NCT06075537Phase 2, phase 3Enrolling by invitation

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

Study sponsor: Denali Therapeutics Inc. · DNLI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-06Estimated

Enrollment · participants99Estimated

Source updated2026-06-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Mucopolysaccharidosis II

Treatments or interventions studied

tividenofusp alfaDrug

Primary outcomes · main study measures

Read the study measures

measure: Incidence and intensity of treatment-emergent adverse events (TEAEs); timeFrame: 5 years; measure: Clinically significant changes in urine total glycosaminoglycan (GAG) concentrations throughout the treatment period; timeFrame: 5 years; measure: Incidence and intensity of infusion-related reactions (IRRs); description: The intensity of IRRs will be assessed following each infusion of DNL310 using the categories of Mild, Moderate and Severe. IRRs will be summarized overall as well as stratified by intensity.; timeFrame: 5 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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