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Corticosteroid

EryDex for Ataxia Telangiectasia (NEAT Trial)

Phase 3
Recruiting
Research Sponsored by Quince Therapeutics S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to visit 9 (approximately 6 months)
Awards & highlights
Pivotal Trial

Summary

"This trial is being conducted in multiple countries and centers. It is a Phase 3 study that is double-blind and placebo-controlled. The study aims to see how EryDex, which is a

Who is the study for?
This trial is for individuals with a body weight of at least 15 kg who have been clinically diagnosed with Ataxia Telangiectasia (A-T). Participants should be able to walk on their own or occasionally use support and must have genetic confirmation of A-T.
What is being tested?
The study is testing EryDex, which is dexamethasone sodium phosphate inside red blood cells. It's given through an IV once every month. The goal is to see if it helps with neurological symptoms in A-T patients compared to a placebo.
What are the potential side effects?
Possible side effects from the treatment could include those associated with dexamethasone such as increased appetite, mood changes, trouble sleeping, and higher risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to visit 9 (approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to visit 9 (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rescored modified International Cooperative Ataxia Rating Scale (RmICARS)
Secondary study objectives
Clinical Global Impression of Change (CGI-C)
Clinical Global Impression of Severity (CGI-S)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexamethasone sodium phosphateExperimental Treatment1 Intervention
IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using the EryDex System (EDS)
Group II: PlaceboPlacebo Group1 Intervention
IV infusion of placebo encapsulated in autologous erythrocytes using the EryDex System (EDS)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone sodium phosphate
2010
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Quince Therapeutics S.p.A.Lead Sponsor
9 Previous Clinical Trials
583 Total Patients Enrolled
4 Trials studying Ataxia Telangiectasia
449 Patients Enrolled for Ataxia Telangiectasia
BiotrialIndustry Sponsor
11 Previous Clinical Trials
806 Total Patients Enrolled
1 Trials studying Ataxia Telangiectasia
106 Patients Enrolled for Ataxia Telangiectasia
ErydelLead Sponsor
7 Previous Clinical Trials
444 Total Patients Enrolled
3 Trials studying Ataxia Telangiectasia
343 Patients Enrolled for Ataxia Telangiectasia
~65 spots leftby Aug 2025
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