Open-Label Extension of EryDex Study IEDAT-04-2022
Stopped early · Phase 3
Conditions studied: Ataxia Telangiectasia
In brief
This is an international, multi-center, prospective, open-label, non-comparative study aiming to provide access to treatment with EryDex to ataxia telangiectasia (A-T) patients who completed the IEDAT-04-2022 trial which studied the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Key facts
- Study ID
- NCT06664853
- Run by
- Quince Therapeutics S.p.A.
- People needed
- 101
- Starts
- 2024-12-11
- Expected to finish
- 2026-01-30
- Last updated by the study team
- 2026-05-05
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- body weight ≥15 kg
- participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
You may not qualify if…
- safety contraindications for continuation of treatment, as determined by the investigator
- clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
- Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
- requiring treatment with a systemic corticosteroid
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
- Saint Peter's University Hospital, Inc. — New Brunswick, New Jersey, 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, Denmark
- University Hospital Frankfurt, Pediatric and Adolescent Clinic — Frankfurt, Germany, Germany
- IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases — Frankfurt am Main, Hesse, Germany
- Spedali Civili di Brescia, Pediatric immunology department — Brescia, Italy, Italy
- Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health — Roma, Italy, Italy
- Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening — Oslo, Norway, 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, Spain
- Hospital Universitario La Paz, Department of pediatric neurology — Madrid, Spain, Spain
- Universitary Hospital Virgen del Rocío — Seville, Spain
- University Children's Hospital Zürich - Eleonore Foundation — Zurich, Switzerland
- Great Ormond Street Hospital for Children, Zayed Centre for Research — London, United Kingdom, United Kingdom
- Nottingham Children's Hospital, Queen's Medical Center, Children's neurology — Nottingham, United Kingdom, United Kingdom
- 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
Full record on ClinicalTrials.gov
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