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Regeneron AA Multicenter (Dupilumab)

NCT05551793 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-07-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Dupilumab

Dupilumab: 300mg SC injections

DRUG

Placebo

Placebo: SC injections of equivalent volume

Sponsors & Collaborators

Principal Investigators

  • Emma Guttman-Yassky, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2027-11-03
Completion
2027-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05551793 on ClinicalTrials.gov