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NCT03563053 · ClinicalTrials.gov registry record · Phase 3
Extension Treatment Using EryDex System in Patients With AT Who Participated in the ATTeST-IEDAT-02-2015 Study
A Phase 3 study, sponsored by Quince Therapeutics S.p.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT03563053: Clinical Trial Phase 3 study, sponsored by Quince Therapeutics S.p.A..
NCT03563053 is a Phase 3 study that was terminated before completion, run by Quince Therapeutics S.p.A.. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03563053, a Phase 3 study, was terminated before completion, sponsored by Quince Therapeutics S.p.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
Primary Objective To monitor and evaluate the long-term safety and tolerability of EDS-EP in AT patients. Secondary Objective To evaluate the long-term effect of EDS-EP on health-related Quality of Life (QoL; EQ-5D-5L scale). Exploratory Objective: To evaluate the long-term effect of EDS-EP in treating central nervous system (CNS) symptoms, as measured by the "Modified" International Cooperative Ataxia Rating Scale (mICARS), and Clinical Global Impression of severity and change (CGI-S/C).
Primary Outcome
Assessment of TEAEs, treatment-emergent serious adverse events (TESAE), and adverse events of special interest (AESI) were performed throughout the study, from the time of signing of the ICF at Baseline Visit through to the Final Study Visit (Month 12 or early discontinuation). All patients were to be followed up through 30 days after the Final Visit (Month 12 or early discontinuation) or at least 60 days after the final infusion, whichever was longer.
Interventions
- COMBINATION_PRODUCT EryDex System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2022-09-02 |
| Phase | Phase 3 |
Why NCT03563053 stopped before completion
NCT03563053 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which EryDex System is the first listed.
NCT03563053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03563053 about?
NCT03563053 is a clinical study titled "Extension Treatment Using EryDex System in Patients With AT Who Participated in the ATTeST-IEDAT-02-2015 Study". Primary Objective To monitor and evaluate the long-term safety and tolerability of EDS-EP in AT patients. Secondary Objective To evaluate the long-term effect of EDS-EP on health-related Quality of Life (QoL; EQ-5D-5L scale). Exploratory Objective: To evaluate the long-term effect of EDS-EP in ...
What is the current status of trial NCT03563053?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2018-06-12. Estimated completion is 2022-09-02.
What interventions are being tested in trial NCT03563053?
The interventions under investigation include: EryDex System (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03563053?
This trial is sponsored by Quince Therapeutics S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03563053's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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