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New treatment option for Alopecia Areata
Official title Dupilumab in the Treatment of Pediatric Alopecia Areata
ClinicalTrials.gov ID: NCT05866562
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, being studied as a potential treatment for alopecia areata.
Also referred to as Dupixent.
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 four 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. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Male or female participants who are at least 6 years old and under 18 years old, who can provide assent (if appropriate), and for whom signed...
- 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)...
- Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]);
- Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.
You likely can't join if
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Participant is pregnant or breastfeeding.
- Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related...
- Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
- Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of...
- Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic...
See the full eligibility criteria
- Male or female participants who are at least 6 years old and under 18 years old, who can provide assent (if appropriate), and for whom signed informed consent can be provided by parent or legal guardian prior to...
- 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]);
- Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.
- Participant has a screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Participant is pregnant or breastfeeding.
- Participant'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...
- Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.
- Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of life-threatening asthma exacerbations while on appropriate...
- Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
- Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
- Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for people determined by the investigators to be at high-risk for this disease.
- Participant 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...
- Participant has received a live attenuated vaccine ≤ 28 days prior to study randomization.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- History of adverse systemic or allergic reactions to any component of the study drug.
- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitor...
- Participant has been previously treated with dupilumab
- Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- San Diego, California, United States
- Chicago, Illinois, United States
- New York, 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, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; San Diego, California, United States; Chicago, Illinois, United States; New York, 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.