Clinical Trial: Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Placebo-controlled Single Center Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe 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.

In this study, the aim to assess the effects of a new treatment called apremilast in patients with alopecia areata. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.


Detailed Summary:

This is a randomized, double-blind, placebo-controlled pilot study consisting of two phases. A total of 30 subjects with moderate to severe alopecia areata (including universalis and totalis) involving 50-100% of the scalp will be enrolled. A possible maximum of 15 patients (approximately 7 patients each) with current episodes of AA totalis / universalis may be included in this study.

In Phase 1, subjects will be randomized (2:1) to either receive apremilast or placebo for 24 weeks.

In Phase 2, eligible subjects will receive apremilast from Week 24 through Week 48. The following subjects will be eligible to enter into Phase 2:

  1. Subjects who received placebo in Phase 1 of the study
  2. Subjects who received apremilast in Phase 1 of the study, and who achieved a minimum of 50% regrowth (SALT50) at Week 24, compared to Baseline.

Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome: SALT50 [ Time Frame: Baseline and Week 24 ]

Percentage of patients achieving 50% or greater improvement in their Severity of Alopecia Tool (SALT) score (SALT50) at Week 24 compared to Baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • aaPGA [ Time Frame: Week 24 ]
    2) Proportion of subjects achieving an alopecia areata Physician's Global Assessment (aaPGA) score of 3 or above at Weeks 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).
  • aaPGA [ Time Frame: Week 48 ]
    2) Proportion of subjects achieving an alopecia areata Physician's Global Assessment (aaPGA) score of 3 or above at Weeks 48 (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).
  • AASIS [ Time Frame: Baseline and Weeks 24 ]
    Percentage change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Weeks 24.
  • AASIS [ Time Frame: Baseline and Weeks 48 ]
    Percentage change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Weeks 48.
  • AA-QoL [ Time Frame: Baseline and Weeks 24 ]
    Percentage change from baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24.
  • AA-QoL [ Time Frame: Baseline and Weeks 48 ]
    Percentage change from baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 48.
  • Semiquantitative score [ Time Frame: Baseline and Weeks 24 ]
    Semiquantitative score using SALT subclasses (0, no hair loss; 1, <25% hair loss; 2, 25%-49% hair loss; 3, 50%-74% hair loss; 4, 75%-99% hair loss; 5, 100% hair loss) at week 24.
  • Semiquantitative score [ Time Frame: Baseline and Weeks 48 ]
    Semiquantitative score using SALT subclasses (0, no hair loss; 1, <25% hair loss; 2, 25%-49% hair loss; 3, 50%-74% hair loss; 4, 75%-99% hair loss; 5, 100% hair loss) at week 48.


Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: February 11, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: April 11, 2017
Last Verified: April 2017