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

NCT06193200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-04-30

Study results available
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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 autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangiectasia (A-T).

Conditions

  • Ataxia Telangiectasia

Interventions

DRUG

Dexamethasone sodium phosphate

Dexamethasone sodium phosphate encapsulated in autologous erythrocytes and administered via IV infusion

OTHER

Placebo

Placebo encapsulated in autologous erythrocytes and administered via 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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-12-17
Completion
2025-12-17
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 NCT06193200 on ClinicalTrials.gov