Regeneron AA Multicenter (Dupilumab)

Part of paid clinical trials in Irvine, California.

Sponsor
Emma Guttman
Study ID
NCT05551793
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Dupilumab: 300mg SC injections
  • Placebo — DRUG
    Placebo: SC injections of equivalent volume

Study 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 ≥ 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).

Key Dates

Start date
Apr 10, 2023
Status verified
Jul 2025
Primary completion
Nov 3, 2027
Completion
Nov 3, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron
  • Placebo Comparator: Placebo
    Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron

Primary Outcome Measure

Change in the SALT score [ Time Frame: Baseline and Week 48 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Jamy Paniagua
[email protected]
(949) 824-7103
Natasha A Mesinkovska, MD PhD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Giselle Singer
[email protected]
212-241-3288
Emma Guttman-Yassky (PRINCIPAL_INVESTIGATOR)
UR Dermatology at College TownRochesterNew York14620
Alicia Papalia
[email protected]
585-273-4195
Lisa Beck (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
University of California, Irvine· Irvine, CAIcahn School of Medicine at Mount Sinai· New York, NYUR Dermatology at College Town· Rochester, NY

Related Studies