Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT03359356
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    A total of 24 doses
  • Placebo — DRUG
    A total of 24 doses

Study Details

Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families. In this study, the aim is to assess the effects of dupilumab in patients with alopecia areata.

Key Dates

Start date
Jan 9, 2018
Status verified
Aug 2022
Primary completion
Jan 14, 2020
Completion
Dec 17, 2020

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    An initial dupilumab dose of 600 mg (two 300 mg subcutaneous injections), followed by dupilumab 300 mg given every week
  • Placebo Comparator: Placebo
    Matching placebo in prefilled syringes identical to the dupilumab syringes

Primary Outcome Measure

Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 [ Time Frame: Baseline and 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
The Rockefeller University Laboratory for Investigative DermatologyNew YorkNew York10065-6399-

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NYThe Rockefeller University Laboratory for Investigative Dermatology· New York, NY

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