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

NCT05710692 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PRX-102 1 mg/kg every 2 weeks

PRX-102 1 mg/kg every 2 weeks

DRUG

PRX-102 2 mg/kg every 4 weeks

PRX-102 2 mg/kg every 4 weeks

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2027-10-31
Completion
2029-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05710692 on ClinicalTrials.gov