A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 30 Jun 2017
At a glance
- Drugs Pegvaliase (Primary)
- Indications Phenylketonuria
- Focus Adverse reactions; Registrational
- Acronyms PRISM-2; Prism302
- Sponsors BioMarin Pharmaceutical
- 30 Jun 2017 According to a BioMarin Pharmaceutical media release, based on the data from this study company has submitted a BLA to the FDA to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.
- 27 Oct 2016 According to a BioMarin media release, the Company plans to submit a BLA to the FDA in the first quarter of 2017 based on the supportive data from this trial.
- 20 Sep 2016 Planned End Date changed from 1 Nov 2016 to 1 Nov 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History