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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1244-1409 | Other Identifier | UTN | |
| 2020-000314-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis (AD) treated with dupilumab.
Secondary Objectives:
The duration for each participant was a total of approximately 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | No Intervention | 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 like enrolled AD participants. | |
| Atopic Dermatitis Patients | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab SAR231893 | Drug | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16 | 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. |
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Inclusion criteria :
- Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.
Atopic dermatitis participants:
Healthy volunteers:
Exclusion criteria:
Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (i.e., skin atrophy, ichthyosis, Netherton syndrome, severe photo damage).
Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that was adequate for TEWL assessments.
Hypersensitivity to the active substance or to any of the excipients of dupilumab.
Ocular disorder that in the opinion of the investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca or dry eye syndrome that required daily use of supplemental lubrication; or individuals with ocular conditions that required the use of ocular corticosteroids or cyclosporine.
Systemic AD treatment or phototherapy within 4 weeks of Baseline.
Topical AD treatment within 1 week of Baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator.
Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study. Examples included, but were not limited to participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c >=9%), participants with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, participants on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions) or lymphatic diseases. The specific justification for participants excluded under this criterion were noted in study documents (chart notes, electronic case report forms, screening logs, etc.).
History of hypersensitivity reaction to tape or adhesives.
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever was longer.
Current participation in another investigational clinical study.
Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who were legally institutionalized.
Participants were dependent on the Sponsor or Investigator (in conjunction with section 1.61 of the ICH-GCP Ordinance E6).
Individuals directly involved in the conduct of the study, or immediate family members of such individuals.
Any specific situation during study implementation/course that might rise ethics considerations.
Planned or anticipated major surgical procedure during the participant's participation in this study.
Pregnant or breast feeding women, or were planning to become pregnant or breastfeed during the participant's participation in this study.
Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control was defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 weeks after last dose of study drug. These included condom, spermicide, hormonal contraceptives, intrauterine device, or double barrier contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Additional requirements for acceptable contraception might apply in certain countries, based on local regulations. Investigators in these countries were notified accordingly in a protocol clarification letter.
*For females, menopause was defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of >=25 milliunits per milliliter must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions were not required to use additional contraception.
Healthy volunteers with a personal history of an atopic condition.
Healthy volunteers with use of any topical treatment anywhere except Cetaphil or Vanicream moisturizer on non-targeted skin areas.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400001 | Denver | Colorado | 80206 | United States | ||
| Investigational Site Number 1240001 |
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| Label | URL |
|---|---|
| LPS15991 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
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Healthy volunteer's cohort received no treatment and was considered as a reference comparator group.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on safety population: all enrolled participants who actually received at least one dose of investigational medicinal product (IMP) or had at least one transepidermal water loss (TEWL)/skin tape stripping (STS) assessment and all healthy volunteers who had at least one TEWL/STS assessment performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Atopic Dermatitis Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental Restoration Failure | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2020 | Jun 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2021 | Jun 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| Baseline, Week 16 |
| Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16 | 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. | Baseline, Week 16 |
| Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | Baseline, Week 16 |
| 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 | 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. | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| 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 | 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. | Baseline, Day 15, 29, 57, 85 and Week 16 |
| Montreal |
| H2X 2V1 |
| Canada |
| Lost to Follow-up |
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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). |
| BG002 | Total Title |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 16 |
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| Secondary | Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Week 16 |
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
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|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16 |
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|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | grams per square meter per hour | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 15, 29, 57, 85 and Week 16 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | nsts*g/m^2/hour | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
|
| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
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| Secondary | 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 | 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. | 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. | Posted | Mean | Standard Deviation | nsts*g/m^2/hour | Baseline, Day 15, 29, 57, 85 and Week 16 |
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 13 |
| 26 |
| EG001 | 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). | 0 | 26 | 0 | 26 | 20 | 26 |
| Foreign Body In Eye | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
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| Limb Injury | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
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| Blood Pressure Abnormal | Investigations | MedDRA24.0 | Systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA24.0 | Systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA24.0 | Systematic Assessment |
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| Noninfective Conjunctivitis | Eye disorders | MedDRA24.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
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| Food Poisoning | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Skin Burning Sensation | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
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| Abscess Limb | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA24.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA24.0 | Systematic Assessment |
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| Food Allergy | Immune system disorders | MedDRA24.0 | Systematic Assessment |
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| Injection Site Reaction | General disorders | MedDRA24.0 | Systematic Assessment |
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| Medical Device Site Erythema | General disorders | MedDRA24.0 | Systematic Assessment |
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| Medical Device Site Haemorrhage | General disorders | MedDRA24.0 | Systematic Assessment |
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| Medical Device Site Pain | General disorders | MedDRA24.0 | Systematic Assessment |
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| Medical Device Site Urticaria | General disorders | MedDRA24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA24.0 | Systematic Assessment |
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| Breast Tenderness | Reproductive system and breast disorders | MedDRA24.0 | Systematic Assessment |
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The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Lesional skin: Day 11 |
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| Lesional skin: Day 15 |
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| Lesional skin: Day 22 |
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| Lesional skin: Day 29 |
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| Lesional skin: Day 43 |
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| Lesional skin: Day 57 |
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| Lesional skin: Day 85 |
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| Lesional skin: Week 16 |
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| Non-Lesional skin: Day 4 |
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| Non-Lesional skin: Day 8 |
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| Non-Lesional skin: Day 11 |
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| Non-Lesional skin: Day 15 |
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| Non-Lesional skin: Day 22 |
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| Non-Lesional skin: Day 29 |
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| Non-Lesional skin: Day 43 |
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| Non-Lesional skin: Day 57 |
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| Non-Lesional skin: Day 85 |
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| Non-Lesional skin: Week 16 |
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| Lesional skin: Day 11 |
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| Lesional skin: Day 15 |
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| Lesional skin: Day 22 |
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| Lesional skin: Day 29 |
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| Lesional skin: Day 43 |
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| Lesional skin: Day 57 |
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| Lesional skin: Day 85 |
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| Lesional skin: Week 16 |
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| Non-Lesional skin: Day 4 |
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| Non-Lesional skin: Day 8 |
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| Non-Lesional skin: Day 11 |
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| Non-Lesional skin: Day 15 |
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| Non-Lesional skin: Day 22 |
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| Non-Lesional skin: Day 29 |
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| Non-Lesional skin: Day 43 |
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| Non-Lesional skin: Day 57 |
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| Non-Lesional skin: Day 85 |
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| Non-Lesional skin: Week 16 |
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| Day 11 |
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| Day 15 |
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| Day 22 |
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| Day 29 |
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| Day 43 |
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| Day 57 |
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| Day 85 |
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| Week 16 |
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| Day 11 |
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| Day 15 |
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| Day 22 |
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| Day 29 |
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| Day 43 |
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| Day 57 |
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| Day 85 |
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| Week 16 |
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| Lesional skin: After 5 STS: Day 57 |
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| Lesional skin: After 5 STS: Day 85 |
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| Lesional skin: After 5 STS: Week 16 |
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| Lesional skin: After 10 STS: Day 15 |
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| Lesional skin: After 10 STS: Day 29 |
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| Lesional skin: After 10 STS: Day 57 |
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| Lesional skin: After 10 STS: Day 85 |
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| Lesional skin: After 10 STS: Week 16 |
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| Lesional skin: After 15 STS: Day 15 |
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| Lesional skin: After 15 STS: Day 29 |
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| Lesional skin: After 15 STS: Day 57 |
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| Lesional skin: After 15 STS: Day 85 |
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| Lesional skin: After 15 STS: Week 16 |
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| Lesional skin: After 20 STS: Day 15 |
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| Lesional skin: After 20 STS: Day 29 |
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| Lesional skin: After 20 STS: Day 57 |
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| Lesional skin: After 20 STS: Day 85 |
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| Lesional skin: After 20 STS: Week 16 |
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| Non-Lesional skin: After 5 STS: Day 15 |
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| Non-Lesional skin: After 5 STS: Day 29 |
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| Non-Lesional skin: After 5 STS: Day 57 |
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| Non-Lesional skin: After 5 STS: Day 85 |
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| Non-Lesional skin: After 5 STS: Week 16 |
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| Non-Lesional skin: After 10 STS: Day 15 |
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| Non-Lesional skin: After 10 STS: Day 29 |
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| Non-Lesional skin: After 10 STS: Day 57 |
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| Non-Lesional skin: After 10 STS: Day 85 |
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| Non-Lesional skin: After 10 STS: Week 16 |
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| Non-Lesional skin: After 15 STS: Day 15 |
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| Non-Lesional skin: After 15 STS: Day 29 |
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| Non-Lesional skin: After 15 STS: Day 57 |
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| Non-Lesional skin: After 15 STS: Day 85 |
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| Non-Lesional skin: After 15 STS: Week 16 |
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| Non-Lesional skin: After 20 STS: Day 15 |
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| Non-Lesional skin: After 20 STS: Day 29 |
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| Non-Lesional skin: After 20 STS: Day 57 |
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| Non-Lesional skin: After 20 STS: Day 85 |
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| Non-Lesional skin: After 20 STS: Week 16 |
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| Lesional skin: After 5 STS: Day 57 |
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| Lesional skin: After 5 STS: Day 85 |
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| Lesional skin: After 5 STS: Week 16 |
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| Lesional skin: After 10 STS: Day 15 |
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| Lesional skin: After 10 STS: Day 29 |
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| Lesional skin: After 10 STS: Day 57 |
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| Lesional skin: After 10 STS: Day 85 |
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| Lesional skin: After 10 STS: Week 16 |
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| Lesional skin: After 15 STS: Day 15 |
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| Lesional skin: After 15 STS: Day 29 |
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| Lesional skin: After 15 STS: Day 57 |
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| Lesional skin: After 15 STS: Day 85 |
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| Lesional skin: After 15 STS: Week 16 |
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| Lesional skin: After 20 STS: Day 15 |
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| Lesional skin: After 20 STS: Day 29 |
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| Lesional skin: After 20 STS: Day 57 |
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| Lesional skin: After 20 STS: Day 85 |
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| Lesional skin: After 20 STS: Week 16 |
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| Non-Lesional skin: After 5 STS: Day 15 |
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| Non-Lesional skin: After 5 STS: Day 29 |
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| Non-Lesional skin: After 5 STS: Day 57 |
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| Non-Lesional skin: After 5 STS: Day 85 |
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| Non-Lesional skin: After 5 STS: Week 16 |
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| Non-Lesional skin: After 10 STS: Day 15 |
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| Non-Lesional skin: After 10 STS: Day 29 |
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| Non-Lesional skin: After 10 STS: Day 57 |
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| Non-Lesional skin: After 10 STS: Day 85 |
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| Non-Lesional skin: After 10 STS: Week 16 |
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| Non-Lesional skin: After 15 STS: Day 15 |
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| Non-Lesional skin: After 15 STS: Day 29 |
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| Non-Lesional skin: After 15 STS: Day 57 |
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| Non-Lesional skin: After 15 STS: Day 85 |
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| Non-Lesional skin: After 15 STS: Week 16 |
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| Non-Lesional skin: After 20 STS: Day 15 |
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| Non-Lesional skin: After 20 STS: Day 29 |
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| Non-Lesional skin: After 20 STS: Day 57 |
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| Non-Lesional skin: After 20 STS: Day 85 |
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| Non-Lesional skin: After 20 STS: Week 16 |
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| After 5 STS: Day 57 |
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| After 5 STS: Day 85 |
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| After 5 STS: Week 16 |
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| After 10 STS: Day 15 |
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| After 10 STS: Day 29 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 85 |
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| After 10 STS: Week 16 |
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| After 15 STS: Day 15 |
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| After 15 STS: Day 29 |
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| After 15 STS: Day 57 |
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| After 15 STS: Day 85 |
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| After 15 STS: Week 16 |
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| After 20 STS: Day 15 |
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| After 20 STS: Day 29 |
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| After 20 STS: Day 57 |
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| After 20 STS: Day 85 |
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| After 20 STS: Week 16 |
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| After 5 STS: Day 57 |
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| After 5 STS: Day 85 |
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| After 5 STS: Week 16 |
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| After 10 STS: Day 15 |
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| After 10 STS: Day 29 |
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| After 10 STS: Day 57 |
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| After 10 STS: Day 85 |
|
|
| After 10 STS: Week 16 |
|
|
| After 15 STS: Day 15 |
|
|
| After 15 STS: Day 29 |
|
|
| After 15 STS: Day 57 |
|
|
| After 15 STS: Day 85 |
|
|
| After 15 STS: Week 16 |
|
|
| After 20 STS: Day 15 |
|
|
| After 20 STS: Day 29 |
|
|
| After 20 STS: Day 57 |
|
|
| After 20 STS: Day 85 |
|
|
| After 20 STS: Week 16 |
|
|
|
| Lesional skin: Day 57 |
|
|
| Lesional skin: Day 85 |
|
|
| Lesional skin: Week 16 |
|
|
| Non-Lesional skin: Day 15 |
|
|
| Non-Lesional skin: Day 29 |
|
|
| Non-Lesional skin: Day 57 |
|
|
| Non-Lesional skin: Day 85 |
|
|
| Non-Lesional skin: Week 16 |
|
|
|
| Lesional skin: Day 57 |
|
|
| Lesional skin: Day 85 |
|
|
| Lesional skin: Week 16 |
|
|
| Non-Lesional skin: Day 15 |
|
|
| Non-Lesional skin: Day 29 |
|
|
| Non-Lesional skin: Day 57 |
|
|
| Non-Lesional skin: Day 85 |
|
|
| Non-Lesional skin: Week 16 |
|
|
| Title | Measurements |
|---|---|
|
| Day 85 |
|
| Week 16 |
|
| Title | Measurements |
|---|---|
|
| Day 85 |
|
| Week 16 |
|