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A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18

Study acronym: ROSSELLA
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Apr 2027 to Jul 2027v23
  2. Study sites: 16 to 14v22
  3. Re-verified, no change to tracked fieldsv21
  4. Study sites: 17 to 16v20
  5. Study sites: 14 to 17v19
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 1 of 14 sitesv18
  2. Study sites: 16 to 14v17
  3. Re-verified, no change to tracked fieldsv16
  4. Study sites: 14 to 16v15
  5. Study sites: 12 to 14v14
  6. Study sites: 11 to 12v13
  7. Study sites: 4 to 11v12
  8. Study sites: 3 to 4v11
  9. Study sites: 2 to 3v10
  10. Study sites: 1 to 2
    • Start date changed from estimate of Jun 2023 to Jul 18, 2023
    • Eligibility criteria expanded, about 20 words
    v9
  11. Start date: Apr 2023 to Jun 2023v8
  12. Primary and study completion dates: Feb 2025 to Apr 2027
    • Start date: Dec 2022 to Apr 2023
    • Eligibility criteria expanded, about 63 words
    v7
  13. Enrollment target: 22 to 36v6 Show 6 more changesShow less
    • Start date: Aug 2022 to Dec 2022
    • Primary endpoints: 2 to 1
    • Interventions: Cipaglucosidase alfa (ATB200) (Biological), Miglustat (AT2221) (Drug) to Cipaglucosidase alfa (Biological), Miglustat (Drug)
    • Eligibility criteria expanded, about 74 words
    • Study arms: 3 to 2
    • Study title shortened, about 1 word
  14. Start date: Dec 2021 to Aug 2022v5
  15. Start date: Aug 2021 to Dec 2021v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 3 words
    v3
  17. Study title revisedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.
Trial Details
NCT Number NCT04808505
Lead Sponsor Amicus Therapeutics
Conditions
(from sponsor)		 Glycogen Storage Disease Type II Infantile Onset
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov