Regeneron AA Multicenter (Dupilumab)
- Registration Number
- NCT05551793
- Lead Sponsor
- Emma Guttman
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron Placebo Placebo Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron
- Primary Outcome Measures
Name Time Method Change in the SALT score Baseline and Week 48 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.
- Secondary Outcome Measures
Name Time Method Number of patients achieving an absolute SALT score of ≤ 20 Week 48 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.
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score Weeks 64 up to 96 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.
Change in the Alopecia Areata Symptom Impact Scale (AASIS) Baseline and Week 48 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.
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL) Baseline and Week 48 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).
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores Baseline and Week 48 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.
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores Baseline to Week 48 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.
Change in Eyelash Assessment Score Weeks 16 up to 48 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.
Change in Eyebrow Assessment Score Weeks 16 up to 48 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.
Number of adverse events reported Baseline up to Week 96 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.
Trial Locations
- Locations (3)
University of California, Irvine
🇺🇸Irvine, California, United States
UR Dermatology at College Town
🇺🇸Rochester, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States