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| ID | Type | Description | Link |
|---|---|---|---|
| CAIN457AUS02T | Other Identifier | Novartis Pharmaceuticals Corporation |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes |
|
| Placebo | Placebo Comparator | Placebo via subcutaneous injection using 2 prefilled syringes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fold-Change in Epidermal Thickness of Lesional Skin | Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline | at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Week 16 |
| Number of Patients With SCORAD-50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Guttman, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab Extrinsic | 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. |
| FG001 | Placebo Then Secukinumab Extrinsic | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Fold-Change in Epidermal Thickness of Lesional Skin | Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline | Data only for those that returned for week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
up to 52 weeks
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orbital Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emma Guttman | Icahn School of Medicine at Mount Sinai | 212-241-9728 | emma.guttman@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2015 | Apr 15, 2019 | Prot_SAP_000.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 |
|---|---|
| C555450 | secukinumab |
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| Placebo | Drug | At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study. |
|
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. |
| Week 4, Week 16, Week 32, Week 52 |
| 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. | Week 4, Week 16, Week 32, Week 52 |
| 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). | Week 16, Week 32, Week 52 |
| 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. | at Week 16 |
| 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. | at Week 16 |
| 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 | at Week 16 |
| 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. | at Week 16 |
| 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. | at Week 16 |
| 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. | at Week 16 |
| 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 | at Week 16 |
| 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. | at Week 16 |
| 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 | at Week 16 |
| Terminated participation |
|
| Seek alternative treatment |
|
| Other |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Eczema Area and Severity Index (EASI) score | 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. | Mean | Standard Deviation | units on a scale |
|
| SCORing Atopic Dermatitis (SCORAD) score | SCORing Atopic Dermatitis -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. | Mean | Standard Deviation | units on a scale |
|
| IgE level | Intrinsic Atopic Dermatitis IgE =< 500 kU/L; Extrinsic Atopic Dermatitis, IgE > 500 kU/L | Mean | Standard Deviation | kU/L |
|
| OG001 | Placebo Then Secukinumab for Intrinsic AD | 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. |
| OG002 | Secukinumab Only for Extrinsic AD | 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. |
| OG003 | Secukinumab Only for Intrinsic AD | 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. |
|
|
| 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 | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
|
|
| 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. | data for participants who returned for the respective week visit | Posted | Count of Participants | Participants | Week 4, Week 16, Week 32, Week 52 |
|
|
|
| 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. | data for participants who returned for the respective week visit | Posted | Count of Participants | Participants | Week 4, Week 16, Week 32, Week 52 |
|
|
|
| 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). | data for participants who returned for the respective week visit | Posted | Count of Participants | Participants | Week 16, Week 32, Week 52 |
|
|
|
| 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. | data for participants who returned for the week 16 visit | Posted | Mean | Standard Error | percentage change | at Week 16 |
|
|
|
| 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. | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | percentage change | at Week 16 |
|
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| 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 | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
|
|
| 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. | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
|
|
| 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. | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
|
|
| 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. | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
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| 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 | Data analysis only for those who returned for Week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
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| 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. | data only for those who returned for week 16 visit | Posted | Mean | Standard Error | fold-change | at Week 16 |
|
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| 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 | Posted | Mean | Standard Error | fold-change | at Week 16 |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 3 | 27 |
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Streptococcal Pharyngitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| 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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| Week 32 |
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| Week 52 |
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| Week 32 |
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| Week 52 |
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| Week 52 |
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