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NCT06075537

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

Enrolling by Invitation
PHASE2Up to 18InterventionalTreatment
Denali Therapeutics Inc.
~99 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:tividenofusp alfa

At a glance

Recruiting sites
0 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and intensity of treatment-emergent adverse events (TEAEs)
Measured over 5 years
+2 more outcomes measured

Conditions

Mucopolysaccharidosis II

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Neuropathic Mucopolysaccharidosis Type IINon-neuropathic Mucopolysaccharidosis Type II

Where it's being run

29 sites across 23 states
United Kingdom4
Germany2
Italy2
Turkey (Türkiye)2
California1
Illinois1
New Jersey1
North Carolina1

Study leadership

  • Medical Monitor · STUDY_DIRECTOR · Denali Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

For participants from Study DNLI-E-0002 only: Completed at least through the Week 49 visit in Study DNLI-E-0002 and did not discontinue study intervention early
For participants from Study DNLI-E-0007 only: Completed the treatment period of 96 weeks in Cohort A for nMPS II participants and 48 weeks in Cohort B for nnMPS II participants

Exclusion

Unstable or poorly controlled medical condition(s) or significant medical or psychological comorbidity or comorbidities that, in the opinion of the investigator, would interfere with safe participation in the trial or interpretation of study assessments

What this trial measures

  • Incidence and intensity of treatment-emergent adverse events (TEAEs)5 years
  • Clinically significant changes in urine total glycosaminoglycan (GAG) concentrations throughout the treatment period5 years
  • Incidence and intensity of infusion-related reactions (IRRs)5 years

    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.