Allergy drug dupilumab tested as potential hair loss treatment
NCT ID NCT05551793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether dupilumab, a drug used for allergies and eczema, can help regrow hair in people with moderate-to-severe alopecia areata who also have allergies or high IgE levels. Participants receive weekly injections of dupilumab or a placebo for 48 weeks, followed by an additional 48 weeks of dupilumab for all. The main goal is to measure changes in scalp hair loss using the SALT score.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab
- What this could lead to
- If successful, dupilumab could offer a new treatment option for people with alopecia areata who also have allergies or high IgE levels.
- What could go wrong
- This is a Phase 2 trial with a small number of participants. The drug may not work for everyone, and side effects like injection reactions or eye inflammation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: * Male or female subjects who are at least 18 years old at the time of informed consent. * Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures. * Subject is able to adhere to the study visit schedule and other protocol requirements. * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: * Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR; * Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. * If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. * Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score; OR subject has ≥ 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes. * Subject has a screening IgE \> 200 and/or personal and/or familial history of atopy. * Subjects must meet the following laboratory criteria: * White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (≤ 14 x 109/L). * Platelet count ≥ 100,000/μL (≥ 100 x 109/L). * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L). * AST (SGOT) and ALT (SGPT) ≤ 2 x upper limit of normal (ULN). If the initial test shows ALT or AST \> 2 times the ULN, one repeat test is allowed during the Screening Phase. * Total bilirubin ≤ 2 mg/dL (34 μmol/L). If the initial test shows total bilirubin \> 2 mg/dL (34 μmol/L), one repeat test is allowed during the Screening Phase. * Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L). * Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing. EXCLUSION CRITERIA: The presence of any of the following will exclude a subject from enrollment: * Subject is pregnant or breastfeeding. * Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V). * Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss. * Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations. * Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics * Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator. * Subject has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease. * Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology or active or untreated latent tuberculosis at the time of screening for subjects determined by the investigators to be at high-risk for this disease. * Subject has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis. * Subject has received a live attenuated vaccine ≤ 30 days prior to study randomization. * Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints. * Subject has any other medical or psychological condition that, in the opinion of the investigator, may present additional unreasonable risks as a result of their participation in the study and/or interfere with clinic visits and necessary study assessments. * History of adverse systemic or allergic reactions to any component of the study drug. * Severe, untreated asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations. * Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to randomization. * Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, or investigational oral JAK Inhibitors) within 12 weeks prior to the Baseline visit. * Subject has been previously treated with dupiliumab. * Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit. * Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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UR Dermatology at College Town
RECRUITINGRochester, New York, 14620, United States
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University of California, Irvine
RECRUITINGIrvine, California, 92697, United States
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