Phase 2: testing Dupilumab for Alopecia Areata
This is a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48.
Official registry: https://clinicaltrials.gov/study/NCT05866562 · Icahn School of Medicine at Mount Sinai · enrollment listed as 76
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. This is a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial.
They plan to enroll about 76 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Dupilumab in the Treatment of Pediatric Alopecia Areata
Interventions: Dupilumab, Placebo
Primary outcome (registry wording): Change in the Severity of Alopecia Tool (SALT) score
Who it is for (from inclusion criteria)
- Ages 6 Years to 17 Years
- \-- Participant is able to adhere to the study visit schedule and other protocol requirements
- 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
Who the registry excludes
- 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. Ludwig Type III or Norwood-Hamilton Stage ≥ V)
- 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 anti-asthmatic medications
- 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
Public study contact (from the registry)
Benjamin Ungar, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
5 listed- University of California, Irvine — Irvine, California (recruiting)
- University of California San Diego — San Diego, California (recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois (recruiting)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois (recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York (recruiting)
FAQ about this NCT record
Is NCT05866562 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05866562?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05866562?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary