drugset
drugset / Trial / NCT05883748

HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP

NCT05883748 ↗

Phase 2/3 Enrolling by invitation 230 enrolled Disc Medicine, Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.

Timeline

Start
2023-08-31
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject bitopertin Small molecule — Oral

Indications

erythropoietic protoporphyria