CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
DS-1211b +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05569252
NCT05569252Phase 2Completed
CompareCT.gov

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of DS-1211b in Individuals With PseudoXanthoma Elasticum

Daiichi Sankyo·interventional·Posted Oct 6, 2022·Updated Dec 31, 2024

In Brief

A Phase 2 clinical trial evaluating DS-1211b and Placebo for Pseudoxanthoma Elasticum. Completed, enrolled 65 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPseudoxanthoma Elasticum
CountriesNetherlands, United States
CollaboratorsPXE International

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 6, 2022
Enrollment StartOct 20, 2022
Primary CompletionNov 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.7 years ago

Interventions

DS-1211bdrug

DS-1211b tablet administered once daily in the morning either in the fasted state or with a meal

Placeboother

Placebo tablet administered once daily in the morning either in the fasted state or with a meal