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

Launched by QUINCE THERAPEUTICS S.P.A. · Dec 21, 2023

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ClinConnect Summary

This clinical trial is looking at how a treatment called EryDex may help improve neurological symptoms in patients with Ataxia Telangiectasia (A-T), a condition that affects movement and coordination. EryDex is given through an intravenous (IV) infusion once every 28 days. The study is being conducted at multiple locations around the world and is designed to compare the effects of EryDex with a placebo (which looks like the treatment but has no active ingredients) to see if it truly makes a difference for patients.

To be eligible for the trial, participants must have a clinical diagnosis of A-T and be able to walk independently or with some assistance. They also need to be confirmed genetically as having A-T and weigh at least 15 kg. However, people with certain health issues, like severe lung disease or uncontrolled diabetes, or those who have used other steroid treatments recently, may not be able to join. If you or a loved one qualify and choose to participate, you can expect close monitoring throughout the study to evaluate how EryDex affects your symptoms. This trial is an important step towards finding new ways to manage A-T and improve quality of life for those affected.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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