MedTrace Logo

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

NCT05587309 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2025-09-24

No results posted yet for this study

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

DRUG

BLI5100

Orally via tablet

DRUG

PPI Control

Orally via tablet

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • Leah Hollins · Braintree Laboratories / Sebela Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2025-06-16
Completion
2025-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587309 on ClinicalTrials.gov