RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-12-11
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06664853

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.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * body weight ≥15 kg
  2. * participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
  1. * safety contraindications for continuation of treatment, as determined by the investigator
  2. * clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
  3. * Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
  4. * requiring treatment with a systemic corticosteroid

Contacts and Locations

Study Contact

Dirk Thye, MD
CONTACT
415-533-3236
clinops@quincetx.com
Pamela Raggi, M.Sc
CONTACT
00 39 3473962536
clinops@quincetx.com

Principal Investigator

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

Study Locations (Sites)

University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
Los Angeles, California, 90095
United States
The Johns Hopkins Hospital, Division of pediatric allergy and immunology
Baltimore, Maryland, 21289
United States
Cincinnati Children's Hospital, Division of neurology
Cincinnati, Ohio, 45229
United States
UT Health Houston, Department of pediatrics, division of child & adolescent neurology
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Quince Therapeutics S.p.A.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Ataxia Telangiectasia