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A Study of Secukinumab for the Treatment of Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02599129
Recruitment Status : Terminated (low enrollment)
First Posted : November 6, 2015
Results First Posted : November 30, 2017
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mark Lebwohl, Icahn School of Medicine at Mount Sinai

Brief 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.


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Secukinumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Safety and Efficacy of Secukinumab in the Treatment of Extensive Alopecia Areata
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

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.




Primary Outcome Measures :
  1. Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50 [ Time Frame: Week 24 ]
    Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24


Secondary Outcome Measures :
  1. Number of Subjects Achieving a SALT Score of 90 at Week 24 [ Time Frame: week 24 ]
    We assessed the Number of subjects that achieved a SALT score of 90 at week 24

  2. Number of Subjects Achieving a SALT Score of 90 at Week 28 [ Time Frame: week 28 ]
    We assessed the Number of subjects that achieved a SALT score of 90 at Week 28

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599129


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Novartis
Investigators
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Principal Investigator: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Mark Lebwohl, Professor and System Chair, Dermatology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02599129    
Other Study ID Numbers: GCO 15-0549
First Posted: November 6, 2015    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: March 11, 2021
Last Verified: February 2021
Keywords provided by Mark Lebwohl, Icahn School of Medicine at Mount Sinai:
Alopecia areata
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical