Status:
ACTIVE_NOT_RECRUITING
Evaluate the Neurological Effects of EryDex on Subjects With A-T
Lead Sponsor:
Quince Therapeutics S.p.A.
Collaborating Sponsors:
Biotrial
Conditions:
Ataxia Telangiectasia
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
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 aut...
Detailed Description
The EryDex System (EDS) is a combination product that is used to load dexamethasone sodium phosphate (DSP) into autologous erythrocytes (EryDex) which is infused into the patient. In the placebo arm,...
Eligibility Criteria
Inclusion
- Clinical diagnosis of A-T
- In autonomous gait or is helped by periodic use of a support
- Genetic confirmation of A-T
- Body weight ≥15 kg
Exclusion
- Participation in another clinical study
- Immune impairment
- History of severe impairment of the immunological system
- Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years
- Severe or unstable pulmonary disease
- Uncontrolled diabetes
- Current chronic or acute significant renal and/or hepatic impairment
- 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
- A disability that may prevent the subject from completing all study requirements
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06193200
Start Date
June 24 2024
End Date
December 1 2025
Last Update
October 2 2025
Active Locations (19)
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1
University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
Los Angeles, California, United States, 90095
2
The Johns Hopkins Hospital, Division of pediatric allergy and immunology
Baltimore, Maryland, United States, 21289
3
Cincinnati Children's Hospital, Division of neurology
Cincinnati, Ohio, United States, 45229
4
UT Health Houston, Department of pediatrics, division of child & adolescent neurology
Houston, Texas, United States, 77030