drugset / Trial / NCT05308472
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bitopertin | Small molecule | — | Oral |