Clinical Trial

Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease

Study acronym: RISE
Recruiting Phase 2/3
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Summary
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned of a total of approximately 16 male and female Fabry disease patients between the ages of 13 and 70 years to be part of the study. The study is conducted in Japan.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-01-24; most recent amendment 2026-03-16.
Status change: Not Yet Recruiting → Recruiting 2023-08-09
Trial Details
NCT Number NCT05710692
Lead Sponsor Chiesi Farmaceutici S.p.A.
Collaborators: ICON plc
Conditions Fabry Disease
Enrollment 16 participants
Start Date 2023-08-01
Primary Completion 2027-10 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-18