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.