Trial Outcomes & Findings for Dupilumab Skin Barrier Function Study in Atopic Dermatitis (NCT NCT04447417)

NCT ID: NCT04447417

Last Updated: 2025-09-18

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 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 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). Here, overall number of participants analyzed=participants evaluable for this OM.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline, Week 16
• Results posted on: 2025-09-18

Participant Flow

Study was conducted at 2 centers in the United States and Canada. A total of 52 eligible participants were enrolled between 16 July 2020 and 19 January 2021 under the AD participants cohort or the healthy volunteers cohort.

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

Participant milestones

Measure	Healthy Volunteer Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as AD participants.	Atopic Dermatitis Patients Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Overall Study STARTED	26	26
Overall Study COMPLETED	23	26
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Healthy Volunteer Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as AD participants.	Atopic Dermatitis Patients Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Overall Study Withdrawal by Subject	1	0
Overall Study Failure to meet inclusion criteria	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Baseline characteristics by cohort

Measure	Healthy Volunteer n=26 Participants Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as AD participants.	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).	Total Title n=52 Participants
Age, Continuous	33.4 years STANDARD_DEVIATION 16.4 • n=5 Participants	32.2 years STANDARD_DEVIATION 17.2 • n=7 Participants	32.8 years STANDARD_DEVIATION 16.7 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	42 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Modified intent-to-treat (mITT) population: all enrolled AD participants who received at least 1 dose of investigational medicinal product (IMP) and all enrolled healthy volunteers who had at least 1 TEWL/STS assessment performed, irrespective of compliance with protocol and procedures. If prohibited therapies used for AD, only visits prior to rescue treatment were considered. 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 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 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). Here, overall number of participants analyzed=participants evaluable for this OM.

Outcome measures

Measure

Atopic Dermatitis Patients n=21 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16

-54.6 percent change Standard Deviation 18.0

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16 Lesional skin	-47.7 percent change Standard Deviation 20.1
Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16 Non-Lesional skin	16.6 percent change Standard Deviation 91.5

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Lesional skin	-42.6 grams per square meter per hour Standard Deviation 22.1
Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Non-Lesional skin	-2.1 grams per square meter per hour Standard Deviation 26.2

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

-5.8 percent change Standard Deviation 46.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

-8.0 grams per square meter per hour Standard Deviation 19.2

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Lesional skin	-51.2 percent change Standard Deviation 17.4
Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Non-Lesional skin	25.1 percent change Standard Deviation 116.5

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 15 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Lesional skin	-43.1 grams per square meter per hour Standard Deviation 20.6
Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Non-Lesional skin	-2.0 grams per square meter per hour Standard Deviation 23.5

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

-7.2 percent change Standard Deviation 35.8

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

-4.5 grams per square meter per hour Standard Deviation 11.1

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Lesional skin	-54.9 percent change Standard Deviation 17.5
Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Non-Lesional skin	26.2 percent change Standard Deviation 111.8

SECONDARY outcome

Timeframe: Baseline, Week 16

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. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. Absolute change from Baseline at Week 16 in TEWL after 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Lesional skin	-41.2 grams per square meter per hour Standard Deviation 20.4
Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 Non-Lesional skin	-0.5 grams per square meter per hour Standard Deviation 17.9

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=22 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

-2.0 percent change Standard Deviation 23.5

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=22 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

-0.8 grams per square meter per hour Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 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 5 STS on LS (first spot) in AD participants were reported in this OM.

Outcome measures

Measure

Atopic Dermatitis Patients n=21 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16

-35.1 grams per square meter per hour Standard Deviation 17.1

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 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

Measure

Atopic Dermatitis Patients n=20 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

17.6 percent change Standard Deviation 82.2

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 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

Measure

Atopic Dermatitis Patients n=20 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

-0.8 grams per square meter per hour Standard Deviation 13.6

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

1.2 percent change Standard Deviation 21.9

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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 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

Measure

Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

0.0 grams per square meter per hour Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Population: Analyzed 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 and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Week 16	18.8 percent change Standard Deviation 85.2
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 4	-0.7 percent change Standard Deviation 30.1
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 8	-5.3 percent change Standard Deviation 42.1
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 11	-12.9 percent change Standard Deviation 32.6
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 15	-16.3 percent change Standard Deviation 34.5
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 22	-37.8 percent change Standard Deviation 20.6
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 29	-35.1 percent change Standard Deviation 19.9
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 43	-40.6 percent change Standard Deviation 21.4
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 57	-42.1 percent change Standard Deviation 20.9
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 85	-42.7 percent change Standard Deviation 23.8
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Week 16	-48.7 percent change Standard Deviation 22.6
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 4	25.2 percent change Standard Deviation 40.6
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 8	27.9 percent change Standard Deviation 59.5
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 11	20.1 percent change Standard Deviation 46.8
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 15	24.0 percent change Standard Deviation 56.1
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 22	14.5 percent change Standard Deviation 47.8
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 29	6.4 percent change Standard Deviation 47.0
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 43	5.6 percent change Standard Deviation 57.2
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 57	17.8 percent change Standard Deviation 85.4
Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 85	27.5 percent change Standard Deviation 99.1

SECONDARY outcome

Timeframe: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Population: Analyzed 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 and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 4	-3.0 grams per square meter per hour Standard Deviation 14.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 8	-5.6 grams per square meter per hour Standard Deviation 18.8
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 11	-8.2 grams per square meter per hour Standard Deviation 16.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 15	-10.4 grams per square meter per hour Standard Deviation 16.6
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 22	-19.3 grams per square meter per hour Standard Deviation 14.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 29	-17.7 grams per square meter per hour Standard Deviation 14.4
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 43	-20.9 grams per square meter per hour Standard Deviation 14.9
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 57	-20.9 grams per square meter per hour Standard Deviation 14.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Day 85	-22.4 grams per square meter per hour Standard Deviation 16.7
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Lesional skin: Week 16	-24.3 grams per square meter per hour Standard Deviation 16.3
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 4	2.7 grams per square meter per hour Standard Deviation 7.6
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 8	3.8 grams per square meter per hour Standard Deviation 11.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 11	2.1 grams per square meter per hour Standard Deviation 10.1
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 15	2.6 grams per square meter per hour Standard Deviation 11.5
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 22	0.4 grams per square meter per hour Standard Deviation 8.9
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 29	-1.2 grams per square meter per hour Standard Deviation 11.1
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 43	-1.7 grams per square meter per hour Standard Deviation 9.4
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 57	-0.9 grams per square meter per hour Standard Deviation 13.0
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Day 85	1.0 grams per square meter per hour Standard Deviation 15.3
Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Non-Lesional skin: Week 16	-0.7 grams per square meter per hour Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 Patients 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 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, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=24 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 4	42.6 percent change Standard Deviation 44.4
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 8	20.5 percent change Standard Deviation 38.4
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 11	15.9 percent change Standard Deviation 31.0
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 15	16.6 percent change Standard Deviation 25.1
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 22	18.5 percent change Standard Deviation 32.2
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 29	8.0 percent change Standard Deviation 20.2
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 43	4.0 percent change Standard Deviation 26.2
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 57	20.3 percent change Standard Deviation 31.9
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 85	6.0 percent change Standard Deviation 21.8
Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Week 16	4.3 percent change Standard Deviation 25.3

SECONDARY outcome

Timeframe: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 Patients 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 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, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=24 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 4	3.9 grams per square meter per hour Standard Deviation 4.6
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 8	1.4 grams per square meter per hour Standard Deviation 3.1
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 11	1.2 grams per square meter per hour Standard Deviation 3.3
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 15	1.5 grams per square meter per hour Standard Deviation 2.7
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 22	1.4 grams per square meter per hour Standard Deviation 2.5
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 29	0.4 grams per square meter per hour Standard Deviation 2.2
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 43	-0.1 grams per square meter per hour Standard Deviation 2.7
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 57	1.6 grams per square meter per hour Standard Deviation 4.0
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Day 85	0.1 grams per square meter per hour Standard Deviation 2.7
Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 Week 16	0.4 grams per square meter per hour Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed 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. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 15	-25.1 percent change Standard Deviation 34.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 29	-38.9 percent change Standard Deviation 23.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 57	-45.6 percent change Standard Deviation 23.5
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 85	-50.6 percent change Standard Deviation 26.7
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Week 16	-54.6 percent change Standard Deviation 18.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 15	-18.5 percent change Standard Deviation 30.7
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 29	-32.5 percent change Standard Deviation 29.1
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 57	-46.7 percent change Standard Deviation 22.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 85	-47.0 percent change Standard Deviation 25.6
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Week 16	-54.9 percent change Standard Deviation 17.5
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 15	-14.5 percent change Standard Deviation 24.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 29	-33.0 percent change Standard Deviation 17.7
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 57	-39.1 percent change Standard Deviation 22.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 85	-43.4 percent change Standard Deviation 24.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Week 16	-51.2 percent change Standard Deviation 17.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 15	-11.6 percent change Standard Deviation 27.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 29	-29.1 percent change Standard Deviation 18.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 57	-37.4 percent change Standard Deviation 22.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 85	-38.8 percent change Standard Deviation 28.2
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Week 16	-47.7 percent change Standard Deviation 20.1
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 15	49.8 percent change Standard Deviation 100.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 29	8.0 percent change Standard Deviation 46.1
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 57	22.8 percent change Standard Deviation 89.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 85	33.7 percent change Standard Deviation 106.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Week 16	17.6 percent change Standard Deviation 82.2
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 15	55.1 percent change Standard Deviation 109.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 29	4.5 percent change Standard Deviation 52.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 57	18.6 percent change Standard Deviation 91.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 85	31.0 percent change Standard Deviation 116.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Week 16	26.2 percent change Standard Deviation 111.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 15	70.9 percent change Standard Deviation 128.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 29	2.4 percent change Standard Deviation 58.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 57	23.5 percent change Standard Deviation 104.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 85	34.7 percent change Standard Deviation 112.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Week 16	25.1 percent change Standard Deviation 116.5
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 15	53.1 percent change Standard Deviation 96.0
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 29	-3.8 percent change Standard Deviation 53.2
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 57	14.3 percent change Standard Deviation 80.7
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 85	30.4 percent change Standard Deviation 104.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Week 16	16.6 percent change Standard Deviation 91.5

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed 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. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 15	-19.4 grams per square meter per hour Standard Deviation 21.8
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 29	-27.1 grams per square meter per hour Standard Deviation 20.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 57	-29.4 grams per square meter per hour Standard Deviation 19.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Day 85	-34.8 grams per square meter per hour Standard Deviation 21.6
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 5 STS: Week 16	-35.1 grams per square meter per hour Standard Deviation 17.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 15	-17.7 grams per square meter per hour Standard Deviation 24.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 29	-28.3 grams per square meter per hour Standard Deviation 25.9
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 57	-35.6 grams per square meter per hour Standard Deviation 23.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Day 85	-36.2 grams per square meter per hour Standard Deviation 21.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 10 STS: Week 16	-41.2 grams per square meter per hour Standard Deviation 20.4
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 15	-13.3 grams per square meter per hour Standard Deviation 23.9
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 29	-27.0 grams per square meter per hour Standard Deviation 16.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 57	-31.4 grams per square meter per hour Standard Deviation 22.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Day 85	-33.7 grams per square meter per hour Standard Deviation 18.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 15 STS: Week 16	-43.1 grams per square meter per hour Standard Deviation 20.6
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 15	-13.6 grams per square meter per hour Standard Deviation 26.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 29	-25.5 grams per square meter per hour Standard Deviation 16.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 57	-33.3 grams per square meter per hour Standard Deviation 23.4
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Day 85	-32.2 grams per square meter per hour Standard Deviation 22.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: After 20 STS: Week 16	-42.6 grams per square meter per hour Standard Deviation 22.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 15	8.2 grams per square meter per hour Standard Deviation 22.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 29	-1.0 grams per square meter per hour Standard Deviation 10.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 57	0.2 grams per square meter per hour Standard Deviation 14.8
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Day 85	3.4 grams per square meter per hour Standard Deviation 18.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 5 STS: Week 16	-0.8 grams per square meter per hour Standard Deviation 13.6
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 15	10.6 grams per square meter per hour Standard Deviation 29.0
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 29	-2.6 grams per square meter per hour Standard Deviation 14.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 57	-1.8 grams per square meter per hour Standard Deviation 18.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Day 85	2.4 grams per square meter per hour Standard Deviation 24.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 10 STS: Week 16	-0.5 grams per square meter per hour Standard Deviation 17.9
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 15	17.7 grams per square meter per hour Standard Deviation 37.6
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 29	-4.8 grams per square meter per hour Standard Deviation 20.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 57	-1.2 grams per square meter per hour Standard Deviation 25.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Day 85	3.8 grams per square meter per hour Standard Deviation 31.0
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 15 STS: Week 16	-2.0 grams per square meter per hour Standard Deviation 23.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 15	18.6 grams per square meter per hour Standard Deviation 37.7
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 29	-7.5 grams per square meter per hour Standard Deviation 25.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 57	-0.8 grams per square meter per hour Standard Deviation 27.7
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Day 85	5.5 grams per square meter per hour Standard Deviation 38.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: After 20 STS: Week 16	-2.1 grams per square meter per hour Standard Deviation 26.2

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 Patients 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 29	5.2 percent change Standard Deviation 24.5
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 15	15.9 percent change Standard Deviation 27.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 57	16.0 percent change Standard Deviation 27.6
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 85	5.8 percent change Standard Deviation 26.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Week 16	1.2 percent change Standard Deviation 21.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 15	17.6 percent change Standard Deviation 31.3
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 29	6.8 percent change Standard Deviation 27.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 57	13.7 percent change Standard Deviation 25.9
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 85	3.1 percent change Standard Deviation 26.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Week 16	-2.0 percent change Standard Deviation 23.5
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 15	32.3 percent change Standard Deviation 80.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 29	1.6 percent change Standard Deviation 37.1
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 57	15.3 percent change Standard Deviation 49.1
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 85	1.7 percent change Standard Deviation 60.2
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Week 16	-7.2 percent change Standard Deviation 35.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 15	44.2 percent change Standard Deviation 107.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 29	31.1 percent change Standard Deviation 94.8
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 57	22.0 percent change Standard Deviation 63.2
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 85	8.5 percent change Standard Deviation 89.4
Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Week 16	-5.8 percent change Standard Deviation 46.0

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable 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 Patients 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, 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 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 was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 15	1.7 grams per square meter per hour Standard Deviation 3.8
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 29	0.2 grams per square meter per hour Standard Deviation 2.9
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 57	1.6 grams per square meter per hour Standard Deviation 4.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Day 85	0.1 grams per square meter per hour Standard Deviation 3.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 5 STS: Week 16	0.0 grams per square meter per hour Standard Deviation 2.7
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 15	2.1 grams per square meter per hour Standard Deviation 5.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 29	0.4 grams per square meter per hour Standard Deviation 4.0
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 57	1.5 grams per square meter per hour Standard Deviation 5.4
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Day 85	-0.4 grams per square meter per hour Standard Deviation 4.2
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 10 STS: Week 16	-0.8 grams per square meter per hour Standard Deviation 4.0
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 15	3.3 grams per square meter per hour Standard Deviation 15.0
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 29	-1.9 grams per square meter per hour Standard Deviation 8.8
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 57	0.5 grams per square meter per hour Standard Deviation 12.8
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Day 85	-3.0 grams per square meter per hour Standard Deviation 12.7
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 15 STS: Week 16	-4.5 grams per square meter per hour Standard Deviation 11.1
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 15	5.6 grams per square meter per hour Standard Deviation 22.4
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 29	1.9 grams per square meter per hour Standard Deviation 20.5
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 57	0.0 grams per square meter per hour Standard Deviation 19.7
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Day 85	-5.2 grams per square meter per hour Standard Deviation 23.3
Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 After 20 STS: Week 16	-8.0 grams per square meter per hour Standard Deviation 19.2

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed 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. 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 and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Percent change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 29	1.0 percent change Standard Deviation 48.8
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 57	17.7 percent change Standard Deviation 89.4
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 85	29.5 percent change Standard Deviation 105.6
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 15	-17.0 percent change Standard Deviation 37.5
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 29	-20.5 percent change Standard Deviation 39.3
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 57	-24.3 percent change Standard Deviation 49.2
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 85	-24.5 percent change Standard Deviation 56.9
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Week 16	-29.2 percent change Standard Deviation 43.5
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 15	52.4 percent change Standard Deviation 99.9
Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Week 16	19.4 percent change Standard Deviation 97.6

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed 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, used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). 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. 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM. Expanded unit of measure is number of skin tape stripping*grams per square meter per hour.

Outcome measures

Measure	Atopic Dermatitis Patients n=26 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 15	-229.6 nsts*g/m^2/hour Standard Deviation 400.8
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 15	230.9 nsts*g/m^2/hour Standard Deviation 536.0
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 29	-66.2 nsts*g/m^2/hour Standard Deviation 299.3
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Week 16	-27.7 nsts*g/m^2/hour Standard Deviation 348.1
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 29	-278.0 nsts*g/m^2/hour Standard Deviation 384.1
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 57	-292.3 nsts*g/m^2/hour Standard Deviation 409.2
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Day 85	-284.8 nsts*g/m^2/hour Standard Deviation 448.7
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Lesional skin: Week 16	-321.2 nsts*g/m^2/hour Standard Deviation 464.2
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 57	-22.4 nsts*g/m^2/hour Standard Deviation 380.9
Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16 Non-Lesional skin: Day 85	59.1 nsts*g/m^2/hour Standard Deviation 483.9

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Percent Change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM.

Outcome measures

Measure	Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Week 16	-5.5 percent change Standard Deviation 30.5
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 15	23.3 percent change Standard Deviation 51.2
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 29	2.6 percent change Standard Deviation 39.6
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 57	14.0 percent change Standard Deviation 36.2
Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 85	1.0 percent change Standard Deviation 45.6

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 85 and Week 16

Population: Analyzed on mITT population. Here, overall number of participants analyzed = participants evaluable for this OM. Data for this OM was not planned to be collected and analyzed for Atopic Dermatitis Patients 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. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots 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 rule. Absolute change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM. Expanded unit of measure is number of skin tape stripping*grams per square meter per hour.

Outcome measures

Measure	Atopic Dermatitis Patients n=23 Participants Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 15	49.6 nsts*g/m^2/hour Standard Deviation 157.9
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 29	-17.7 nsts*g/m^2/hour Standard Deviation 133.2
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 57	20.9 nsts*g/m^2/hour Standard Deviation 145.2
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Day 85	-31.2 nsts*g/m^2/hour Standard Deviation 148.4
Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16 Week 16	-46.5 nsts*g/m^2/hour Standard Deviation 125.5

Adverse Events

Healthy Volunteer

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Atopic Dermatitis Patients

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Volunteer n=26 participants at risk Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as AD participants.	Atopic Dermatitis Patients n=26 participants at risk Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).
Injury, poisoning and procedural complications Dental Restoration Failure	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Injury, poisoning and procedural complications Foreign Body In Eye	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Injury, poisoning and procedural complications Limb Injury	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Investigations Blood Pressure Abnormal	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Eye disorders Conjunctivitis Allergic	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Eye disorders Dry Eye	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Eye disorders Noninfective Conjunctivitis	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Gastrointestinal disorders Abdominal Pain	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Gastrointestinal disorders Food Poisoning	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Gastrointestinal disorders Nausea	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Dermatitis	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Ecchymosis	11.5% 3/26 • Number of events 3 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Petechiae	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Skin Burning Sensation	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	11.5% 3/26 • Number of events 3 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Back Pain	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Pain In Extremity	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Abscess Limb	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Covid-19	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Herpes Zoster	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Hordeolum	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Tooth Abscess	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Vascular disorders Hypertension	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Immune system disorders Food Allergy	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
General disorders Injection Site Reaction	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	19.2% 5/26 • Number of events 6 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
General disorders Medical Device Site Erythema	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
General disorders Medical Device Site Haemorrhage	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	7.7% 2/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
General disorders Medical Device Site Pain	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
General disorders Medical Device Site Urticaria	3.8% 1/26 • Number of events 2 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Psychiatric disorders Anxiety	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Psychiatric disorders Insomnia	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.
Reproductive system and breast disorders Breast Tenderness	0.00% 0/26 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.	3.8% 1/26 • Number of events 1 • For AD participants: from first dose (i.e., Day 1) of IMP administration up to end of treatment visit (i.e., Day 113). For healthy volunteers: from signature of consent form to end of study (i.e., from screening to Day 141). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs) that occurred, worsened or became serious during TEAE period of AD participants (defined as time from 1st IMP administration to end of treatment) and for healthy volunteers: from signature of consent form to end of study. Analysis was performed on safety population.

Additional Information

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