A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)
Start Date
6/30/2025
Completion Date
6/14/2028
Summary
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease
Detailed Description
Please see NCT #07054515 for information on the AZA-001-301 Master Protocol PRIMARY OBJECTIVE The primary objective of this study is to demonstrate superior efficacy on ataxic manifestations with oral nizubaglustat dosing compared with placebo when administered over 18 months in participants with late-infantile and juvenile forms of NPC disease SECONDARY OBJECTIVES I. To assess additional efficacy in ataxic and non-ataxic manifestations comparing nizubaglustat dosing with placebo when administered over 18 months in participants with late-infantile and juvenile forms of NPC disease II. To assess the pharmacokinetic (PK) properties of nizubaglustat after administration of the first dose (Visit 1) and at steady state after multiple once daily doses III. To assess the pharmacodynamic (PD) effects of nizubaglustat IV. To assess the safety and tolerability of daily oral nizubaglustat dosing compared with placebo, when administered over 18 months in participants with late-infantile and juvenile forms of NPC disease
Eligibility Criteria
Age Range: 4 years to No maximum
Interventions
Nizubaglustat
Placebo
Conditions
Locations
UCSF Children's Hospital and Research Center at Oakland
Oakland, California 94609
United States
University of Minnesota Medical School
Minneapolis, Minnesota 55455
United States
Mayo Clinic Children's Center - PIN
Rochester, Minnesota 55905
United States
Children's Medical Center Dallas
Dallas, Texas 75235
United States
Lysosomal Rare Disorders Research and Treatment Center
Fairfax, Virginia 22030-7404
United States
Hospital de Niños de La Santisima Trinidad
Córdoba, Córdoba Province X5004 ASL
Argentina
Women's and Children's Hospital
North Adelaide, South Australia 5006
Australia
Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria 3052
Australia
Instituto Fernandes Figueira
Rio de Janeiro, Rio de Janeiro 22250-020
Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul 90560-030
Brazil
Hospital Pequeno Principe
Curitiba,
Brazil
M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary
Calgary, Alberta T3B 6A8
Canada
University of Alberta Medical Genetics Clinic
Edmonton, Alberta T6G 2B7
Canada
Centre Hospitalier de l'Universite de Montreal-1000 rue Saint-Denis
Montreal, Quebec H2X 0C1
Canada
SphinCS GmbH
Höchheim, 65239
Germany
Amrita Institute of Medical Sciences and Research Centre
Ernākulam, Kerala 682041
India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi 110029
India
JK Lone Hospital
Jaipur, Rajasthan 302004
India
Christian Medical College and Hospital
Vellore, Tamil Nadu 632004
India
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Italy
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo León 64460
Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20000
Mexico
The Children's Hospital & the University of Child Health Lahore
Lahore, Punjab Province
Pakistan
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto, Porto District 4050-651
Portugal
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Barcelona 8035
Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Madrid 28009
Spain
Inselspital - Universitätsspital Bern
Bern, Canton of Bern 3010
Switzerland
Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi
Adana, Adana 1250
Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi
Çankaya, Ankara 6500
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Bornova, İzmir 35100
Turkey (Türkiye)
Great Ormond Street Hospital
London, London WC1N 3JH
United Kingdom
University College London Hospitals (UCLH)
London, Middlesex WC1N 3BG
United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 9WL
United Kingdom