Back to resultsSecukinumab for Treatment of Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Secukinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, extrinsic atopic dermatitis, intrinsic atopic dermatitis
Eligibility Criteria
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.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Secukinumab
Placebo
Arm Description
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
Placebo via subcutaneous injection using 2 prefilled syringes
Outcomes
Primary Outcome Measures
Fold-Change in Epidermal Thickness of Lesional Skin
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Secondary Outcome Measures
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
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.
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.
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).
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.
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.
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
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.
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.
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.
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
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.
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
Full Information
NCT ID
NCT02594098
First Posted
October 30, 2015
Last Updated
May 23, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT02594098
Brief Title
Secukinumab for Treatment of Atopic Dermatitis
Official Title
A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, extrinsic atopic dermatitis, intrinsic atopic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo via subcutaneous injection using 2 prefilled syringes
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
Primary Outcome Measure Information:
Title
Fold-Change in Epidermal Thickness of Lesional Skin
Description
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Time Frame
at Week 16
Secondary Outcome Measure Information:
Title
Fold-Change in K16 Expression of Lesional Skin
Description
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
Title
Number of Patients With SCORAD-50
Description
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
Title
Number of Patients Who Achieve EASI-50 Score
Description
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
Title
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Description
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
Title
Percentage Change From Baseline in SCORAD Score
Description
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
Title
Percentage Change From Baseline in EASI Scores
Description
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
Title
Fold-Change in Elafin/Pi3 Level From Baseline
Description
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
Title
Fold-Change in CCL20 Level
Description
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
Title
Fold-Change in CXCL1 Level
Description
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
Title
Fold-Change in S100A7 Level
Description
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
Title
Fold-Change in A8 Level
Description
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
Title
Fold-Change in A9 Level
Description
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
Title
Fold-Change in A12 Level
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Guttman, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Secukinumab for Treatment of Atopic Dermatitis
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