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New treatment option for Alopecia Areata
Official title Regeneron AA Multicenter (Dupilumab)
ClinicalTrials.gov ID: NCT05551793
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for alopecia areata.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people 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...
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring)...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can join
- Male or female people 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...
- 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...
- 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...
- Subject has a screening IgE \> 200 and/or personal and/or familial history of atopy.
- people 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.
What rules you out
- 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...
- 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 people determined by the investigators to be at...
- 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...
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- New York, New York, United States
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; New York, New York, United States; Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.