Clinical trial NCT02594098: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
extrinsic atopic dermatitis
intrinsic atopic dermatitis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2015-11-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fold-Change in Epidermal Thickness of Lesional Skin
timeFrame: at Week 16
Secondary outcomes:
measure: Fold-Change in K16 Expression of Lesional Skin
timeFrame: at Week 16
measure: Number of Patients With SCORAD-50
timeFrame: Week 4, Week 16, Week 32, Week 52
measure: Number of Patients Who Achieve EASI-50 Score
timeFrame: Week 4, Week 16, Week 32, Week 52
measure: Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
timeFrame: Week 16, Week 32, Week 52
measure: Percentage Change From Baseline in SCORAD Score
timeFrame: at Week 16
measure: Percentage Change From Baseline in EASI Scores
timeFrame: at Week 16
measure: Fold-Change in Elafin/Pi3 Level From Baseline
timeFrame: at Week 16
measure: Fold-Change in CCL20 Level
timeFrame: at Week 16
measure: Fold-Change in CXCL1 Level
timeFrame: at Week 16
measure: Fold-Change in S100A7 Level
timeFrame: at Week 16
measure: Fold-Change in A8 Level
timeFrame: at Week 16
measure: Fold-Change in A9 Level
timeFrame: at Week 16
measure: Fold-Change in A12 Level
timeFrame: at Week 16
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Emma Guttman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: