A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.

NCT Number	NCT06305234
Lead Sponsor	BioMarin Pharmaceutical
Conditions	Phenylketonuria (PKU)
Enrollment	200 participants
Start Date	2024-01-20
Primary Completion	2033-11-18 (estimated)
Study Completion	2033-11-18 (estimated)
Updated on ClinicalTrials.gov	2026-03-24