MedTrace Logo

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

NCT03737214 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-10-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lucerastat

Administered in hard gelatin capsules containing 250 mg of lucerastat.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2029-08-31
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03737214 on ClinicalTrials.gov