Regeneron AA Multicenter (Dupilumab)
ConditionAlopecia Areata
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmma Guttman
About this trial
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 criteria
Qualifiers
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.
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR;
Disqualifiers
Subject is pregnant or breastfeeding.
Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).
Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.
Trial design
Treatments tested in this trial
- Dupilumab
- Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emma Guttman
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov