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A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

Study acronym: FOSteR
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 71% 580 → 170 participants
See other at-risk trials from Chiesi Farmaceutici S.p.A.

Record History

  1. Enrollment reduced: 580 → 170 participants Sponsor changed: Amryt Pharma to Chiesi Farmaceutici S.p.A. · Trial sites expanded: 5 → 12 locations · Secondary endpoints: details revised at 1 of 1 entry · 3 more Show 6 more changesShow less
    • Sponsor changed: Amryt Pharma to Chiesi Farmaceutici S.p.A.
    • Trial sites expanded: 5 → 12 locations
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
    • Study description shortened, about 5 words
    • Collaborators shortened, about 3 words
  2. Study sites: 1 to 5v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 30, 2024 to Dec 18, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 30, 2024 to Dec 18, 2024
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for a minimum of 3 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.
Trial Details
NCT Number NCT06423573
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov