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)

Trial Profile

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
  • Most Recent Events

    • 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.
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