Overview

This trial is active, not recruiting.

Condition atopic dermatitis
Treatments secukinumab, placebo
Phase phase 2
Sponsor Icahn School of Medicine at Mount Sinai
Collaborator Novartis
Start date November 2015
End date November 2016
Trial size 44 participants
Trial identifier NCT02594098, CAIN457AUS02T, GCO 15-1486

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes
secukinumab
At Weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter through and including Week 12 in phase 1 of the study.
(Placebo Comparator)
Placebo via subcutaneous injection using 2 prefilled syringes
placebo
At Weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter through and including Week 12 in phase 1 of the study.

Primary Outcomes

Measure
Change in epidermal thickness of lesional skin
time frame: at Week 16

Secondary Outcomes

Measure
Change in K16 expression of lesional skin
time frame: at Week 16
SCORAD
time frame: at Week 16
SCORAD
time frame: at Week 32
SCORAD
time frame: at Week 52
EASI score
time frame: at Week 16
EASI score
time frame: at Week 32
EASI score
time frame: at Week 52
static IGA score
time frame: at Week 16
static IGA score
time frame: at Week 32
static IGA score
time frame: at Week 1652
SCORAD/EASI ratio scores
time frame: at Week 16
elafin/Pi3 level
time frame: at Week 16
CCL20 level
time frame: at Week 16
CXCL1 level
time frame: at Week 16
S100A7 level
time frame: at Week 16
A8 level
time frame: at Week 16
A9 level
time frame: at Week 16
A12 level
time frame: at Week 16

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
Principal investigator Emma Guttman, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai.