Phase 2: testing Dupilumab for Alopecia Areata
This is a prospective, randomly assigned, double blind, compared with a dummy treatment clinical trial. 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.
Official registry: https://clinicaltrials.gov/study/NCT05551793 · Emma Guttman · 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, double blind, compared with a dummy treatment clinical trial.
They plan to enroll about 76 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
Interventions: Dupilumab, Placebo
Primary outcome (registry wording): Change in the SALT score
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Subject 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;
- 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)
Who the registry excludes
- 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
Public study contact (from the registry)
Giselle Singer
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- University of California, Irvine — Irvine, California (recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York (recruiting)
- UR Dermatology at College Town — Rochester, New York (recruiting)
FAQ about this NCT record
Is NCT05551793 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 NCT05551793?
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 NCT05551793?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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