This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥ 200 and/or have personal and/or familial history of atopy. Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
Dupilumab: 300mg SC injections
Placebo: SC injections of equivalent volume
University of California, Irvine
Irvine, California, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGUR Dermatology at College Town
Rochester, New York, United States
RECRUITINGChange in the SALT score
Changes in the SALT score from baseline compared to week 48. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The change between baseline and Week 48 will be compared.
Time frame: Baseline and Week 48
Number of patients achieving an absolute SALT score of ≤ 20
Number of patients achieving an absolute SALT score of ≤ 20. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of ≤ 20 will be calculated.
Time frame: Week 48
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The proportion of patients achieving at least 30%/50%/75%/90% improvement will be calculated from weeks 16 to week 48.
Time frame: Weeks 16 up to 48
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score
SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The proportion of patients achieving at least 30%/50%/75%/90% improvement will be calculated from weeks 64 to week 96.
Time frame: Weeks 64 up to 96
Change in the Alopecia Areata Symptom Impact Scale (AASIS)
Changes in the Alopecia Areata Symptom Impact Scale (AASIS) from baseline compared to Week 48. AASIS scale measures how the severe the subjects feel their alopecia areata symptoms have been in the past week (scale 0-10 where 0 indicates the symptom was not present and 10 indicates the symptom was as bad as you can imagine), where higher scores indicate worse symptoms.
Time frame: Baseline and Week 48
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL)
Changes in the Alopecia Areata Quality of Life questionnaire (AA-QoL) from Baseline compared to Week 48. AA-QoL scale measures how severe the subjects feel their alopecia areata symptoms have been in the past week (scale options: very much, a lot, a little, not at all).
Time frame: Baseline and Week 48
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Changes in Alopecia Areata Physician's Global Assessment (aaPGA) scores from Baseline compared to Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth. The number of patients with a score of 0 or 1 will be compared.
Time frame: Baseline and Week 48
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores between dupilumab-treated group and placebo-treated group from Baseline compared to Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth. The number of patients with a score of 0 or 1 will be compared.
Time frame: Baseline to Week 48
Change in Eyelash Assessment Score
Changes in eyelash scores from Weeks 16 through 48. Eyelash Assessment Score measures hair loss. Scale: 0= None, 1= Minimal eyelashes, 2= Moderate eyelashes, 3= Prominent eyelashes, 4= Very prominent eyelashes. Score change from baseline will be calculated, where higher scores indicate greater eyelash loss.
Time frame: Weeks 16 up to 48
Change in Eyebrow Assessment Score
Changes in eyebrow scores from Weeks 16 through 48. Eyebrow Assessment Score measures hair loss. Scale: 0= None, 1= Minimal eyebrows, 2= Moderate eyebrows, 3= Prominent eyebrows, 4= Very prominent eyebrows. Score change from baseline will be calculated, where higher scores indicate greater eyebrow loss.
Time frame: Weeks 16 up to 48
Number of adverse events reported
Number of adverse events reported throughout the study. The adverse event will be described and categorized as treatment emergent, serious, abnormal in vital signs, and abnormal in lab parameters.
Time frame: Baseline up to Week 96
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