COMPLETED

Evaluate the Neurological Effects of EryDex on Subjects With A-T

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, 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).

Official Title

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex on Subjects With Ataxia Telangiectasia (NEAT)

Quick Facts

Study Start:2024-06-24
Study Completion:2025-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06193200

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. * Clinical diagnosis of A-T
  2. * In autonomous gait or is helped by periodic use of a support
  3. * Genetic confirmation of A-T
  4. * Body weight ≥15 kg
  1. * Participation in another clinical study
  2. * Immune impairment
  3. * History of severe impairment of the immunological system
  4. * Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years
  5. * Severe or unstable pulmonary disease
  6. * Uncontrolled diabetes
  7. * Current chronic or acute significant renal and/or hepatic impairment
  8. * 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
  9. * A disability that may prevent the subject from completing all study requirements

Contacts and Locations

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 Date2024-06-24
Study Completion Date2025-12-17

Study Record Updates

Study Start Date2024-06-24
Study Completion Date2025-12-17

Terms related to this study

Keywords Provided by Researchers

  • Ataxia Telangiectasia
  • A-T
  • Louis-Bar syndrome
  • Cerebello-oculocutaneous telangiectasia

Additional Relevant MeSH Terms

  • Ataxia Telangiectasia