Secukinumab for Treatment of Atopic Dermatitis

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.

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.