A Study of Secukinumab for the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Secukinumab; Placebo
Intervention description: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.; ￼subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alopecia areata

Summary:

      Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can
      fall out on the scalp or elsewhere on the face and body.

      Alopecia areata is an autoimmune skin disease, which means that the immune system is
      recognizing the hair follicles as foreign and attacking them, causing round patches of hair
      loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss
      (alopecia universalis). The scalp is the most commonly affected area, but the beard or any
      hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in
      males and females of all ages, and is a highly unpredictable condition that tends to recur.
      Alopecia areata can cause significant distress to both patients and their families.

      Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia
      areata. A total of 30 patients will be included in the study, which will run for a total of
      28 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.

          -  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.

          -  Subject with AA (unequivocal cases of AA), affecting at least 60% of the scalp, and
             present for at least 6 months.

          -  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.

        Exclusion Criteria:

          -  Other concomitant types of alopecia (androgenetic, female pattern, traction, scarring
             and others)

          -  Any subject who is pregnant or refuses to practice an acceptable method of birth
             control (as stated in inclusion criterion # 4)

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             tuberculosis infection as defined by a positive tuberculin purified protein derivative
             (PPD) or QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive or
             indeterminate PPD or QFT test may participate in the study if a full tuberculosis work
             up (according to local practice/guidelines) is completed within 12 weeks prior to
             randomization and establishes conclusively that the subject has no evidence of active
             tuberculosis. If presence of latent tuberculosis is established, then treatment must
             have been initiated at least for 4 weeks prior to randomization and the course of
             prophylaxis is planned to be completed.

          -  Active Crohn's disease

          -  Known hypersensitivity to latex

          -  Subjects with a history of HIV, or history of positive HCV or HBV

          -  Previous exposure to Secukinumab or other drug targeting IL-17A or its receptor; use
             of sensitizing therapy for alopecia areata including DPCP, squaric acid, DNCB within 1
             month; PUVA, or any form of phototherapy within 1 month; use of any immunosuppressive
             therapies (systemic corticosteroids, methotrexate, azathioprine, mycophenolate
             mofetil, cyclosporine) within 1 month; or use of topical therapies (two weeks). All
             the above therapies will not be allowed during this study.