Condition: Mucopolysaccharidosis II · Sponsor: Denali Therapeutics Inc.
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.
This description comes directly from the study's public registry record.
Clinical Trials at Denali Therapeutics · clinical-trials@dnli.com
Always discuss trial participation with your own doctor first.
| UCSF Benioff Children's Hospital Oakland | Oakland, California, United States | Recruiting |
| Ann and Robert H Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| Hackensack University Medical Center | Hackensack, New Jersey, United States | Recruiting |
| UNC Children's Research Institute | Chapel Hill, North Carolina, United States | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
| The University of Texas Medical School at Houston | Houston, Texas, United States | Recruiting |
| University of Utah, PPDS | Salt Lake City, Utah, United States | Recruiting |
| Sanatorio Mater Dei | Buenos Aires, Argentina | Recruiting |
| Women's and Children's Hospital | North Adelaide, Australia | Withdrawn |
| UZ Antwerpen | Antwerp, Antwerpen, Belgium | Recruiting |
| Universitair Ziekenhuis Brussel | Jette, Brussels Capital, Belgium | Recruiting |
+ 20 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05371613