A Study of Secukinumab for the Treatment of Alopecia Areata

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02599129
• Date of registration: 04/11/2015
• Prospective Registration: No
• Primary sponsor: Icahn School of Medicine at Mount Sinai
• Public title: A Study of Secukinumab for the Treatment of Alopecia Areata
• Scientific title: An Exploratory Study to Evaluate the Safety and Efficacy of Secukinumab in the Treatment of Extensive Alopecia Areata
• Date of first enrolment: November 2015
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02599129
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Mark Lebwohl, MD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Alopecia Areata

Intervention(s)

Drug: Placebo

Drug: Secukinumab

Primary Outcome(s)

Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50 [Time Frame: Week 24]

Secondary Outcome(s)

Number of Subjects Achieving a SALT Score of 90 at Week 28 [Time Frame: week 28]

Number of Subjects Achieving a SALT Score of 90 at Week 24 [Time Frame: week 24]

Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above [Time Frame: Week 24]

Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above [Time Frame: Week 24]

Secondary ID(s)

GCO 15-0549

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis

Results

• Results available: Yes
• Date Posted: 30/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02599129