RecruitingPhase 3NCT07054515

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, GM1 Gangliosidosis or GM2 Gangliosidosis

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 and in Late-infantile and Juvenile-onset Forms of GM1 Gangliosidosis or GM2 Gangliosidosis


Sponsor

Azafaros A.G.

Enrollment

147 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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 and in late-infantile and juvenile-onset forms of GM1 gangliosidosis or GM2 gangliosidosis


Eligibility

Min Age: 4 Years

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Interventions

DRUGAZ-3102

Oral dispersible tablets

DRUGPlacebo

A matching placebo will be administered in the same regimen as the intervention


Locations(37)

UCSF Children's Hospital and Research Center at Oakland

Oakland, California, United States

University of Minnesota Medical School

Minneapolis, Minnesota, United States

Mayo Clinic Childrens Center - PIN

Rochester, Minnesota, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Lysosomal Rare Disorders Research and Treatment Center

Fairfax, Virginia, United States

Hospital Universitario Austral

Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina

Hospital de Niños de La Santisima Trinidad

Córdoba, Córdoba Province, Argentina

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Royal Children's Hospital Melbourne - PIN

Parkville, Victoria, Australia

Instituto Fernandes Figueira

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Pequeno Príncipe

Curitiba, Brazil

M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary

Calgary, Alberta, Canada

University of Alberta Medical Genetics Clinic

Edmonton, Alberta, Canada

Centre Hospitalier de l'Universite de Montreal-1000 rue Saint-Denis

Montreal, Quebec, Canada

AP-HP - Hôpital Armand Trousseau

Paris, France

SphinCS GmbH

Höchheim, Germany

Amrita Institute of Medical Sciences and Research Centre

Ernākulam, Kerala, India

All India Institute of Medical Sciences (AIIMS) - New Delhi

New Delhi, National Capital Territory of Delhi, India

JK Lone Hospital

Jaipur, Rajasthan, India

Christian Medical College and Hospital

Vellore, Tamil Nadu, India

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Nuevo León, Mexico

Centenario Hospital Miguel Hidalgo

Aguascalientes, Mexico

ULS de Santo António, EPE - Centro Materno Infantil Norte

Porto, Porto District, Portugal

ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

Lisbon, Portugal

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Barcelona, Spain

Hospital Infantil Universitario Niño Jesus - PIN

Madrid, Madrid, Spain

Sahlgrenska universitetssjukhuset Östra

Gothenburg, Västra Götaland County, Sweden

Inselspital - Universitätsspital Bern

Bern, Canton of Bern, Switzerland

Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi

Adana, Adana, Turkey (Türkiye)

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi

Çankaya, Ankara, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Bornova, İzmir, Turkey (Türkiye)

Great Ormond Street Hospital

London, London, United Kingdom

University College London Hospitals (UCLH)

London, Middlesex, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

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NCT07054515


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