Trials / Recruiting
RecruitingNCT05551793
Regeneron AA Multicenter (Dupilumab)
Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Emma Guttman · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | Dupilumab: 300mg SC injections |
| DRUG | Placebo | Placebo: SC injections of equivalent volume |
Timeline
- Start date
- 2023-04-10
- Primary completion
- 2027-11-03
- Completion
- 2027-11-03
- First posted
- 2022-09-23
- Last updated
- 2025-07-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05551793. Inclusion in this directory is not an endorsement.