Clinical Trial

Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

Name: Immune Modulation During Palynziq® Treatment in Adults (IMPALA) — clinical trial record (NCT07477691)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 4

View on ClinicalTrials.gov →

Summary

Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.

Protocol Amendment History 1 change

critical Recruitment opened 2026-06-18

Trial Details

NCT Number	NCT07477691
Lead Sponsor	BioMarin Pharmaceutical
Conditions	Phenylketonuria
Enrollment	12 participants
Start Date	2026-05-29
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-17