Clinical Trial Results:
Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in Chinese patients with moderate to severe atopic dermatitis
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Summary
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EudraCT number |
2024-000164-37 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
25 Jan 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jul 2024
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First version publication date |
11 Jul 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LPS17250
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05624112 | ||
WHO universal trial number (UTN) |
U1111-1272-6687 | ||
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Sponsors
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Sponsor organisation name |
Sanofi (China) Investment Co., Ltd
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Sponsor organisation address |
19F Tower III, Jing’an Kerry Center, 1228 Middle Yan’an Road, Shanghai, China, 200000
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Public contact |
Trial Transparency Team, Sanofi (China) Investment Co., Ltd, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi (China) Investment Co., Ltd, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Mar 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jan 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after 5 skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis (AD) treated with dupilumab.
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Protection of trial subjects |
Participants were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the participant and considering the local culture. During the course of the trial, participants were provided with individual participant cards indicating the nature of the trial the participant is participating, contact details and any information needed in the event of a medical emergency.
Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Nov 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
China: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
11
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Adults (18-64 years) |
33
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at a single center in China. A total of 44 participants were screened between 25 November 2022 and 08 September 2023. There was no screening failure. | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 44 participants were enrolled in the study. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Atopic Dermatitis Participants | |||||||||||||||
Arm description |
Participants aged >=12 to <18 years and body weight of <60 kilogram (kg) received dupilumab first dose on Day 1, followed by dupilumab second dose every second week (Q2W) for 16 weeks. Participants aged >=12 to <18 years and body weight of >=60 kg received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. Participants aged >=18 years received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Dupilumab
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Investigational medicinal product code |
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Other name |
Dupixent®
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Dupilumab was administered by subcutaneous injection at sites alternating between the upper thighs, 4 quadrants of the abdomen or the upper arms, so that the same site was not injected twice during consecutive administrations.
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Arm title
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Healthy Participants | |||||||||||||||
Arm description |
Participants didn't receive any treatment. | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Atopic Dermatitis Participants
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Reporting group description |
Participants aged >=12 to <18 years and body weight of <60 kilogram (kg) received dupilumab first dose on Day 1, followed by dupilumab second dose every second week (Q2W) for 16 weeks. Participants aged >=12 to <18 years and body weight of >=60 kg received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. Participants aged >=18 years received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Healthy Participants
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Reporting group description |
Participants didn't receive any treatment. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atopic Dermatitis Participants
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Reporting group description |
Participants aged >=12 to <18 years and body weight of <60 kilogram (kg) received dupilumab first dose on Day 1, followed by dupilumab second dose every second week (Q2W) for 16 weeks. Participants aged >=12 to <18 years and body weight of >=60 kg received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. Participants aged >=18 years received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. | ||
Reporting group title |
Healthy Participants
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Reporting group description |
Participants didn't receive any treatment. | ||
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End point title |
Atopic Dermatitis Participants: Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping on Lesional Skin at Week 16 [1] [2] | ||||||||
End point description |
The TEWL is commonly used for physiologic assessment of skin barrier function. The TEWL measurements have also been combined with skin barrier perturbation using STS to measure skin barrier function and integrity. The intent-to-treat (ITT) population included all enrolled participants, including participants who received at least 1 dose of study drug and healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1) and Week 16
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| 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 was analyzed only in participants with atopic dermatitis reporting group, the statistical comparison can't be performed. [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: Only participants with atopic dermatitis were analyzed for the primary endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Atopic Dermatitis Participants: Percent Change From Baseline in Transepidermal Water Loss Before and After 10, 15, and 20 Skin Tape Stripping on Lesional Skin at Week 16 [3] | ||||||||||||||||
End point description |
The TEWL is commonly used for physiologic assessment of skin barrier function. The TEWL measurements have also been combined with skin barrier perturbation using STS to measure skin barrier function and integrity. The ITT population included all enrolled participants, including participants who received at least 1 dose of study drug and healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Week 16
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| 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 participants with atopic dermatitis were analyzed for the secondary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Atopic Dermatitis Participants: Absolute Change From Baseline in Transepidermal Water Loss Before and After 10, 15, and 20 Skin Tape Stripping on Lesional Skin at Week 16 [4] | ||||||||||||||||
End point description |
The TEWL is commonly used for physiologic assessment of skin barrier function. The TEWL measurements have also been combined with skin barrier perturbation using STS to measure skin barrier function and integrity. The ITT population included all enrolled participants, including participants who received at least 1 dose of study drug and healthy participants who had at least 1 TEWL/STS assessment performed, irrespective of compliance with the study protocol and procedures.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Week 16
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| 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 participants with atopic dermatitis were analyzed for the secondary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent adverse events (TEAEs) data was collected from the first administration of the study drug (Day 1) up to 14 days after last administration of the study drug (maximum exposure duration: up to 16 weeks).
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Adverse event reporting additional description |
Safety population included all enrolled participants, who actually received at least 1 dose of study drug or had at least 1 TEWL/STS assessment and all healthy participants who had at least 1 TEWL/STS assessment performed. TEAEs are not applicable for healthy participants because no study drug were taken.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Healthy Participants
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Reporting group description |
Participants didn't receive any treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Atopic Dermatitis Participants
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Reporting group description |
Participants aged >=12 to <18 years and body weight of <60 kg received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. Participants aged >=12 to <18 years and body weight of >=60 kg received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. Participants aged >=18 years received dupilumab first dose on Day 1, followed by dupilumab second dose Q2W for 16 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
