At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
DISC-1459 +2 moredrug
Likely dose
Not stated in 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.
(AURORA) A Randomized, Double-blind, Placebo-Controlled Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and Protoporphyrin IX (PPIX) Concentrations in Participants With Erythropoietic Protoporphyria (EPP)
In Brief
A Phase 2 clinical trial evaluating DISC-1459 and Placebo for Erythropoietic Protoporphyria. Completed, enrolled 75 participants across 9 sites.
Detailed Summary
This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP. Participants may roll over to an open label extension portion after completing the double-blind treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErythropoietic Protoporphyria
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartOct 2022
Primary CompletionFeb 2024
Study CompletionAug 2024
TodayJul 2026
First PostedApr 4, 2022
Enrollment StartOct 31, 2022
Primary CompletionFeb 20, 2024
Study CompletionAug 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.2 years ago
Interventions
DISC-1459drug
Oral dose level 1, once a day for 120 days
DISC-1459drug
Oral dose level 2, once a day for 120 days
Placebodrug
Oral dose, once a day for 120 days