drugset / Trial / NCT05308472

Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP

NCT05308472

Phase 2 Completed 75 enrolled Disc Medicine, Inc
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-10-31
Primary completion
2024-02-20
Completion
2024-08-23

Drugs

EvaluationDrugModalityDoseRoute
Subject bitopertin Small molecule Oral