Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
Emma Guttman
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: * Male or female subjects who are at least 18 years old at the time of informed consent. * Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. * Subject is able to adhere to the study visit schedule and other protocol requirements. * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in w…
Interventions
- DrugDupilumab
Dupilumab: 300mg SC injections
- DrugPlacebo
Placebo: SC injections of equivalent volume
Locations (3)
- University of California, IrvineIrvine, California
- Icahn School of Medicine at Mount SinaiNew York, New York
- UR Dermatology at College TownRochester, New York