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

NCT06664853 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-05-05

Study results available
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Summary

This is an international, multi-center, prospective, open-label, non-comparative study aiming to provide access to treatment with EryDex to ataxia telangiectasia (A-T) patients who completed the IEDAT-04-2022 trial which studied the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

Conditions

  • Ataxia Telangiectasia

Interventions

DRUG

Dexamethasone sodium phosphate

Dexamethasone Sodium Phosphate encapsulated in autologous erythrocytes and administered via intravenous (IV) infusion

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • Quince Therapeutics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dirk Thye, MD · Quince Therapeutics S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Italy
  • Norway
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664853 on ClinicalTrials.gov