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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. 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),
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02770807
The ClinicalTrials.gov registry entry for NCT02770807 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quince Therapeutics S.p.A., which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which EryDex Low dose DSP is the first listed.
NCT02770807 reports 0 study locations.
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.
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