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

Launched by QUINCE THERAPEUTICS S.P.A. · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Open-Label Extension of the EryDex Study, is looking at the effects of a treatment called EryDex for patients with Ataxia Telangiectasia (A-T), a rare genetic condition that affects movement and coordination. The trial is for individuals who have already participated in a previous study (the NEAT trial) and have completed all necessary assessments. The goal is to see how well EryDex can help manage the neurological symptoms associated with A-T over a longer period.

To be eligible for this trial, participants must weigh at least 15 kg and have successfully completed the IEDAT-04-2022 study. However, certain health conditions may prevent someone from joining, such as significant immune problems or certain types of cancer. If selected, participants can expect to continue receiving EryDex treatment and will be monitored closely by healthcare professionals. This trial is currently recruiting participants of all ages, and it aims to provide valuable information about the long-term effects of EryDex on patients with A-T.

Gender

ALL

Eligibility criteria

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