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An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

StatusEnrolling by Invitation
PhasePhase 2/3
Started
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Record History

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  1. Study sites: 27 to 29v25
  2. Study sites: 26 to 27v24
  3. Study sites: 25 to 26v23
  4. Study sites: 24 to 25v22
  5. Study sites: 23 to 24v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 22 to 23v20
  2. Study sites: 21 to 22v19
  3. Study sites: 18 to 21v18
  4. Study sites: 17 to 18v17
  5. Study sites: 16 to 17v16
  6. Study sites: 14 to 16v15
  7. Study sites: 13 to 14v14
  8. Study sites: 12 to 13v13
  9. Study sites: 11 to 12v12
  10. Study sites: 10 to 11v11
  11. Study sites: 9 to 10v10
  12. Study sites: 6 to 9v9
  13. Site details revised at 3 of 6 sitesv8
  14. Re-verified, no change to tracked fieldsv7
  15. Study sites: 3 to 6v6
  16. Study sites: 2 to 3v5
  17. Study sites: 1 to 2v4
  18. Interventions: DNL310 (Drug) to tividenofusp alfa (Drug)
    • Study title expanded, about 2 words
    v3
  19. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous (IV) enzyme replacement therapy (ERT) for Hunter syndrome (MPS II). Participants who complete at least through the Week 49 visit in Study DNLI-E-0002 and do not discontinue study intervention early and participants who complete Study DNLI-E-0007 will be enrolled in this OLE. All participants will receive DNL310 for up to 5 years from the time of entry in this OLE. Participants, site staff, and the Sponsor will remain blinded to the original treatment assignment for participants entering this OLE from Study DNLI-E-0007.
Trial Details
NCT Number NCT06075537
Lead Sponsor Denali Therapeutics Inc.
Conditions
(from sponsor)		 Mucopolysaccharidosis II
Related terms Mucopolysaccharidosis II, Sudden Infant Death
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov