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Withdrawal of Dupilumab in Severe Asthma

Study acronym: WIDUSA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 2, 2025 to Dec 15, 2025 · Eligibility criteria expanded, about 10 words · Secondary endpoints: details revised at 7 of 12 entries · 1 more Show 4 more changesShow less
    • Start date changed from estimate of Apr 2, 2025 to Dec 15, 2025
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 7 of 12 entries
    • Study sites revised (29)
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.
Trial Details
NCT Number NCT06818019
Lead Sponsor University Hospital, Toulouse
Conditions Severe Asthma
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov