Clinical Trial: A Study of Secukinumab for the Treatment of Alopecia Areata

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome: Severity of Alopecia Tool (SALT) score [ Time Frame: Week 24 ]

percentage of regrowth of scalp hair based on percentage of patients achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SALT score [ Time Frame: week 24 ]
    Achieving a SALT score of 90 at week 24
  • SALT score [ Time Frame: week 28 ]
    Achieving a SALT score of 90 at week 28
  • Physician's Global Assessment (PGA) score [ Time Frame: Week 24 ]
    Proportion 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).
  • Dermatology Life Quality Index (DLQI) [ Time Frame: Week 24 ]
    Proportion 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).


Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: November 4, 2015
Date Started: November 2015
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017