A Study of Secukinumab for the Treatment of Alopecia Areata

An Exploratory Study to Evaluate the Safety and Efficacy of Secukinumab in the Treatment of Extensive Alopecia Areata

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.

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Secukinumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secukinumab; 300 mg subcutaneous injections	Drug: Secukinumab; subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
Placebo Comparator: Placebo; matching placebo subcutaneous injections	Drug: Placebo; subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50	Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieving a SALT Score of 90 at Week 24	We assessed the Number of subjects that achieved a SALT score of 90 at week 24	week 24
Number of Subjects Achieving a SALT Score of 90 at Week 28	We assessed the Number of subjects that achieved a SALT score of 90 at Week 28	week 28
Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above	Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).	Week 24
Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above	Number of subjects achieving a DLQI (Dermatology Life Quality Index), patient global assessment score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).	Week 24

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Alopecia areata
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: GCO 15-0549