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.
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Incidence and intensity of treatment-emergent adverse events (TEAEs)
Timeframe: 5 years
Clinically significant changes in urine total glycosaminoglycan (GAG) concentrations throughout the treatment period
Timeframe: 5 years
Incidence and intensity of infusion-related reactions (IRRs)
Timeframe: 5 years