drugset / Trial / NCT05587309

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

NCT05587309 ↗

Phase 3 Completed 1250 enrolled Braintree Laboratories
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.

Timeline

Start
2022-10-30
Primary completion
2025-06-16
Completion
2025-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject BLI5100 Unknown — Oral

Indications