At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 215 enrolled
Drug / intervention
BMN165 20mg/day +2 moredrug
Likely dose
BMN165 20mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating BMN165 20mg/day, BMN165 40mg/day, and 1 other intervention for Phenylketonuria (PKU). Completed, enrolled 215 participants across 29 sites.
Detailed Summary
The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria (PKU)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartJul 2013
Primary CompletionJan 2016
Study CompletionFeb 2019
TodayJul 2026
First PostedJul 1, 2013
Enrollment StartJul 29, 2013
Primary CompletionJan 13, 2016
Study CompletionFeb 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.0 years ago
Interventions
BMN165 20mg/daydrug
BMN165 20mg/day self-administered daily
BMN165 40mg/daydrug
BMN165 40mg/day self-administered daily
Placebodrug
Non-drug placebo, self-administered daily