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)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

July 21, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Mucopolysaccharidosis II
Interventions
DRUG

tividenofusp alfa

Intravenous repeating dose

DRUG

idursulfase

Intravenous repeating dose

Trial Locations (32)

1090

RECRUITING

Universitair Ziekenhuis Brussel, Jette

1330

RECRUITING

Cukurova University Medical Faculty Balcali Hospital, Adana

2650

RECRUITING

UZ Antwerpen, Antwerp

3000

RECRUITING

Erasmus Medical Center - Sophia Children's Hospital, Rotterdam

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

27514

RECRUITING

UNC Children's Research Institute, Chapel Hill

28009

RECRUITING

Hospital Infantil Universitario Niño Jesus, Madrid

33100

RECRUITING

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

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

59000

RECRUITING

Hôpital Jeanne de Flandre, Lille

60611

RECRUITING

Ann and Robert H Lurie Children's Hospital of Chicago, Chicago

65239

RECRUITING

SphinCS, Höchheim

77030

RECRUITING

The University of Texas Medical School at Houston, Houston

84132

RECRUITING

University of Utah, PPDS, Salt Lake City

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

07601

RECRUITING

Hackensack University Medical Center, Hackensack

Unknown

RECRUITING

Sanatorio Mater Dei, Buenos Aires

WITHDRAWN

Women's and Children's Hospital, North Adelaide

RECRUITING

Hospital de Clínicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

WITHDRAWN

Instituto Fernandes Figueira, Rio de Janeiro

RECRUITING

University of Alberta - Faculty of Medicine & Dentistry, Edmonton

RECRUITING

Medizinische Universität Lausitz - Carl Thiem, Cottbus

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

M5G1X8

RECRUITING

Hospital for Sick Children, Toronto

H4A3J1

RECRUITING

McGill University Health Center, Montreal

128 08

RECRUITING

Vseobecna Fakultni Nemocnice V Praze, Prague

08035

RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

416 85

RECRUITING

Drottning Silvias Barn Och Ungdomssjukhus, Gothenburg

06500

RECRUITING

Gazi Universitesi Tip Fakultesi, Çankaya

WC1N 3JH

RECRUITING

Great Ormond Street Hospital for Children, London

NW3 2QG

RECRUITING

Royal Free Hospital, London

M6 8HD

RECRUITING

Salford Royal Hospital, Salford

Sponsors
All Listed Sponsors
lead

Denali Therapeutics Inc.

INDUSTRY