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Dupilumab in the Treatment of Pediatric Alopecia Areata

Study acronym: PEDAL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 17, 2028 → Mar 31, 2029
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 17, 2028 to Mar 31, 2029
    • Site contacts updated at 1 of 5 sites
    • Collaborators expanded, about 8 words
    v10
  2. Primary completion date: May 3, 2027 to Aug 17, 2028
    • Study completion date: Sep 18, 2028 to Apr 30, 2029
    v9
  3. Primary completion date: May 30, 2028 to May 3, 2027
    • Study sites: 4 to 5
    • Study completion date: May 30, 2029 to Sep 18, 2028
    v8
  4. Site details revised at 1 of 4 sitesv7
  5. Study sites: 5 to 4v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 4 to 5v5
  2. Primary completion date: Apr 30, 2028 to May 30, 2028
    • Study completion date: Apr 30, 2029 to May 30, 2029
    • Start date changed from estimate of Jun 24, 2024 to Jul 11, 2024
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 15, 2024 to Jun 24, 2024
    • Site details revised at 4 of 4 sites
    v3
  4. Primary completion date: Jun 2026 to Apr 30, 2028v2 Show 5 more changesShow less
    • Start date: Mar 2024 to Jun 15, 2024
    • Study completion date: Sep 2027 to Apr 30, 2029
    • Eligibility criteria shortened, about 61 words
    • Secondary endpoints: 18 to 12
    • Site contacts updated at 4 of 4 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05866562
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Alopecia Areata
Related terms Alopecia Areata
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov