Loading clinical trials...

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05587309•Braintree Laboratories

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years at the time of signing informed consent;
•2. Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
•3. Current evidence of EE of LA grades A to D based on an upper GI endoscopy;
•4. Able to understand and comply with the protocol requirements;
•5. Willing and able to provide written informed consent at Screening;
•6. A female of reproductive potential defined as a non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure; or If a female of childbearing potential, agrees to use an acceptable form of birth control and avoid egg donation from the Screening Visit until 6 months after the last dose of study drug.
•7. If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug.
•8. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.

Exclusion Criteria

•1. Unable to undergo an upper GI endoscopy;
•2. Presence of esophageal stricture, gastroesophageal varix (including post sclerotherapy or ligation), untreated Barrett's esophagus, gastric bleeding, infection, tumor, or gastric or duodenal ulcer on the upper GI endoscopy;
•o Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
•3. Alarm symptoms such as odynophagia, severe dysphagia, upper GI bleeding, weight loss, anemia, or hematochezia within 4 weeks prior to Screening, unless the presumed malignancy is ruled out;
•4. History of eosinophilic esophagitis, achalasia, or other primary esophageal motility disorder; functional heartburn; physiochemical trauma (including radiation, mucosal resection, or cryotherapy); or documented history of delayed gastric emptying;
•5. History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease;
•6. History of acid-suppressive, esophageal, or gastric surgery;
•o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.
•7. History of malignancy within the past 5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin);
•o Note: This is not applicable to patients who had complete response or pathological complete response and whose tumor had not recurred for at least 5 years from the date of last treatment, or patients whose tumor had been removed by endoscopic resection without any findings indicating recurrence of the tumor within 3 years.
+24 more criteria

Locations (122)

Research Site 145

Homewood, Alabama, United States

Research Site 24

Huntsville, Alabama, United States

Research Site 132

Peoria, Arizona, United States

Research Site 150

Peoria, Arizona, United States

Research Site 62

Phoenix, Arizona, United States

Research Site 27

Tucson, Arizona, United States

Research Site 87

Little Rock, Arkansas, United States

Research Site 117

North Little Rock, Arkansas, United States

Research Site 51

Arcadia, California, United States

Research Site 66

Bell Gardens, California, United States

Key Dates

Start Date

October 30, 2022

Primary Completion Date

June 16, 2025

Completion Date

June 16, 2025

Last Updated

September 24, 2025

Enrollment

1,250

ACTUAL participants

Conditions

Erosive Esophagitis

Interventions

BLI5100

DRUG

PPI Control

DRUG

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

NCT01499368

Erosive Esophagitis

View study

COMPLETEDPHASE1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

NCT05050188

Erosive Esophagitis

View study

COMPLETEDPHASE3

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients With Erosive Esophagitis.

Efficacy Study of Ilaprazole to Treat Erosive Esophgitis