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Evaluate the Neurological Effects of EryDex on Subjects With A-T
Sponsor: Quince Therapeutics S.p.A.
Summary
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate \[DSP\] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangiectasia (A-T).
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex on Subjects With Ataxia Telangiectasia (NEAT)
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2024-06-24
Completion Date
2025-12-17
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone sodium phosphate
Dexamethasone sodium phosphate encapsulated in autologous erythrocytes and administered via IV infusion
Placebo
Placebo encapsulated in autologous erythrocytes and administered via IV infusion
Locations (19)
University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
Los Angeles, California, United States
The Johns Hopkins Hospital, Division of pediatric allergy and immunology
Baltimore, Maryland, United States
Cincinnati Children's Hospital, Division of neurology
Cincinnati, Ohio, United States
UT Health Houston, Department of pediatrics, division of child & adolescent neurology
Houston, Texas, United States
Copenhagen University Hospital, Rigshospitalet, Department of Pediatric Neurology
Copenhagen, Denmark
University Hospital Frankfurt, Pediatric and Adolescent Clinic
Frankfurt, Germany
IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases
Frankfurt, Germany
Spedali Civili di Brescia, Pediatric immunology department
Brescia, Italy
Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health
Roma, Italy
Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening
Oslo, Norway
MedPolonia sp zoo
Poznan, Poland
Instytut "Pomnik-Centrum Zdrowia Dziecka", Immunology clinic
Warsaw, Poland
Hospital Universitari Vall d'Hebron, Department of pediatric neurology
Barcelona, Spain
Hospital Universitario La Paz, Department of pediatric neurology
Madrid, Spain
University Children's Hospital Zürich - Eleonore Foundation
Zurich, Switzerland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
St George's University Hospitals NHS Foundation Trust, Centre for Neonatal and Paediatric Infection
London, United Kingdom
Great Ormond Street Hospital for Children, Zayed Centre for Research
London, United Kingdom
Nottingham Children's Hospital, Queen's Medical Center, Children's neurology
Nottingham, United Kingdom