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RECRUITING
NCT05551793
PHASE2

Regeneron AA Multicenter (Dupilumab)

Sponsor: Emma Guttman

View on ClinicalTrials.gov

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).

Official title: Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2023-04-10

Completion Date

2027-11-03

Last Updated

2025-07-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dupilumab

Dupilumab: 300mg SC injections

DRUG

Placebo

Placebo: SC injections of equivalent volume

Locations (3)

University of California, Irvine

Irvine, California, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

UR Dermatology at College Town

Rochester, New York, United States