Trial Outcomes & Findings for Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis (NCT NCT04718870)

Results Overview

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2025-09-15

Participant Flow

Study was conducted at 3 active sites in the United States and United Kingdom. A total of 43 participants were screened between 19 Feb 2021 and 12 May 2022, out of which 41 were enrolled and 2 were screen failures due to not meeting inclusion criteria.

Healthy volunteer's cohort received no treatment and was considered as a reference comparator group.

Participant milestones

Participant milestones
Measure	Healthy Volunteers Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected atopic dermatitis (AD) participants, received no treatment, but were monitored in a similar way as AD participants.	Atopic Dermatitis Participants Pediatric participants with moderate-to-severe AD and with baseline body weight more than or equal to (\>=) 15 kilograms (kg) and less than (\<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14.
Overall Study STARTED	18	23
Overall Study COMPLETED	18	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=18 Participants Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to selected AD participants, received no treatment, but were monitored in a similar way as AD participants.	Atopic Dermatitis Participants n=23 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.	Total n=41 Participants Total of all reporting groups
Age, Continuous	8.2 years STANDARD_DEVIATION 1.8 • n=5 Participants	7.8 years STANDARD_DEVIATION 1.6 • n=7 Participants	8.0 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for Healthy Volunteer arm as pre-specified in protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM).

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=18 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16	-38.5633 percent change Standard Deviation 27.1211

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16	-33.1336 percent change Standard Deviation 28.1613

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that was used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS (first spot) in AD participants were reported in this OM

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16	-35.6671 grams per square meter per hour Standard Deviation 31.2267

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16	-6.1452 percent change Standard Deviation 67.9496

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16	-13.6682 grams per square meter per hour Standard Deviation 33.3065

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16	13.2578 percent change Standard Deviation 64.3880

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16	5.9327 grams per square meter per hour Standard Deviation 32.0123

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=18 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16	-33.3119 percent change Standard Deviation 32.7125

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=18 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16	-33.4028 grams per square meter per hour Standard Deviation 31.1957

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16	-7.6067 percent change Standard Deviation 54.7945

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16	-12.6576 grams per square meter per hour Standard Deviation 30.0412

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participants arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16	4.5364 percent change Standard Deviation 42.7525

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16	0.1082 grams per square meter per hour Standard Deviation 17.5865

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16	-34.7741 percent change Standard Deviation 31.0541

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16	-33.1024 grams per square meter per hour Standard Deviation 36.2286

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16	-3.8193 percent change Standard Deviation 74.6263

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16	-10.9488 grams per square meter per hour Standard Deviation 31.1300

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16	0.7091 percent change Standard Deviation 25.0615

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis participant arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16	-1.3482 grams per square meter per hour Standard Deviation 6.6778

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16	-4.8842 percent change Standard Deviation 70.5670

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for healthy volunteer arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=17 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16	-9.0771 grams per square meter per hour Standard Deviation 21.3022

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16	1.4464 percent change Standard Deviation 26.7257

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM. Data for this OM was not planned to be collected and analyzed for atopic dermatitis arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=11 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16	-1.0255 grams per square meter per hour Standard Deviation 4.3657

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline ('predefined skin area'). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=23 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	-7.1596 percent change Standard Deviation 36.6637
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	-6.3439 percent change Standard Deviation 33.8145
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	-7.0747 percent change Standard Deviation 28.3554
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	-8.1780 percent change Standard Deviation 44.9382
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-30.3070 percent change Standard Deviation 33.6643
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	-29.1730 percent change Standard Deviation 31.7167
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-37.8349 percent change Standard Deviation 24.7709
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	-33.0139 percent change Standard Deviation 27.8560
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	-36.1625 percent change Standard Deviation 28.9829
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	-32.9996 percent change Standard Deviation 33.2028
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	-38.2449 percent change Standard Deviation 40.0558
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	-39.3104 percent change Standard Deviation 27.6888
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	-35.8992 percent change Standard Deviation 27.9526
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	-45.6060 percent change Standard Deviation 23.2839
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	-41.1371 percent change Standard Deviation 24.5842
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	-36.0863 percent change Standard Deviation 33.7259
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	-37.4815 percent change Standard Deviation 30.8507
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	-32.3491 percent change Standard Deviation 29.2966
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	-40.9536 percent change Standard Deviation 30.9966
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	-20.8463 percent change Standard Deviation 50.6518
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	-31.3185 percent change Standard Deviation 42.0614
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	-35.2305 percent change Standard Deviation 45.8818
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	-37.8675 percent change Standard Deviation 29.0275
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	-15.3096 percent change Standard Deviation 45.6163
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	-11.0740 percent change Standard Deviation 35.5483
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	-27.0015 percent change Standard Deviation 25.8528
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	-32.7080 percent change Standard Deviation 28.8445
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	-40.8609 percent change Standard Deviation 30.8002
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	-30.3358 percent change Standard Deviation 48.3028
Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	-36.5267 percent change Standard Deviation 37.7230

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on LS (at each spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=23 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	-9.3486 grams per square meter per hour Standard Deviation 21.2256
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	-15.4336 grams per square meter per hour Standard Deviation 25.0975
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	-9.8073 grams per square meter per hour Standard Deviation 19.7385
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	-7.6682 grams per square meter per hour Standard Deviation 21.9239
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-23.0157 grams per square meter per hour Standard Deviation 26.8847
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	-20.7186 grams per square meter per hour Standard Deviation 23.4149
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	-21.2010 grams per square meter per hour Standard Deviation 21.2593
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	-17.9170 grams per square meter per hour Standard Deviation 19.7310
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	-27.0535 grams per square meter per hour Standard Deviation 28.0249
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	-24.5188 grams per square meter per hour Standard Deviation 25.6684
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	-3.1965 grams per square meter per hour Standard Deviation 14.4640
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	-15.6557 grams per square meter per hour Standard Deviation 20.1212
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-23.9585 grams per square meter per hour Standard Deviation 21.7106
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	-20.7018 grams per square meter per hour Standard Deviation 22.5936
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	-25.1221 grams per square meter per hour Standard Deviation 27.0210
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	-24.2358 grams per square meter per hour Standard Deviation 24.6028
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	-6.0491 grams per square meter per hour Standard Deviation 17.5810
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	-27.4493 grams per square meter per hour Standard Deviation 33.7080
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	-22.5607 grams per square meter per hour Standard Deviation 31.7696
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	-22.0860 grams per square meter per hour Standard Deviation 27.1286
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	-20.3379 grams per square meter per hour Standard Deviation 20.3751
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	-29.1917 grams per square meter per hour Standard Deviation 24.3114
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	-24.4494 grams per square meter per hour Standard Deviation 24.2054
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	-23.1056 grams per square meter per hour Standard Deviation 20.4692
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	-24.6678 grams per square meter per hour Standard Deviation 27.8013
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	-23.2878 grams per square meter per hour Standard Deviation 26.5670
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	-17.9028 grams per square meter per hour Standard Deviation 22.2483
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	-28.2564 grams per square meter per hour Standard Deviation 29.2212
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	-18.7786 grams per square meter per hour Standard Deviation 31.4917
Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	-19.8921 grams per square meter per hour Standard Deviation 27.8520

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=23 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	41.0825 percent change Standard Deviation 91.3744
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	13.5236 percent change Standard Deviation 49.3733
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	9.7943 percent change Standard Deviation 43.9272
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	19.0612 percent change Standard Deviation 58.1703
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	9.6866 percent change Standard Deviation 52.6831
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	13.2574 percent change Standard Deviation 55.8095
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-3.9277 percent change Standard Deviation 35.9880
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	8.9306 percent change Standard Deviation 70.2617
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	0.4973 percent change Standard Deviation 49.5636
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-8.9585 percent change Standard Deviation 39.0443
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	-10.5728 percent change Standard Deviation 35.2672
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	-13.0407 percent change Standard Deviation 44.5264
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	-15.6919 percent change Standard Deviation 29.7995
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	-21.6885 percent change Standard Deviation 30.1255
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	-16.2025 percent change Standard Deviation 42.7984
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	-24.5008 percent change Standard Deviation 26.9801
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	-27.6040 percent change Standard Deviation 23.0969
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	-25.7321 percent change Standard Deviation 33.1310
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	-21.9316 percent change Standard Deviation 34.3620
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	-16.7008 percent change Standard Deviation 62.4384
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	-29.2721 percent change Standard Deviation 40.0673
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	-20.4359 percent change Standard Deviation 42.6948
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	-23.1303 percent change Standard Deviation 41.2717
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	-27.4981 percent change Standard Deviation 33.5326
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	-6.7535 percent change Standard Deviation 73.4261
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	-16.3903 percent change Standard Deviation 41.9864
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	-19.3970 percent change Standard Deviation 46.5302
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	-23.3812 percent change Standard Deviation 39.5978
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	-27.3104 percent change Standard Deviation 32.8267
Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	-22.1813 percent change Standard Deviation 40.5124

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Non-LS areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined non-LS areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on non-LS (at each spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=23 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	4.1752 grams per square meter per hour Standard Deviation 14.1047
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	-2.6176 grams per square meter per hour Standard Deviation 13.1001
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	-6.7411 grams per square meter per hour Standard Deviation 13.5999
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	-9.7772 grams per square meter per hour Standard Deviation 11.7879
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	-8.2272 grams per square meter per hour Standard Deviation 11.6158
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	-8.0665 grams per square meter per hour Standard Deviation 11.9970
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	-8.9200 grams per square meter per hour Standard Deviation 11.3266
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	-10.4414 grams per square meter per hour Standard Deviation 14.5146
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	-5.3314 grams per square meter per hour Standard Deviation 12.8392
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-5.3400 grams per square meter per hour Standard Deviation 10.8674
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	-9.5905 grams per square meter per hour Standard Deviation 14.0754
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	-6.7424 grams per square meter per hour Standard Deviation 9.7834
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	-8.8444 grams per square meter per hour Standard Deviation 12.4876
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	-0.0248 grams per square meter per hour Standard Deviation 11.8585
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	-0.3413 grams per square meter per hour Standard Deviation 9.8571
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	0.4723 grams per square meter per hour Standard Deviation 9.7975
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	-1.0171 grams per square meter per hour Standard Deviation 11.3877
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-3.8162 grams per square meter per hour Standard Deviation 10.3046
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	-3.5735 grams per square meter per hour Standard Deviation 16.4593
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	-10.5600 grams per square meter per hour Standard Deviation 14.1984
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	-8.2874 grams per square meter per hour Standard Deviation 8.5546
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	-11.9179 grams per square meter per hour Standard Deviation 13.1662
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	-7.6171 grams per square meter per hour Standard Deviation 16.1511
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	-13.1811 grams per square meter per hour Standard Deviation 14.4647
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	-9.2906 grams per square meter per hour Standard Deviation 13.7202
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	-11.2776 grams per square meter per hour Standard Deviation 12.9322
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	-7.0229 grams per square meter per hour Standard Deviation 15.4066
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	-7.0408 grams per square meter per hour Standard Deviation 12.8562
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	-11.2953 grams per square meter per hour Standard Deviation 15.3452
Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	-11.1625 grams per square meter per hour Standard Deviation 16.2087

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Percent change from Baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	5.0103 percent change Standard Deviation 39.4170
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	9.9969 percent change Standard Deviation 14.4219
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	8.4098 percent change Standard Deviation 15.2499
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	2.9668 percent change Standard Deviation 30.1272
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	3.3636 percent change Standard Deviation 26.9400
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	-8.7688 percent change Standard Deviation 20.5764
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	-3.8203 percent change Standard Deviation 19.5160
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	1.9837 percent change Standard Deviation 27.7012
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	-4.0758 percent change Standard Deviation 22.1886
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	-1.7489 percent change Standard Deviation 21.1652
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-2.6655 percent change Standard Deviation 19.8558
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	7.5939 percent change Standard Deviation 22.7859
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	3.8603 percent change Standard Deviation 12.1068
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-1.7648 percent change Standard Deviation 21.4820
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	1.4115 percent change Standard Deviation 27.8012
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	13.4093 percent change Standard Deviation 35.9985
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	7.6533 percent change Standard Deviation 24.0747
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	5.3384 percent change Standard Deviation 17.9065
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	12.6926 percent change Standard Deviation 24.7125
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	5.2021 percent change Standard Deviation 23.1397
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	0.7096 percent change Standard Deviation 19.5448
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	5.1021 percent change Standard Deviation 20.0690
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	2.6054 percent change Standard Deviation 26.2241
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	9.4234 percent change Standard Deviation 24.1533
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	17.0905 percent change Standard Deviation 16.4596
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	10.3105 percent change Standard Deviation 52.8138
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	11.2398 percent change Standard Deviation 22.7028
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	11.5842 percent change Standard Deviation 27.2298
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	5.3772 percent change Standard Deviation 19.9583
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	12.0900 percent change Standard Deviation 24.8690

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197

Population: Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed. Absolute change from baseline at specified time points in TEWL before STS on normal skin (at each spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 2	-1.8215 grams per square meter per hour Standard Deviation 3.3907
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 3	-0.3829 grams per square meter per hour Standard Deviation 3.3925
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 1	-0.7575 grams per square meter per hour Standard Deviation 3.2991
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 2	1.0233 grams per square meter per hour Standard Deviation 3.7207
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 1	-1.1631 grams per square meter per hour Standard Deviation 3.1429
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 2	0.8585 grams per square meter per hour Standard Deviation 1.8609
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 29 - Spot 3	0.7938 grams per square meter per hour Standard Deviation 1.7624
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 1	-1.0129 grams per square meter per hour Standard Deviation 4.0940
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 2	-0.8357 grams per square meter per hour Standard Deviation 4.7103
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 2	0.2283 grams per square meter per hour Standard Deviation 2.6839
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 1	-0.3791 grams per square meter per hour Standard Deviation 3.4231
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 2	0.4882 grams per square meter per hour Standard Deviation 2.5528
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 113 - Spot 3	2.0527 grams per square meter per hour Standard Deviation 2.1762
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 1	-0.9293 grams per square meter per hour Standard Deviation 6.5972
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 2	0.6880 grams per square meter per hour Standard Deviation 3.7653
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 155 - Spot 3	0.4793 grams per square meter per hour Standard Deviation 4.5057
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 1	-0.6153 grams per square meter per hour Standard Deviation 4.8187
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 2	-0.0427 grams per square meter per hour Standard Deviation 3.6560
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 1	-0.5786 grams per square meter per hour Standard Deviation 3.3947
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 15 - Spot 2	-1.0029 grams per square meter per hour Standard Deviation 3.4320
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 22 - Spot 3	0.6433 grams per square meter per hour Standard Deviation 2.0759
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 43 - Spot 3	0.7057 grams per square meter per hour Standard Deviation 5.1247
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 1	0.6308 grams per square meter per hour Standard Deviation 4.1304
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 1	-0.2508 grams per square meter per hour Standard Deviation 4.8798
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 8 - Spot 3	-0.7869 grams per square meter per hour Standard Deviation 2.9791
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 57 - Spot 3	1.5142 grams per square meter per hour Standard Deviation 4.1943
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 1	0.0164 grams per square meter per hour Standard Deviation 3.2348
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 2	-0.3221 grams per square meter per hour Standard Deviation 3.5460
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 85 - Spot 3	0.2779 grams per square meter per hour Standard Deviation 3.8491
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197 Day 197 - Spot 3	0.6747 grams per square meter per hour Standard Deviation 4.8536

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 57	-38.2091 percent change Standard Deviation 25.6654
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 113	-34.0025 percent change Standard Deviation 29.1866
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 197	-40.0143 percent change Standard Deviation 26.9737

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS (nsts) used to reflect the overall integrity of stratum corneum. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 57	-632.0224 nsts*grams per square meter per hour Standard Deviation 494.4981
Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 113	-608.1875 nsts*grams per square meter per hour Standard Deviation 601.7999
Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197 Day 197	-659.4033 nsts*grams per square meter per hour Standard Deviation 570.2425

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS reflect the overall integrity of the stratum corneum. Non-LS areas for TEWL assessment \& STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS \& after 5, 10, 15 \& 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before \& after 5, 10, 15 \&20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 \& 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 57	-21.7570 percent change Standard Deviation 29.1137
Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 113	-10.8940 percent change Standard Deviation 50.7679
Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 197	-28.6897 percent change Standard Deviation 26.0253

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Non-LS areas for TEWL assessment and STS were identified at baseline(predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10,15 and 20 STS on pre-defined non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline(Week 0, Day 1), Days 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL AUC (first spot) in AD participants reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 57	-281.9579 nsts*grams per square meter per hour Standard Deviation 342.1271
Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 113	-217.7544 nsts*grams per square meter per hour Standard Deviation 462.0173
Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197 Day 197	-367.5469 nsts*grams per square meter per hour Standard Deviation 340.1948

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over a defined number of STS used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment \& STS were identified at baseline(predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS \& after 5, 10,15 \& 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC: composite measure before \& after 5, 10, 15\& 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 \& 197 conducted on first spot. Percent Change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 57	3.2794 percent change Standard Deviation 15.6493
Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 113	3.4753 percent change Standard Deviation 30.2504
Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 197	-10.1582 percent change Standard Deviation 18.4753

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL: noninvasive in vivo measurement of water loss across stratum corneum to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS used to reflect the overall integrity of stratum corneum. Normal skin areas for TEWL assessment and STS identified at baseline(predefined skin area). Within predefined Normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL measured prior to STS and after 5, 10,15 and 20 STS on pre-defined Normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10,15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal method. STS assessment at baseline (Week 0, Day 1), Days 57, 113 and 197 conducted on first spot. Percent change from baseline at specified time points in TEWL AUC (first spot) in healthy volunteers reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 57	16.8563 nsts*grams per square meter per hour Standard Deviation 70.4582
Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 113	2.5568 nsts*grams per square meter per hour Standard Deviation 197.8379
Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 Day 197	-72.9050 nsts*grams per square meter per hour Standard Deviation 108.8230

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participant were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 57	-42.2019 percent change Standard Deviation 22.5314
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 113	-38.5633 percent change Standard Deviation 27.1211
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 197	-36.4601 percent change Standard Deviation 47.5902
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 57	-40.4595 percent change Standard Deviation 27.4572
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 113	-34.7741 percent change Standard Deviation 31.0541
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 197	-39.9440 percent change Standard Deviation 29.2084
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 57	-41.6561 percent change Standard Deviation 24.0960
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 113	-33.3119 percent change Standard Deviation 32.7125
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 197	-38.4286 percent change Standard Deviation 27.0978
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 57	-34.8297 percent change Standard Deviation 23.0520
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 113	-33.1336 percent change Standard Deviation 28.1613
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 197	-35.6561 percent change Standard Deviation 23.0987

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of skin are peeled away using adhesive discs. LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 57	-31.3795 grams per square meter per hour Standard Deviation 25.4943
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 113	-31.1761 grams per square meter per hour Standard Deviation 31.3420
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 197	-33.5753 grams per square meter per hour Standard Deviation 40.1857
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 57	-36.4267 grams per square meter per hour Standard Deviation 31.1758
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 113	-33.1024 grams per square meter per hour Standard Deviation 36.2286
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 197	-35.8254 grams per square meter per hour Standard Deviation 33.3362
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 57	-37.9779 grams per square meter per hour Standard Deviation 23.3049
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 113	-33.4028 grams per square meter per hour Standard Deviation 31.1957
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 197	-36.0843 grams per square meter per hour Standard Deviation 27.5612
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 57	-35.0726 grams per square meter per hour Standard Deviation 23.5765
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 113	-35.6671 grams per square meter per hour Standard Deviation 31.2267
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 197	-34.5257 grams per square meter per hour Standard Deviation 23.9001

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 57	-24.8218 percent change Standard Deviation 31.4633
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 113	-4.8842 percent change Standard Deviation 70.5670
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 197	-29.7635 percent change Standard Deviation 44.0691
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 57	-20.3640 percent change Standard Deviation 43.5318
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 113	-3.8193 percent change Standard Deviation 74.6263
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 197	-29.6888 percent change Standard Deviation 38.9536
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 57	-18.4348 percent change Standard Deviation 33.3647
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 113	-7.6067 percent change Standard Deviation 54.7945
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 197	-27.2268 percent change Standard Deviation 25.1580
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 57	-19.2584 percent change Standard Deviation 30.1343
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 113	-6.1452 percent change Standard Deviation 67.9496
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 197	-22.3311 percent change Standard Deviation 23.0908

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'healthy volunteer' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Non-LS areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined non-LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on the first spot. Absolute change from baseline at specified time points in TEWL after STS on non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=19 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 57	-11.8526 grams per square meter per hour Standard Deviation 12.6180
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 113	-9.0771 grams per square meter per hour Standard Deviation 21.3022
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 5 STS: Day 197	-15.8375 grams per square meter per hour Standard Deviation 18.0369
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 57	-15.0005 grams per square meter per hour Standard Deviation 20.1721
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 113	-10.9488 grams per square meter per hour Standard Deviation 31.1300
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 10 STS: Day 197	-21.2825 grams per square meter per hour Standard Deviation 23.2998
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 57	-16.1047 grams per square meter per hour Standard Deviation 26.4807
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 113	-12.6576 grams per square meter per hour Standard Deviation 30.0412
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 15 STS: Day 197	-21.9006 grams per square meter per hour Standard Deviation 19.2885
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 57	-18.5800 grams per square meter per hour Standard Deviation 30.3574
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 113	-13.6682 grams per square meter per hour Standard Deviation 33.3065
Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197 After 20 STS: Day 197	-20.0575 grams per square meter per hour Standard Deviation 16.1537

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 was conducted on first spot. Percent change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 57	4.9595 percent change Standard Deviation 16.0950
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 113	1.4464 percent change Standard Deviation 26.7257
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 197	-1.6729 percent change Standard Deviation 25.2293
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 57	4.0996 percent change Standard Deviation 20.4647
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 113	0.7091 percent change Standard Deviation 25.0615
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 197	-7.4475 percent change Standard Deviation 19.7215
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 57	3.2339 percent change Standard Deviation 20.9086
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 113	4.5364 percent change Standard Deviation 42.7525
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 197	-14.0103 percent change Standard Deviation 18.5552
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 57	4.3494 percent change Standard Deviation 27.5527
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 113	13.2578 percent change Standard Deviation 64.3880
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 197	-18.0480 percent change Standard Deviation 22.6193

SECONDARY outcome

Timeframe: Baseline, Days 57, 113 and 197

Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for 'atopic dermatitis participant' arm as pre-specified in the protocol.

TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at baseline (predefined skin area). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at baseline (Week 0, Day 1), Day 57, 113 and 197 were conducted on first spot. Absolute change from baseline at specified time points in TEWL after STS on normal skin (first spot) in healthy volunteers were reported in this OM.

Outcome measures

Outcome measures
Measure	Atopic Dermatitis Participants n=15 Participants Pediatric participants with moderate-to-severe AD and with baseline body weight \>=15 kg and \<30 kg received a SC loading dose of dupilumab 600 mg (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection Q4W, from Week 4 to Week 12. Pediatric participants with body weight \>=30 kg and \<60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection Q2W, from Week 2 to Week 14.
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 57	0.5642 grams per square meter per hour Standard Deviation 3.3355
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 113	-1.0255 grams per square meter per hour Standard Deviation 4.3657
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 57	3.4683 grams per square meter per hour Standard Deviation 9.8235
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 5 STS: Day 197	-1.5627 grams per square meter per hour Standard Deviation 5.2934
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 57	0.2825 grams per square meter per hour Standard Deviation 4.5142
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 113	-1.3482 grams per square meter per hour Standard Deviation 6.6778
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 10 STS: Day 197	-3.0880 grams per square meter per hour Standard Deviation 5.2754
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 57	0.4750 grams per square meter per hour Standard Deviation 6.4442
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 113	0.1082 grams per square meter per hour Standard Deviation 17.5865
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 15 STS: Day 197	-5.8847 grams per square meter per hour Standard Deviation 8.1968
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 113	5.9327 grams per square meter per hour Standard Deviation 32.0123
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197 After 20 STS: Day 197	-7.4760 grams per square meter per hour Standard Deviation 9.3514

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Atopic Dermatitis Participant

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Publication restrictions are in place

Restriction type: OTHER