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
← catalyst calendarNCT06075537 · readout ≤ 315 d
Sponsored by Denali Therapeutics Inc. (industry) · DNLI — their whole pipeline →.
Phase
Phase 2/3
Status
Enrolling by invitation
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
99estimated
Sites
29
Countries
Argentina, Belgium, Canada +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-09-20 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mucopolysaccharidosis II
Intervention
- Drug: tividenofusp alfa
Primary outcomes
what the primary-completion date above is the date OFIncidence and intensity of treatment-emergent adverse events (TEAEs)
measured 5 years
Clinically significant changes in urine total glycosaminoglycan (GAG) concentrations throughout the treatment period
measured 5 years
Incidence and intensity of infusion-related reactions (IRRs)
measured 5 years
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