Clinical Trial

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Study acronym: COMPASS
Recruiting Phase 2/3
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Summary
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.
Protocol Amendment History 47 amendments
This ClinicalTrials.gov record has been amended 47 times since 2022-05-09; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2022-06-17
Trial Details
NCT Number NCT05371613
Lead Sponsor Denali Therapeutics Inc.
Conditions Mucopolysaccharidosis II
Enrollment 63 participants
Start Date 2022-07-21
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-05