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

Description

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).

Conditions

Ataxia Telangiectasia

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Study Overview

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Study Details

Study overview

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).

An Open-Label Extension Study of EryDex in Patients With Ataxia Telangiectasia Following Participation in Study IEDAT-04-2022 (NEAT)

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

Condition
Ataxia Telangiectasia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence, Los Angeles, California, United States, 90095

Baltimore

The Johns Hopkins Hospital, Division of pediatric allergy and immunology, Baltimore, Maryland, United States, 21289

Cincinnati

Cincinnati Children's Hospital, Division of neurology, Cincinnati, Ohio, United States, 45229

Houston

UT Health Houston, Department of pediatrics, division of child & adolescent neurology, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * body weight ≥15 kg
  • * participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
  • * 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

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Quince Therapeutics S.p.A.,

Dirk Thye, MD, STUDY_DIRECTOR, Quince Therapeutics S.p.A.

Study Record Dates

2026-11-30