Clinical Trial Details


Research Study Summary

A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults w/Phenylketonuria


The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in patients equal or greater than 18 years old with hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized study designed to further characterize the safety of BMN 165 during two induction, titration, and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN 165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens. Other key features of this study are the dose regimens chosen for induction and titration; the study duration; self administration of study drug; and the chosen tertiary objectives.

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CW ID: 203165
Date Last Changed: November 6, 2014

Clinical Trial Snapshot

Both Male and Female
18 to 70 Years
Overall Status
Lead Sponsor
BioMarin Pharmaceutical Inc
Facility Type


Laurie Joughin
University of South Florida - Tampa General Hospital Center of Research Excellence
5 Tampa General Circle
Tampa, FL 33606
Phone: (813)844-8153

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