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NCT05866562 · ClinicalTrials.gov registry record · Phase 2
Dupilumab in the Treatment of Pediatric Alopecia Areata
A Phase 2 study of Alopecia Areata, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 5
- Study locations
NCT05866562: Recruiting Phase 2 study of Alopecia Areata, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05866562 is a Phase 2 study of Alopecia Areata that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 76 participants, below the 1,952-participant average among 26 other Alopecia Areata trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05866562, a Phase 2 study of Alopecia Areata, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. 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. All subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥200 and/or have personal and/or familial history of atopy. Study participation will be up to 124 weeks, consisting of: a screening period of up to 4 weeks; a 48-week placebo-controlled period; a 48-week open-label extension period; followed by a 24-week follow-up period.
Primary Outcome
Change in the SALT score from baseline compared to Week 48 in Dupilumab treated vs placebo treated subjects. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), r
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (5)
California
- University of California, Irvine - Irvine
- University of California San Diego - San Diego
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 2 |
What NCT05866562 shows while recruiting
NCT05866562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,952-participant average among 26 other Alopecia Areata trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05866562 lists 5 locations in 3 states (California, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT05866562 about?
NCT05866562 is a clinical study titled "Dupilumab in the Treatment of Pediatric Alopecia Areata". This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. 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 part...
What is the current status of trial NCT05866562?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2024-07-11. Estimated completion is 2029-04-30.
What conditions does trial NCT05866562 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT05866562?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05866562?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05866562 being conducted?
This trial has 5 study locations across California, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05866562's enrollment target sits among peer trials
76 16th of 26 higher than 11 of 26 other Alopecia Areata trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alopecia Areata trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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