Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in Chinese pediatric patients with moderate-to-severe atopic dermatitis

    Summary
    EudraCT number
    		 2024-000402-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Oct 2024
    First version publication date
    10 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LPS17244
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05680298
    WHO universal trial number (UTN)
    		 U1111-1272-6639
    Sponsors
    Sponsor organisation name
    Sanofi (China) Investment Co., Ltd
    Sponsor organisation address
    Shanghai Branch, 19F Tower III, Jian’an Kerry Center, 1228 Middle Yan’an Road, Shanghai, China, 200040
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate changes in skin barrier function (SBF) with transepidermal water loss (TEWL) assessed after 5 skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate-to-severe atopic dermatitis (AD) treated with dupilumab.
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric participants. The parent(s) or guardian(s) as well as children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    34
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at a single center in China. A total of 39 participants were screened between 22 Feb 2023 and 30 Aug 2023, of which 5 were screen failures. Screen failures were mainly due to not meeting eligibility criteria and withdrawal of informed consent.

    Pre-assignment
    Screening details
    		 24 participants with AD and 10 healthy volunteers were successfully screened and enrolled in the study to investigate dupilumab’s effect on skin barrier function. Healthy participants arm did not receive any treatment and was considered as a reference comparator group.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Participants with AD
    Arm description
    		 Pediatric participants with moderate-to-severe AD received dupilumab subcutaneous (SC) injection depending on the body weight. Participants with baseline body weight of >=15 kilograms (kg) but <30 kg received an SC loading dose of dupilumab 600 milligrams (mg) on Day 1, followed by every 4-week SC dosing of dupilumab 300 mg from Week 4 up to Week 12. Participants with baseline body weight >=30 kg but <60 kg received an SC loading dose of dupilumab 400 mg on Day 1, followed by bi-weekly SC dosing of dupilumab 200 mg from Week 2 to Week 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dupilumab
    Investigational medicinal product code
    SAR231893, REGN668
    Other name
    Dupixent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dupilumab 200 mg or 300 mg was administered SC depending on the body weight as per the protocol.

    Arm title
    		 Healthy Participants
    Arm description
    		 Healthy volunteers matched to selected participants with AD for age, gender, location of targeted skin lesion area and study site received no treatment but were monitored in a similar way as AD participants.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Participants with AD Healthy Participants
    Started
    24
    10
    Completed
    22
    10
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Unspecified
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Participants with AD
    Reporting group description
    		 Pediatric participants with moderate-to-severe AD received dupilumab subcutaneous (SC) injection depending on the body weight. Participants with baseline body weight of >=15 kilograms (kg) but <30 kg received an SC loading dose of dupilumab 600 milligrams (mg) on Day 1, followed by every 4-week SC dosing of dupilumab 300 mg from Week 4 up to Week 12. Participants with baseline body weight >=30 kg but <60 kg received an SC loading dose of dupilumab 400 mg on Day 1, followed by bi-weekly SC dosing of dupilumab 200 mg from Week 2 to Week 14.

    Reporting group title
    Healthy Participants
    Reporting group description
    		 Healthy volunteers matched to selected participants with AD for age, gender, location of targeted skin lesion area and study site received no treatment but were monitored in a similar way as AD participants.

    Reporting group values
    		 Participants with AD Healthy Participants Total
    Number of subjects
    		 24 10 34
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.0 ( 1.71 ) 8.4 ( 2.27 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 11 6 17
        Male
    		 13 4 17

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Participants with AD
    Reporting group description
    		 Pediatric participants with moderate-to-severe AD received dupilumab subcutaneous (SC) injection depending on the body weight. Participants with baseline body weight of >=15 kilograms (kg) but <30 kg received an SC loading dose of dupilumab 600 milligrams (mg) on Day 1, followed by every 4-week SC dosing of dupilumab 300 mg from Week 4 up to Week 12. Participants with baseline body weight >=30 kg but <60 kg received an SC loading dose of dupilumab 400 mg on Day 1, followed by bi-weekly SC dosing of dupilumab 200 mg from Week 2 to Week 14.

    Reporting group title
    Healthy Participants
    Reporting group description
    		 Healthy volunteers matched to selected participants with AD for age, gender, location of targeted skin lesion area and study site received no treatment but were monitored in a similar way as AD participants.

    Primary: Percent Change From Baseline in TEWL After 5 STS Assessed on Lesional Skin at Week 16 in Participants With AD

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in TEWL After 5 STS Assessed on Lesional Skin at Week 16 in Participants With AD [1] [2]
    End point description
    TEWL is a non-invasive SBF test that measures perspiration/water loss through skin. TEWL measurements combined with STS measures SBF in predefined skin areas which are identified at Baseline. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Within the predefined lesional skin areas, 4 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. Baseline was defined as last available and evaluable value before and closest to first dose of study treatment. The intent-to-treat (ITT) population included all enrolled participants, who received at least 1 dose of study treatment and all enrolled healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures. Data was only collected for participants with AD as prespecified in protocol.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is analyzed only for 1 arm, no statistical analysis is added.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As the endpoint is analyzed only for 1 arm, no statistical analysis is added.
    End point values
    		 Participants with AD
    Number of subjects analysed
    24
    Units: percent change
        arithmetic mean (standard deviation)
    9.3534 ( 55.4986 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in TEWL Before and After 10, 15, 20 STS Assessed on Lesional Skin at Week 16 in Participants With AD

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in TEWL Before and After 10, 15, 20 STS Assessed on Lesional Skin at Week 16 in Participants With AD [3]
    End point description
    TEWL is a non-invasive SBF test that measures perspiration/water loss through skin. TEWL measurements combined with STS measures SBF in predefined skin areas which are identified at Baseline. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Within the predefined lesional skin areas, 4 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. Baseline was defined as last available and evaluable value before and closest to first dose of study treatment. The ITT population included all enrolled participants, who received at least 1 dose of study treatment and all enrolled healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures. Data was only collected for participants with AD as prespecified in protocol.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 16
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only the participants with AD were analyzed.
    End point values
    		 Participants with AD
    Number of subjects analysed
    24
    Units: percent change
    arithmetic mean (standard deviation)
        Before STS
    11.7785 ( 55.1387 )
        After 10 STS
    5.6879 ( 48.8550 )
        After 15 STS
    12.0645 ( 58.7468 )
        After 20 STS
    1.0684 ( 38.6738 )
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in TEWL Before and After 10, 15, 20 STS Assessed on Lesional Skin at Week 16 in Participants With AD

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in TEWL Before and After 10, 15, 20 STS Assessed on Lesional Skin at Week 16 in Participants With AD [4]
    End point description
    TEWL is a non-invasive SBF test that measures perspiration/water loss through skin. TEWL measurements combined with STS measures SBF in predefined skin areas which are identified at Baseline. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Within the predefined lesional skin areas, 4 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. Baseline was defined as last available and evaluable value before and closest to first dose of study treatment. The ITT population included all enrolled participants, who received at least 1 dose of study treatment and all enrolled healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures. Data was only collected for participants with AD as prespecified in protocol.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 16
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only the participants with AD were analyzed.
    End point values
    		 Participants with AD
    Number of subjects analysed
    24
    Units: absolute change
    arithmetic mean (standard deviation)
        Before STS
    0.4819 ( 14.5644 )
        After 10 STS
    0.3813 ( 20.9193 )
        After 15 STS
    -0.0396 ( 28.9110 )
        After 20 STS
    -4.5679 ( 32.1988 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    TEAEs were collected from first treatment administration up to Week 16
    Adverse event reporting additional description
    The Safety population included all enrolled participants, including participants who actually received at least 1 dose of study treatment or had at least 1 TEWL/STS assessment. TEAE data is reported only for participants with AD as healthy participants did not receive any study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Participants with AD
    Reporting group description
    		 Pediatric participants with moderate-to-severe AD received dupilumab SC injection depending on the body weight. Participants with baseline body weight of >=15 kg but <30 kg received an SC loading dose of dupilumab 600 mg on Day 1, followed by every 4-week SC dosing of dupilumab 300 mg from Week 4 up to Week 12. Participants with baseline body weight >=30 kg but <60 kg received an SC loading dose of dupilumab 400 mg on Day 1, followed by bi-weekly SC dosing of dupilumab 200 mg from Week 2 to Week 14.

    Serious adverse events
    		 Participants with AD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Participants with AD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 24 (16.67%)
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 15 15:48:01 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA