Evaluate the Neurological Effects of EryDex on Subjects With A-T
Completed · Phase 3 · Has a placebo group
Conditions studied: Ataxia Telangiectasia
In brief
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).
Key facts
- Study ID
- NCT06193200
- Run by
- Quince Therapeutics S.p.A.
- People needed
- 105
- Starts
- 2024-06-24
- Expected to finish
- 2025-12-17
- Last updated by the study team
- 2026-04-30
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of A-T
- In autonomous gait or is helped by periodic use of a support
- Genetic confirmation of A-T
- Body weight ≥15 kg
You may not qualify if…
- Participation in another clinical study
- Immune impairment
- History of severe impairment of the immunological system
- Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years
- Severe or unstable pulmonary disease
- Uncontrolled diabetes
- Current chronic or acute significant renal and/or hepatic impairment
- Any previous oral or parenteral steroid use within 6 weeks before Baseline. Treatment with inhaled or intranasal steroids for asthma or allergies, as well as use of topical steroids will be permitted
- A disability that may prevent the subject from completing all study requirements
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.