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Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

Study acronym: PROSE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Mar 30, 2027 to Jul 28, 2027 Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 3 of 20 entries · Publications: details revised at 3 of 3 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 20 entries
    • Publications: details revised at 3 of 3 entries
  2. 3 versions Re-verified since Sep 27, 2023, no change to tracked fieldsv11-v13
  3. Study sites: 78 to 99v10
  4. Enrollment target: estimated 1000 to confirmed 858 Primary and study completion dates: Jun 9, 2027 to Mar 30, 2027v9 Show 1 more changeShow less
    • Primary and study completion dates: Jun 9, 2027 to Mar 30, 2027
  5. Primary and study completion dates: Nov 13, 2025 to Jun 9, 2027 Trial status: Recruiting to Active, Not Recruiting · Study sites: 99 to 78v8 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 99 to 78
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 6 of 99 sitesv7
  2. Study sites: 98 to 99 Primary and study completion dates: Dec 31, 2025 to Nov 13, 2025v6 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2025 to Nov 13, 2025
  3. Study sites: 69 to 98v5
  4. Primary and study completion dates: Dec 2, 2023 to Dec 31, 2025 Study sites: 2 to 69 · Eligibility criteria expanded, about 95 words · Secondary endpoints: 13 to 20 · 2 morev4 Show 5 more changesShow less
    • Study sites: 2 to 69
    • Eligibility criteria expanded, about 95 words
    • Secondary endpoints: 13 to 20
    • Study description shortened, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Feb 2018 to Apr 6, 2018v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 2018 to Apr 6, 2018
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Regeneron
151 trials monitored
See 16 trials at risk
Atopic Dermatitis
491 trials monitored
See 14 trials at risk
A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
Trial Details
NCT Number NCT03428646
Lead Sponsor Regeneron Pharmaceuticals
Collaborators: Sanofi
Conditions Dermatitis, Atopic
Enrollment 858 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov