This study is not yet accepting patients

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

a study on Telangiectasia

Summary

Eligibility
for people ages 6 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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)

Details

The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.

Keywords

Ataxia Telangiectasia, Ataxia, Telangiectasis, Dexamethasone, Dexamethasone acetate, Dexamethasone 21-phosphate, BB 1101, Dexamethasone sodium phosphate

Eligibility

You can join if…

Open to people ages 6 years and up

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

You CAN'T join if...

  • 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

Locations

  • University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
    Los Angeles California 90095 United States
  • UT Health Houston, Department of pediatrics, division of child & adolescent neurology
    Houston Texas 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Quince Therapeutics S.p.A.
ID
NCT06664853
Phase
Phase 3 Telangiectasia Research Study
Study Type
Interventional
Participants
Expecting 106 study participants
Last Updated