Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, extrinsic atopic dermatitis, intrinsic atopic dermatitis
Brief summary
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families. In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.
Detailed description
This is a randomized, double-blind, pilot study of a total of 44 subjects with AD (22 with intrinsic and 22 with extrinsic AD) consisting of 2 phases. Subjects will be randomized (2:1) to either receive secukinumab 300 mg or placebo via subcutaneous injection using 2 prefilled syringes.
Interventions
DRUGSecukinumab
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
DRUGPlacebo
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
Sponsors
Novartis
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject at least 18 years of age * If female, the subject is not pregnant or nursing * Subject is able to provide written informed consent and comply with the requirements of this study protocol. * Chronic (\>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200). * Moderate to severe AD (SCORAD index ≥25, and IGA index≥3). * Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year. * Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis. * Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination. * Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Exclusion criteria
* Male or female subject at least 18 years of age * If female, the subject is not pregnant or nursing * Subject is able to provide written informed consent and comply with the requirements of this study protocol. * Chronic (\>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200). * Moderate to severe AD (SCORAD index ≥25, and IGA index≥3). * Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year. * Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis. * Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination. * Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold-Change in Epidermal Thickness of Lesional Skin | at Week 16 | Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With SCORAD-50 | Week 4, Week 16, Week 32, Week 52 | The proportion of patients who achieve an improvement of 50% or greater from their Baseline objective SCORAD up to week 52. SCORing Atopic Dermatitis (SCORAD) -The intensity part of the SCORAD index consists of six items: erythema, edema⁄papulation, excoriations, lichenification, oozing⁄crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms. |
| Number of Patients Who Achieve EASI-50 Score | Week 4, Week 16, Week 32, Week 52 | The proportion of patients who achieve an improvement of 50% or greater from their Baseline EASI score up to week 52. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity. |
| Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 16, Week 32, Week 52 | The proportion of patients who achieve a score of clear-0 or almost clear-1 in the static IGA score at Week 16 as compared to Baseline. The static IGA score represents an overall static evaluation of dermatitis, performed by the investigator at each visit. It utilizes a scale of 6-points; total scale ranging from 0 (clear) to 5 (very severe disease). |
| Percentage Change From Baseline in SCORAD Score | at Week 16 | Percentage change in SCORAD scores at Week 16 as compared to baseline. SCORing Atopic Dermatitis (SCORAD) full score is 0-103, with higher score indicating more symptoms. |
| Percentage Change From Baseline in EASI Scores | at Week 16 | Percentage change in EASI scores at Week 16 as compared to baseline. Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity. |
| Fold-Change in Elafin/Pi3 Level From Baseline | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of elafin/Pi3 at week 16 as compared to baseline |
| Fold-Change in K16 Expression of Lesional Skin | at Week 16 | Epidermal hyperplasia assessed using change in the epidermal proliferation marker Ki67 at week 16 as compared to baseline. Staining quantification was performed with ImageJ 1.42 |
| Fold-Change in CXCL1 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CXCL1 at week 16 as compared to baseline. |
| Fold-Change in S100A7 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of S100A7 at week 16 as compared to baseline. |
| Fold-Change in A8 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A8 at week 16 as compared to baseline |
| Fold-Change in A9 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A9 at Week 16 as compared to baseline. |
| Fold-Change in A12 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline |
| Fold-Change in CCL20 Level | at Week 16 | Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CCL20 at week 16 as compared to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then Secukinumab Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule. | 14 |
| Secukinumab Only Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48. | 27 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 17 | 6 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Seek alternative treatment | 2 | 1 |
| Overall Study | Terminated participation | 6 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Secukinumab Only | Placebo Then Secukinumab |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 14.5 | 38.3 years STANDARD_DEVIATION 13.8 | 33.9 years STANDARD_DEVIATION 15.9 |
| Eczema Area and Severity Index (EASI) score | 29.3 units on a scale STANDARD_DEVIATION 12.04 | 29.0 units on a scale STANDARD_DEVIATION 12 | 29.9 units on a scale STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 24 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| IgE level | 4555.8 kU/L STANDARD_DEVIATION 9348.9 | 5101 kU/L STANDARD_DEVIATION 11157 | 3424 kU/L STANDARD_DEVIATION 3509 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 14 Participants | 6 Participants |
| SCORing Atopic Dermatitis (SCORAD) score | 64.4 units on a scale STANDARD_DEVIATION 13 | 65.0 units on a scale STANDARD_DEVIATION 12.7 | 63.3 units on a scale STANDARD_DEVIATION 14.1 |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 23 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 27 |
| other Total, other adverse events | 0 / 14 | 3 / 27 |
| serious Total, serious adverse events | 0 / 14 | 0 / 27 |
Outcome results
Primary
Fold-Change in Epidermal Thickness of Lesional Skin
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Time frame: at Week 16
Population: Data only for those that returned for week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in Epidermal Thickness of Lesional Skin | 1.15 fold-change | Standard Error 1.22 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in Epidermal Thickness of Lesional Skin | 1.5 fold-change | Standard Error 1.3 |
| Secukinumab Only for Extrinsic AD | Fold-Change in Epidermal Thickness of Lesional Skin | 1.18 fold-change | Standard Error 1.15 |
| Secukinumab Only for Intrinsic AD | Fold-Change in Epidermal Thickness of Lesional Skin | -1 fold-change | Standard Error 1.15 |
Secondary
Fold-Change in A12 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline
Time frame: at Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in A12 Level | 1.24 fold-change | Standard Error 2.24 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in A12 Level | -15.06 fold-change | Standard Error 2.91 |
| Secukinumab Only for Extrinsic AD | Fold-Change in A12 Level | 1.95 fold-change | Standard Error 1.76 |
| Secukinumab Only for Intrinsic AD | Fold-Change in A12 Level | -2.87 fold-change | Standard Error 2.17 |
Secondary
Fold-Change in A8 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A8 at week 16 as compared to baseline
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in A8 Level | -1.32 fold-change | Standard Error 2.12 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in A8 Level | -9.51 fold-change | Standard Error 2.72 |
| Secukinumab Only for Extrinsic AD | Fold-Change in A8 Level | 1.51 fold-change | Standard Error 1.69 |
| Secukinumab Only for Intrinsic AD | Fold-Change in A8 Level | -2.61 fold-change | Standard Error 2.1 |
Secondary
Fold-Change in A9 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A9 at Week 16 as compared to baseline.
Time frame: at Week 16
Population: data only for those who returned for week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in A9 Level | -1.47 fold-change | Standard Error 0.86 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in A9 Level | -20.03 fold-change | Standard Error 1.36 |
| Secukinumab Only for Extrinsic AD | Fold-Change in A9 Level | 1.58 fold-change | Standard Error 0.6 |
| Secukinumab Only for Intrinsic AD | Fold-Change in A9 Level | -2.16 fold-change | Standard Error 0.85 |
Secondary
Fold-Change in CCL20 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CCL20 at week 16 as compared to baseline.
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in CCL20 Level | 1.35 fold-change | Standard Error 1.76 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in CCL20 Level | -1.38 fold-change | Standard Error 2.1 |
| Secukinumab Only for Extrinsic AD | Fold-Change in CCL20 Level | 1.23 fold-change | Standard Error 1.48 |
| Secukinumab Only for Intrinsic AD | Fold-Change in CCL20 Level | -1.85 fold-change | Standard Error 1.72 |
Secondary
Fold-Change in CXCL1 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CXCL1 at week 16 as compared to baseline.
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in CXCL1 Level | 1.12 fold-change | Standard Error 1.71 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in CXCL1 Level | -2.72 fold-change | Standard Error 2.02 |
| Secukinumab Only for Extrinsic AD | Fold-Change in CXCL1 Level | 1.31 fold-change | Standard Error 1.45 |
| Secukinumab Only for Intrinsic AD | Fold-Change in CXCL1 Level | -1.38 fold-change | Standard Error 1.67 |
Secondary
Fold-Change in Elafin/Pi3 Level From Baseline
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of elafin/Pi3 at week 16 as compared to baseline
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in Elafin/Pi3 Level From Baseline | -1.00 fold-change | Standard Error 2.06 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in Elafin/Pi3 Level From Baseline | -7.90 fold-change | Standard Error 2.6 |
| Secukinumab Only for Extrinsic AD | Fold-Change in Elafin/Pi3 Level From Baseline | 1.3 fold-change | Standard Error 1.66 |
| Secukinumab Only for Intrinsic AD | Fold-Change in Elafin/Pi3 Level From Baseline | -2.65 fold-change | Standard Error 2 |
Secondary
Fold-Change in K16 Expression of Lesional Skin
Epidermal hyperplasia assessed using change in the epidermal proliferation marker Ki67 at week 16 as compared to baseline. Staining quantification was performed with ImageJ 1.42
Time frame: at Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in K16 Expression of Lesional Skin | 1.14 fold-change | Standard Error 1.89 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in K16 Expression of Lesional Skin | -3.96 fold-change | Standard Error 2.33 |
| Secukinumab Only for Extrinsic AD | Fold-Change in K16 Expression of Lesional Skin | 1.36 fold-change | Standard Error 1.56 |
| Secukinumab Only for Intrinsic AD | Fold-Change in K16 Expression of Lesional Skin | -1.3 fold-change | Standard Error 1.84 |
Secondary
Fold-Change in S100A7 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of S100A7 at week 16 as compared to baseline.
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Fold-Change in S100A7 Level | -1.13 fold-change | Standard Error 1.83 |
| Placebo Then Secukinumab for Intrinsic AD | Fold-Change in S100A7 Level | -5.25 fold-change | Standard Error 2.24 |
| Secukinumab Only for Extrinsic AD | Fold-Change in S100A7 Level | 1.43 fold-change | Standard Error 1.52 |
| Secukinumab Only for Intrinsic AD | Fold-Change in S100A7 Level | -2.59 fold-change | Standard Error 1.79 |
Secondary
Number of Patients Who Achieve EASI-50 Score
The proportion of patients who achieve an improvement of 50% or greater from their Baseline EASI score up to week 52. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity.
Time frame: Week 4, Week 16, Week 32, Week 52
Population: data for participants who returned for the respective week visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 32 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 52 | 1 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 4 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 16 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 52 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 4 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 16 | 1 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 32 | 2 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 4 | 1 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 52 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 16 | 3 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 32 | 0 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 16 | 4 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 52 | 1 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 32 | 1 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients Who Achieve EASI-50 Score | Week 4 | 0 Participants |
Secondary
Number of Patients With SCORAD-50
The proportion of patients who achieve an improvement of 50% or greater from their Baseline objective SCORAD up to week 52. SCORing Atopic Dermatitis (SCORAD) -The intensity part of the SCORAD index consists of six items: erythema, edema⁄papulation, excoriations, lichenification, oozing⁄crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms.
Time frame: Week 4, Week 16, Week 32, Week 52
Population: data for participants who returned for the respective week visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With SCORAD-50 | Week 16 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With SCORAD-50 | Week 32 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With SCORAD-50 | Week 4 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With SCORAD-50 | Week 52 | 1 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With SCORAD-50 | Week 4 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With SCORAD-50 | Week 16 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With SCORAD-50 | Week 52 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With SCORAD-50 | Week 32 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With SCORAD-50 | Week 16 | 3 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With SCORAD-50 | Week 52 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With SCORAD-50 | Week 4 | 2 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With SCORAD-50 | Week 32 | 0 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With SCORAD-50 | Week 32 | 1 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With SCORAD-50 | Week 16 | 2 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With SCORAD-50 | Week 52 | 1 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With SCORAD-50 | Week 4 | 0 Participants |
Secondary
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
The proportion of patients who achieve a score of clear-0 or almost clear-1 in the static IGA score at Week 16 as compared to Baseline. The static IGA score represents an overall static evaluation of dermatitis, performed by the investigator at each visit. It utilizes a scale of 6-points; total scale ranging from 0 (clear) to 5 (very severe disease).
Time frame: Week 16, Week 32, Week 52
Population: data for participants who returned for the respective week visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 16 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 52 | 0 Participants |
| Placebo Then Secukinumab for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 32 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 16 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 52 | 0 Participants |
| Placebo Then Secukinumab for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 32 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 32 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 16 | 0 Participants |
| Secukinumab Only for Extrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 52 | 0 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 16 | 1 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 52 | 0 Participants |
| Secukinumab Only for Intrinsic AD | Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1 | Week 32 | 0 Participants |
Secondary
Percentage Change From Baseline in EASI Scores
Percentage change in EASI scores at Week 16 as compared to baseline. Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity.
Time frame: at Week 16
Population: Data analysis only for those who returned for Week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Percentage Change From Baseline in EASI Scores | 5.27 percentage change | Standard Error 12.71 |
| Placebo Then Secukinumab for Intrinsic AD | Percentage Change From Baseline in EASI Scores | -28.74 percentage change | Standard Error 15.01 |
| Secukinumab Only for Extrinsic AD | Percentage Change From Baseline in EASI Scores | -4.96 percentage change | Standard Error 7.54 |
| Secukinumab Only for Intrinsic AD | Percentage Change From Baseline in EASI Scores | -16.9 percentage change | Standard Error 18.92 |
Secondary
Percentage Change From Baseline in SCORAD Score
Percentage change in SCORAD scores at Week 16 as compared to baseline. SCORing Atopic Dermatitis (SCORAD) full score is 0-103, with higher score indicating more symptoms.
Time frame: at Week 16
Population: data for participants who returned for the week 16 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Secukinumab for Extrinsic AD | Percentage Change From Baseline in SCORAD Score | -3.19 percentage change | Standard Error 9.92 |
| Placebo Then Secukinumab for Intrinsic AD | Percentage Change From Baseline in SCORAD Score | -27.31 percentage change | Standard Error 7.48 |
| Secukinumab Only for Extrinsic AD | Percentage Change From Baseline in SCORAD Score | -8.54 percentage change | Standard Error 6.22 |
| Secukinumab Only for Intrinsic AD | Percentage Change From Baseline in SCORAD Score | -6.11 percentage change | Standard Error 13.85 |