Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02770807 · ClinicalTrials.gov registry record · Phase 3
Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients
A Phase 3 study, sponsored by Quince Therapeutics S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
NCT02770807: Completed Phase 3 study, sponsored by Quince Therapeutics S.p.A..
NCT02770807 is a Phase 3 study that has completed, run by Quince Therapeutics S.p.A.. The registered enrollment target is 176 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02770807, a Phase 3 study, has completed, sponsored by Quince Therapeutics S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
Study Summary
Objectives: The objective of study was to evaluate the safety and the efficacy of EryDex (Dexamethasone sodium phosphate encapsulated in autologous erythrocytes, using the EryDex System - EDS) at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on Neurological Symptoms in Patients With Ataxia Telangiectasia. Initial Double-Blind Treatment Period (0 to 6 Months) Primary Efficacy Objective: • Evaluate the effect of EryDex at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on central nervous system (CNS) symptoms measured by the change in the Modified International Cooperative Ataxia Rating Scale (mICARS) from baseline to Month 6 (Visit 9) in patients with ataxia telangiectasia (A-T). Secondary Efficacy Objectives: * Evaluate the effect of EryDex, compared to placebo, on the Clinical Global Impression of Change (CGI-C) in patients with A-T from baseline to Month 6 (Visit 9). * Evaluate the effect of EryDex, compared to placebo, on measures of Clinical Global Impression of Severity (CGI-S; structured) in patients with A-T from baseline to Month 6 (Visit 9) * Evaluate the effect of EryDex, compared to placebo, on measures of Adaptive behavior measures in patients with A-T by the Vineland Adaptive Behavior Scales (VABS) from baseline to Month 6 (Visit 9). Safety Objectives: • Evaluate the safety and tolerability of two non-overlapping doses of EryDex, compared to placebo, in patients with A-T over the 12-month double-blind study duration. Extension Treatment Period (6-12 Months): Primary Objective: • Evaluate the efficacy of EryDex at two dose levels (low dose and high dose DSP/infusion) compared to placebo, in treating CNS symptoms in A-T patients during longer-term treatment (up to 12 months), as measured by the mICARS. Secondary Objectives: * Evaluate the longer-term (up to 12 months) safety and tolerability of EryDex in A-T patients. * Compare the effects of EryDex on the CGI-C and CGI-S (structured),
Primary Outcome
The International Cooperative Ataxia Rating Scale (ICARS) was an assessment of the degree of impairment in patients with cerebellar ataxia and was administered in its entirety; however, the primary efficacy assessment was based on the modified (m)ICARS, which excluded the Oculomotor domain (items 17 to 19) and items 8 to 12 of the Kinetic Functions domain of the ICARS. The mICARS was a 54 points maximum score (min 0) questionnaire divided into 3 sections: * Posture and Gait Disturbance section
Interventions
- DRUG EryDex Low dose DSP
- DRUG EryDex High dose DSP
- DRUG Pooled Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 3 |
What the finished NCT02770807 record still lists
NCT02770807 is an interventional study that assigns participants to a tested intervention. The registered 176 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 (77% lower).
The record links to 0 conditions, and to 3 interventions - of which EryDex Low dose DSP is the first listed.
NCT02770807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02770807 about?
NCT02770807 is a clinical study titled "Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients". Objectives: The objective of study was to evaluate the safety and the efficacy of EryDex (Dexamethasone sodium phosphate encapsulated in autologous erythrocytes, using the EryDex System - EDS) at two dose levels (low dose and high dose DSP/infusion), compared to placebo, on Neurological Symptoms in...
What is the current status of trial NCT02770807?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2017-03-02. Estimated completion is 2021-05-13.
What interventions are being tested in trial NCT02770807?
The interventions under investigation include: EryDex Low dose DSP (DRUG), EryDex High dose DSP (DRUG), Pooled Placebo (DRUG).
Who is sponsoring clinical trial NCT02770807?
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 NCT02770807's enrollment target sits among peer trials
176 1438th of 2000 higher than 561 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03304821 · 176 participants · Phase 2
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
- NCT03447938 · 176 participants · NA
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
- NCT03824145 · 176 participants · NA
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
- NCT04177914 · 176 participants · Phase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI