Actively Recruiting
Regeneron AA Multicenter (Dupilumab)
Led by Emma Guttman · Updated on 2025-07-29
68
Participants Needed
3
Research Sites
238 weeks
Total Duration
On this page
Sponsors
E
Emma Guttman
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Regeneron AA Multicenter (Dupilumab)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects at least 18 years old at the time of consent
- Ability to understand and voluntarily sign informed consent
- Ability to follow study visit schedule and protocol requirements
- Females of childbearing potential must have a negative pregnancy test at screening and baseline
- Females of childbearing potential must use approved contraceptive methods during and for 28 days after treatment
- Females not of childbearing potential must have documented infertility, menopause for one year, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
- History of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) or ≥ 95% scalp hair loss for AA totalis or universalis
- Screening IgE ≥ 200 and/or personal or familial history of atopy
- Laboratory criteria: WBC count ≥ 3000/mm3 and < 14000/mm3, platelet count ≥ 100,000/μL, serum creatinine ≤ 1.5 mg/dL, AST and ALT ≤ 2 times upper limit of normal (one repeat allowed if initially elevated), total bilirubin ≤ 2 mg/dL (one repeat allowed if initially elevated), hemoglobin ≥ 10 g/dL
- Overall good health based on medical history, physical exam, and lab tests
You will not qualify if you...
- Pregnant or breastfeeding
- Hair loss cause unclear or due to other types like traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia
- History of AA without hair regrowth for 7 or more years since last episode
- Severe, uncontrolled asthma or life-threatening asthma exacerbations while on medication
- Active bacterial, viral, or parasitic infections or history of recurrent severe infections needing systemic antibiotics
- Known or suspected immunodeficiency or immune-compromised state
- Severe, progressive, or uncontrolled major organ diseases
- Active hepatitis B, hepatitis C, HIV infection, or untreated latent tuberculosis
- Suspected or active lymphoproliferative disorder or malignancy; history of malignancy within 5 years except certain treated skin or cervical cancers
- Received live attenuated vaccine within 30 days before randomization
- Significant lab abnormalities affecting study data interpretation
- Any medical or psychological condition posing additional risk or interfering with participation
- History of severe allergic reactions to study drug components
- Use of systemic immunosuppressive medications within 4 weeks prior to randomization
- Use of oral JAK inhibitors within 12 weeks before baseline
- Previous treatment with dupilumab
- Use of topical corticosteroids, tacrolimus, or pimecrolimus within 1 week before baseline
- Current or planned use of anti-retroviral therapy during the study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
3
UR Dermatology at College Town
Rochester, New York, United States, 14620
Actively Recruiting
Research Team
G
Giselle Singer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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