Emma Guttman
Emma Guttman
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).
Alopecia Areata
Dupilumab
Placebo
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 68 participants |
Masking : | Triple |
Primary Purpose : | Treatment |
Official Title : | Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE |
Actual Study Start Date : | April 10, 2023 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Dupilumab Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron |
Drug: Dupilumab |
Placebo Comparator: Placebo Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron |
Drug: Placebo |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Recruiting
UR Dermatology at College Town
Rochester, New York, United States, 14620