&#xD;
  &#xD;
           15. Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors,&#xD;
               pimecrolimus, tacrolimus), TCMs (including herbals), or TCS on the hands within 14&#xD;
               days prior to baseline.&#xD;
  &#xD;
           16. Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14&#xD;
               days prior to baseline.&#xD;
  &#xD;
           17. Other transdermal or cutaneously applied therapy on the hands (except for the use of&#xD;
               participant's own emollients) within 7 days prior to baseline.&#xD;
  &#xD;
           18. Cutaneously applied treatments in regions other than the hands, which could interfere&#xD;
               with clinical trial evaluations or pose a safety concern within 7 days prior to&#xD;
               baseline.&#xD;
  &#xD;
           19. Treatment with any marketed biological therapy or investigational biologic agents&#xD;
               (including immunoglobulin, anti-IgE, and dupilumab):&#xD;
  &#xD;
               • Any cell-depleting agents including but not limited to rituximab: within 6 months&#xD;
               prior to baseline, or until lymphocyte count returns to normal, whichever is longer.&#xD;
  &#xD;
               • Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to&#xD;
               baseline.&#xD;
  &#xD;
           20. Treatment with any non-marketed drug substance (that is, an agent that has not yet&#xD;
               been made available for clinical use following registration) within the last 28 days&#xD;
               prior to baseline or 5 half-lives, whichever is longer.&#xD;
  &#xD;
           21. Major surgery within 8 weeks prior to screening, or planned in-patient surgery or&#xD;
               hospitalization during the trial period.&#xD;
  &#xD;
           22. Current participation in any other interventional clinical trial.&#xD;
  &#xD;
           23. Previously randomized in this clinical trial.&#xD;
  &#xD;
           24. Concurrent skin diseases on the hands, e.g. tinea manuum.&#xD;
  &#xD;
           25. Active psoriasis on any part of the body.&#xD;
  &#xD;
           26. Current or recent chronic alcohol or drug abuse, or any other condition associated&#xD;
               with poor compliance as judged by the investigator.&#xD;
  &#xD;
           27. Employees of the trial site, or any other individuals directly involved with the&#xD;
               planning or conduct of the trial, or immediate family members of such individuals.&#xD;
  &#xD;
           28. Participants who are legally institutionalized.&#xD;
  &#xD;
           29. Women who are pregnant or lactating.&#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>Medical Expert</last_name>
      <role>Study Director</role>
      <affiliation>LEO Pharma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Disclosure</last_name>
      <phone>(+1) 877-557-1168</phone>
      <email>clinicaltrialscontactus@leo-pharma.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dermatologic Disease</keyword>
    <keyword>Dermatology</keyword>
    <keyword>Eczema</keyword>
    <keyword>Chronic Hand Eczema</keyword>
    <keyword>Delgocitinib</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_access_criteria>Data sharing is subject to approved scientifically sound research proposal and signed data agreement</ipd_access_criteria>
      <ipd_url>http://leopharmatrials.com/for-professionals</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/NCT06004050
  org study id: LP0133-2283
  nct id: NCT06004050
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to evaluate the efficacy of twice-daily applications
        of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult
        participants with moderate to severe chronic hand eczema (CHE).
  The trial comprises of a 16-week double-blind, treatment period, followed by an open label
        treatment period of 36 weeks. In the double-blind treatment period two thirds of participants
        will be randomly assigned to receive delgocitinib and one third will receive placebo/vehicle.
        In the double-blind treatment period, participants will use delgocitinib twice a day. In the
        open label period, participants will only use delgocitinib when needed (if their CHE flares
        up). Some participants will also give blood samples at the start of the trial for
        pharmacokinetic measurements. Participants will visit the clinic every 4 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
  time frame: Week 16
  description: The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.
  measure: Hand Eczema Severity Index (HECSI)-90 at Week 16
  time frame: Week 16
  description: Defined as at least a 90% improvement in HECSI score from baseline.
  measure: HECSI-75 at Week 16
  time frame: Week 16
  description: Defined as at least a 75% improvement in HECSI score from baseline.
  measure: Percentage Change in HECSI Score From Baseline to Week 16
  time frame: Baseline and Week 16
  description: HECSI score is used to rate the severity of hand eczema and ranges from 0 (lowest possible score) to 360 (highest possible score).
  measure: Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16
  time frame: Baseline and Week 16
  measure: Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16
  time frame: Baseline and Week 16
  measure: Number of Participants With Reduction of HESD Pain Score by ≥4 Points From Baseline at Week 16
  time frame: Baseline and Week 16
  measure: Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
  time frame: Baseline and Week 16
  measure: Change in HESD Score From Baseline to Week 16
  time frame: Baseline and Week 16
  measure: Change in HESD Itch Score From Baseline to Week 16
  time frame: Baseline and Week 16
  measure: Change in HESD Pain Score From Baseline to Week 16
  time frame: Baseline and Week 16
  measure: Change in Hand Eczema Impact Scale (HEIS) Score
  time frame: Baseline and Week 16
  measure: Change in HEIS Proximal Daily Activity Limitations (PDAL) Score
  time frame: Baseline and Week 16
  measure: Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
  time frame: Baseline and Week 16
  measure: Number of Treatment-Emergent Adverse Events (AEs)
  time frame: From baseline to Week 16
  measure: Number of Treatment-Emergent AEs
  time frame: From Week 16 to Week 54
  measure: Area Under the Curve (AUC 0-12)
  time frame: Day 1 and Day 8 post-dose
  measure: Maximum Serum Concentration (Cmax)
  time frame: Day 1 and Day 8 (0-12 hours post-dose)
  measure: Time to Peak Drug Concentration (Tmax)
  time frame: Day 1 and Day 8 (0-12 hours post-dose)
  arm group label: Double-Blind Period: Twice-Daily Delgocitinib Cream
  arm group type: Experimental
  description: 20 mg/g twice daily
  arm group label: Double-Blind Period: Twice-Daily Vehicle Cream
  arm group type: Placebo Comparator
  description: 20 mg/g twice daily
  arm group label: Open Label Period: Twice-Daily Delgocitinib
  arm group type: Experimental
  description: 20 mg/g twice daily
  intervention type: Drug
  intervention name: Delgocitinib
  description: Topical administration
  arm group label: Double-Blind Period: Twice-Daily Delgocitinib Cream
  arm group label: Open Label Period: Twice-Daily Delgocitinib
  intervention type: Other
  intervention name: Vehicle cream
  description: Topical administration
  arm group label: Double-Blind Period: Twice-Daily Vehicle Cream
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Medical Expert
  role: Study Director
  affiliation: LEO Pharma
  last name: Clinical Disclosure
  phone: (+1) 877-557-1168
  email: clinicaltrialscontactus@leo-pharma.com
  responsible party type: Sponsor
  mesh term: Eczema
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd access criteria: Data sharing is subject to approved scientifically sound research proposal and signed data agreement
  ipd url: http://leopharmatrials.com/for-professionals