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NCT05569252 · ClinicalTrials.gov registry record · Phase 2
A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum
A Phase 2 study of Pseudoxanthoma Elasticum, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 7
- Study locations
NCT05569252: Completed Phase 2 study of Pseudoxanthoma Elasticum, sponsored by Daiichi Sankyo.
NCT05569252 is a Phase 2 study of Pseudoxanthoma Elasticum that has completed, run by Daiichi Sankyo. The registered enrollment target is 65 participants, below the 135-participant average among 3 other Pseudoxanthoma Elasticum trials with a reported enrollment target (52% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05569252, a Phase 2 study of Pseudoxanthoma Elasticum, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE). PXE is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and cardiovascular diseases, and adversely impacts the quality of life in afflicted individuals.
Primary Outcome
TEAEs are defined as events that start on or after the first dose of study drug or start prior to but then worsen after the first dose of study drug. Adverse events are coded using MedDRA version 26.1.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG DS-1211b
Study Locations (7)
Massachusetts
- Boston Neuro Research Center - North Dartmouth
- Infinity Medical Research Inc - North Dartmouth
Maryland
- Mid-Atlantic Epilepsy and Sleep Center - Bethesda
New Jersey
- Frontage Clinical Services, Inc. - Secaucus
New York
- Clinilabs - New York
Pennsylvania
- Clinical Research of Philadelphia, LLC - Philadelphia
Other
- UMC Utrecht - Utrecht
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 2 |
What the finished NCT05569252 record still lists
NCT05569252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 135-participant average among 3 other Pseudoxanthoma Elasticum trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Pseudoxanthoma Elasticum appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05569252 lists 7 locations in 6 states (Massachusetts, Maryland, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05569252 about?
NCT05569252 is a clinical study titled "A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum". This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE). PXE is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and car...
What is the current status of trial NCT05569252?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2022-10-20. Estimated completion is 2023-11-21.
What conditions does trial NCT05569252 study?
This clinical trial studies the following conditions: Pseudoxanthoma Elasticum.
What interventions are being tested in trial NCT05569252?
The interventions under investigation include: Placebo (OTHER), DS-1211b (DRUG).
Who is sponsoring clinical trial NCT05569252?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05569252 being conducted?
This trial has 7 study locations across Maryland, Massachusetts, New Jersey, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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