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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 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.

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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.

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

FieldValue
Enrollment Target 76 participants
Start Date 2024-07-11
Est. Completion 2029-04-30
Phase Phase 2

What the Registry Record Tells You About NCT05866562

The ClinicalTrials.gov registry entry for NCT05866562 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,952-participant average among 26 other Alopecia Areata trials with a reported enrollment target (96% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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