Secukinumab for Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Secukinumab; Placebo
Intervention description: At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.; At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic dermatitis; extrinsic atopic dermatitis; intrinsic atopic dermatitis

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.
    

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.