Clinical Trial

A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 years with lucerastat monotherapy in study ID-069A302.
Protocol Amendment History 41 amendments
This ClinicalTrials.gov record has been amended 41 times since 2018-11-07; most recent amendment 2026-06-30.
Status change: Enrolling by Invitation → Active, Not Recruiting 2021-09-28
Status change: Recruiting → Enrolling by Invitation 2021-05-07
Status change: Not Yet Recruiting → Recruiting 2019-01-22
Trial Details
NCT Number NCT03737214
Lead Sponsor Idorsia Pharmaceuticals Ltd.
Conditions Fabry Disease
Enrollment 107 participants
Start Date 2018-12-18
Primary Completion 2029-08 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-02