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Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study

Study acronym: GLOBOSPIN
StatusCompleted
PhaseNot specified
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 110 participants (planned 100)
    • Primary and study completion dates changed from estimate of Sep 22, 2026 to Sep 8, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 21 of 26 entries
    • Site details revised at 1 of 49 sites
  2. Enrollment target: 300 to 100
    • Primary and study completion dates: Jun 29, 2029 to Sep 22, 2026
    • Secondary endpoints: details revised at 22 of 26 entries
    • Study description revised
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 51 to 49
    v9
  4. Study sites: 49 to 51v8
  5. Study sites revised (49)v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites revised (49)v6
  2. Study sites: 44 to 49v5
  3. Enrollment target: 550 to 300v4 Show 5 more changesShow less
    • Primary and study completion dates: Jun 23, 2031 to Jun 29, 2029
    • Primary endpoints: 7 to 5
    • Study sites: 1 to 44
    • Secondary endpoints: details revised at 22 of 26 entries
    • Study description revised
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Jun 5, 2031 to Jun 23, 2031
    • Start date changed from estimate of Nov 3, 2023 to Dec 12, 2023
    v3
  5. Primary completion date: Mar 9, 2026 to Jun 5, 2031
    • Start date: Aug 28, 2023 to Nov 3, 2023
    • Study completion date: Mar 7, 2031 to Jun 5, 2031
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN). The primary objective of this study is to comprehensively characterize the real-world usage of dupilumab for the management of PN. In addition to this, the study aims to achieve several secondary objectives, including a detailed assessment of the medical history, socio-demographic and disease characteristics of dupilumab-treated PN patients, as well as the evaluation of the long-term real-world effectiveness of dupilumab therapy for PN.
Trial Details
NCT Number NCT05991323
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Prurigo Nodularis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov