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A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis (PELISTAD-EX2)

Primary Purpose

Dermatitis Atopic

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
dupilumab
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis Atopic

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age For new participants: ≥6 to <12 years of age (inclusive), at the time of signing the informed consent. For former PELISTAD participants: ≥6 to <14 years of age at the time of signing the informed consent. Type of participant and disease characteristics With AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. Applicable to new participants only: Investigator Global Assessment score of ≥3 (for US participants) or IGA ≥4 (for EU participants) at screening (on the 0 to 4 scale) depending on approved IGA label indication in the country. Applicable to new participants only: Have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0 to 3 scale of the ISS. Applicable to new participants only: Should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible. Willing to refrain from applying any topical medications on the target assessment areas (including lesional and non-lesional) throughout the study until EoS unless necessary to alleviate intolerable symptoms. Willing and able to comply with all clinic visits and study-related procedures. Weight -Body weight ≥15 kg at screening. - - - Exclusion Criteria: Medical conditions Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis). Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. Hypersensitivity to the active substance or to any of the excipients of dupilumab. Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. History of hypersensitivity reaction to skin tape or adhesives used in desquamme discs. Prior/concomitant therapy Treatment with any investigational medication other than dupilumab within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer. Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors or phototherapy within 4 weeks of baseline. Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the Investigator. Participants who received a live vaccine within 4 weeks of baseline. Prior/concurrent clinical study experience Current participation in another investigational or interventional clinical study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pediatric AD participants

    Arm Description

    Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.

    Outcomes

    Primary Outcome Measures

    Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
    Percent change from baseline in TEWL after 5 STS assessed on lesional skin.

    Secondary Outcome Measures

    Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.
    Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS, respectively, assessed on lesional skin at each study visit
    Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the study.

    Full Information

    First Posted
    August 1, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Sanofi
    Collaborators
    Regeneron Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05983068
    Brief Title
    A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
    Acronym
    PELISTAD-EX2
    Official Title
    A Two-year, Phase 4, Open-label, Single-arm Treatment Study to Evaluate the Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants (≥6 to <14 Years of Age) With Moderate-to-severe Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    May 29, 2026 (Anticipated)
    Study Completion Date
    August 7, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sanofi
    Collaborators
    Regeneron Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a 2-year, open-label, exploratory study with a 4-week screening period and a 104-week treatment phase designed to investigate dupilumab's long-term effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping (STS) in approximately 48 pediatric participants (aged ≥6 and <14 years at study entry) with moderate-to-severe AD. After the 104-week treatment phase and the last assessment at the EndofTreatment (EOT) visit (as planned at Week 104), participants will be followed-up for 4 weeks and an End-of-Study (EoS) by telephone at 4 weeks after the EOT visit will end the study for each participant. The maximum duration of the study per participant will be 112 weeks (including screening period). TEWL assessment in predefined lesional and non-lesional skin areas before and after STS will be conducted every 3 months (every 13 weeks) during the treatment period from Day 1 (Baseline/Week 0, Visit 2) to Week 104 (Visit 10/EoT).
    Detailed Description
    Study duration for each participant will be approximately 112 weeks, including: Screening period: Up to 4 weeks (Day -28 to Day -1) from signing the informed consent. Open-label dupilumab treatment period: 104 weeks (from Day 1/Week 0 to Week 104). Follow-up period: 4 weeks (safety follow-up phone visit at 4 weeks after the EoT visit).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dermatitis Atopic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pediatric AD participants
    Arm Type
    Experimental
    Arm Description
    Participants will receive dupilumab IMP according to the approved prescribing label in the country/region where the study is conducted.
    Intervention Type
    Drug
    Intervention Name(s)
    dupilumab
    Other Intervention Name(s)
    REGN668
    Intervention Description
    solution for injection; by subcutaneous (SC) injection
    Primary Outcome Measure Information:
    Title
    Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
    Description
    Percent change from baseline in TEWL after 5 STS assessed on lesional skin.
    Time Frame
    Baseline to Week 104
    Secondary Outcome Measure Information:
    Title
    Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS.
    Description
    Changes from baseline (percent and absolute) in TEWL after 5, 10, 15, and 20 STS, respectively, assessed on lesional skin at each study visit
    Time Frame
    Baseline to Week 104
    Title
    Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the study.
    Time Frame
    Baseline to Week 108

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age For new participants: ≥6 to <12 years of age (inclusive), at the time of signing the informed consent. For former PELISTAD participants: ≥6 to <14 years of age at the time of signing the informed consent. Type of participant and disease characteristics With AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening. Applicable to new participants only: Investigator Global Assessment score of ≥3 (for US participants) or IGA ≥4 (for EU participants) at screening (on the 0 to 4 scale) depending on approved IGA label indication in the country. Applicable to new participants only: Have active lesions on the upper limbs or lower limbs (including trunk, if needed), with severity for lesion erythema or edema/papulation ≥2 at screening on the 0 to 3 scale of the ISS. Applicable to new participants only: Should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible. Willing to refrain from applying any topical medications on the target assessment areas (including lesional and non-lesional) throughout the study until EoS unless necessary to alleviate intolerable symptoms. Willing and able to comply with all clinic visits and study-related procedures. Weight -Body weight ≥15 kg at screening. - - - Exclusion Criteria: Medical conditions Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the Investigator (ie, skin atrophy, ichthyosis, tinea infection, contact dermatitis). Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. Hypersensitivity to the active substance or to any of the excipients of dupilumab. Ocular disorder that in the opinion of the Investigator could adversely affect the individual's risk for study participation. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. History of hypersensitivity reaction to skin tape or adhesives used in desquamme discs. Prior/concomitant therapy Treatment with any investigational medication other than dupilumab within 16 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer. Systemic AD treatment, cyclosporine A (CsA), systemic corticosteroids, azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or Janus kinase (JAK) inhibitors or phototherapy within 4 weeks of baseline. Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the Investigator. Participants who received a live vaccine within 4 weeks of baseline. Prior/concurrent clinical study experience Current participation in another investigational or interventional clinical study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Trial Transparency email recommended (Toll free number for US & Canada)
    Phone
    800-633-1610
    Ext
    6#
    Email
    Contact-US@sanofi.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Sciences & Operations
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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

    Learn more about this trial

    A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

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