NCT05587309

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

A Phase 3, Double-Blind, Randomized, Two-Phase, Active-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: Braintree Laboratories · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	BLI5100	Orally via tablet
DRUG	PPI Control	Orally via tablet

Timeline

• Start date: 2022-10-30
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2022-10-20
• Last updated: 2025-09-24

Locations

122 sites across 1 country: United States

Regulatory

• FDA-regulated drug study