A Study of Secukinumab for the Treatment of Alopecia Areata

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata Read More

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.