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

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Mucopolysaccharidosis II
Interventions
DRUG

tividenofusp alfa

Intravenous repeating dose

Trial Locations (21)

2650

Universitair Ziekenhuis Antwerpen, Edegem

19104

Children's Hospital of Philadelphia, Philadelphia

27599

UNC Children's Research Institute, Chapel Hill

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

77030

The University of Texas Medical School at Houston, Houston

94609

UCSF Benioff Children's Hospital Oakland, Oakland

Unknown

Sanatorio Mater Dei, Buenos Aires

UZ Brussel, Jette

University of Alberta - Faculty of Medicine & Dentistry, Edmonton

Hopital Jeanne De Flandre - Metabolic Diseases Unit, Lille

Universitätsklinikum Hamburg-Eppendorf, Hamburg

SpinCS GmbH, Höchheim

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia, Udine

Hospit U. Vall d'Hebron - PPDS, Barcelona

Drottning Silvias Barn Och Ungdomssjukhus, Gothenburg

University Medical Faculty Balcali Hospital, Adana

Gazi Universitesi Tip Fakultes, Ankara

M5G 1X8

Hospital for Sick Children, Toronto

H4A3J1

McGill University Health Center, Montreal

120 00

Vseobecna Fakultni Nemocnice V Praze, Prague

3015 GD

Erasmus Medical Center - Sophia Children's Hospital, Rotterdam

Sponsors
All Listed Sponsors
lead

Denali Therapeutics Inc.

INDUSTRY