A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
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.
Phase
Phase 4 - refines the treatment to become part of standard care.Inclusion and 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.
- 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
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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