Dupilumab in the Treatment of Alopecia Areata Patients with an atopic background and/or High IgE
Details
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 greater than or equal to 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
You can join if...
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 which conception is possible must use one of the approved contraceptive options described below:
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;
Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
Subject has a history of at least 6 months of moderate to severe AA (greater than or equal to 50% scalp involvement) as measured using the SALT score; OR subject has greater than or equal to; 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes.
Subject has a screening IgE > 200 and/or personal and/or familial history of atopy.
Subjects must meet the laboratory criteria
Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Other protocol-defined Inclusion/ Exclusion Criteria apply