Open-Label Extension of EryDex Study IEDAT-04-2022

Last updated: October 31, 2025
Sponsor: Quince Therapeutics S.p.A.
Overall Status: Active - Recruiting

Phase

3

Condition

Friedreich's Ataxia

Dyskinesias

Treatment

Dexamethasone sodium phosphate

Clinical Study ID

NCT06664853
IEDAT-05-2024
  • Ages > 6
  • All Genders

Study Summary

This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • body weight ≥15 kg

  • participation in IEDAT-04-2022 study and its completion, including final efficacyand safety assessments

Exclusion

Exclusion Criteria:

  • safety contraindications for continuation of treatment, as determined by theinvestigator

  • 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 atleast 2 years.

  • requiring treatment with a systemic corticosteroid

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Dexamethasone sodium phosphate
Phase: 3
Study Start date:
December 11, 2024
Estimated Completion Date:
November 30, 2026

Study Description

The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet, Department of Pediatric Neurology

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet, Department of Pediatric Neurology

    Copenhagen 2618425, 2100
    Denmark

    Site Not Available

  • Tübingen University Hospital, Division Translational Genomics of Neurodegenerative Diseases

    Tübingen, Bade-Würtenberg 72076
    Germany

    Site Not Available

  • IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases

    Frankfurt, Hesse 60596
    Germany

    Site Not Available

  • IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases

    Frankfurt am Main 2925533, Hesse 2905330 60596
    Germany

    Active - Recruiting

  • University Hospital Frankfurt, Pediatric and Adolescent Clinic

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • University Hospital Frankfurt, Pediatric and Adolescent Clinic

    Frankfurt 2925536, 60590
    Germany

    Active - Recruiting

  • Spedali Civili di Brescia, Pediatric immunology department

    Brescia, 25213
    Italy

    Site Not Available

  • Spedali Civili di Brescia, Pediatric immunology department

    Brescia 3181554, 25213
    Italy

    Site Not Available

  • Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health

    Roma, 00161
    Italy

    Site Not Available

  • Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health

    Roma 8957247, 00161
    Italy

    Active - Recruiting

  • Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening

    Oslo, 0372
    Norway

    Site Not Available

  • Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening

    Oslo 3143244, 0372
    Norway

    Site Not Available

  • MedPolonia sp zoo

    Poznan 3088171, 60-693
    Poland

    Active - Recruiting

  • MedPolonia sp zoo

    Poznań, 60-693
    Poland

    Site Not Available

  • Instytut "Pomnik-Centrum Zdrowia Dziecka", Immunology clinic

    Warsaw, 04-736
    Poland

    Site Not Available

  • Instytut "Pomnik-Centrum Zdrowia Dziecka", Immunology clinic

    Warsaw 756135, 04-736
    Poland

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron, Department of pediatric neurology

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron, Department of pediatric neurology

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz, Department of pediatric neurology

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario La Paz, Department of pediatric neurology

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • University Children's Hospital Zürich - Eleonore Foundation

    Zurich 2657896, CH 8008
    Switzerland

    Active - Recruiting

  • University Children's Hospital Zürich - Eleonore Foundation

    Zürich, CH 8008
    Switzerland

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B152GW
    United Kingdom

    Site Not Available

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham 2655603, B152GW
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children, Zayed Centre for Research

    London, WC1N 1DZ
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust, Centre for Neonatal and Paediatric Infection

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Great Ormond Street Hospital for Children, Zayed Centre for Research

    London 2643743, WC1N 1DZ
    United Kingdom

    Site Not Available

  • St George's University Hospitals NHS Foundation Trust, Centre for Neonatal and Paediatric Infection

    London 2643743, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Nottingham Children's Hospital, Queen's Medical Center, Children's neurology

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Nottingham Children's Hospital, Queen's Medical Center, Children's neurology

    Nottingham 2641170, NG7 2UH
    United Kingdom

    Site Not Available

  • University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • The Johns Hopkins Hospital, Division of pediatric allergy and immunology

    Baltimore, Maryland 21289
    United States

    Site Not Available

  • The Johns Hopkins Hospital, Division of pediatric allergy and immunology

    Baltimore 4347778, Maryland 4361885 21289
    United States

    Active - Recruiting

  • Biotrial Inc.

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Biotrial Inc.

    Newark 5101798, New Jersey 5101760 07103
    United States

    Site Not Available

  • Cincinnati Children's Hospital, Division of neurology

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Children's Hospital, Division of neurology

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Terminated

  • UT Health Houston, Department of pediatrics, division of child & adolescent neurology

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Health Houston, Department of pediatrics, division of child & adolescent neurology

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.