drugset
drugset / Trial / NCT07477691

Immune Modulation During Palynziq® Treatment in Adults (IMPALA)

NCT07477691 ↗

Phase 4 Recruiting 12 enrolled BioMarin Pharmaceutical
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-29
Primary completion
2027-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 15 mg Oral
Background Pegvaliase Protein / enzyme biologic — Subcutaneous

Indications

phenylketonuria