Back to Trials
NCT07082725PHASE3Recruiting

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)

Azafaros B.V.

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

Inclusion Criteria: * Signed informed consent * Confirmed diagnosis of NPC disease * Patient is unable or unwilling to take miglustat, or is, in the opinion of the investigator, unsatisfactorily treated with miglustat * Male and female participants aged 4 years and older at the time of informed consent * Onset of neurological symptoms from 2 to 15 years * Disability level at Baseline: Ataxic disturbances with a total SARA score of ≥3 and ≤30 at Baseline * Female of childbearing potential who are sexually active willing to follow the contraceptive guidance * Male participants with a female partner of childbearing potential willing to follow the contraceptive guidance Exclusion Criteria: * A history of medical conditions other than NPC disease that, in the opinion of the Principal Investigator, would confound scientific rigor or the interpretation of results * Body weight of \<10 kg * The presence of another neurologic disease * The presence of moderate or severe hepatic impairment * The presence of moderate or severe renal impairment * Platelet count of \<100x10\^9/L * The dose of any anti-epileptic treatment(s) was not stable (required a change in dose within the previous 3 months) and/or a new anti-epileptic treatment (drug or procedure) was prescribed in the month before Baseline * Prior use of an investigational drug within the 3 months before Screening; or prior participation in a clinical study involving gene therapy or stem cell transplantation within 2 years prior to Screening * A positive serum pregnancy test (for women of childbearing potential) * Current treatment with miglustat, provided the patient has been using the recommended dose for most of the past 12 months AND is, in the opinion of the investigator, satisfactorily treated with miglustat. Any participants receiving miglustat are required to undergo a 1-month washout period before starting study medication

Interventions

DRUG

Nizubaglustat

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Niemann-Pick Type C Disease

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