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

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.

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: BLI5100; Drug: PPI Control

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Research Site 145
    • Huntsville, Alabama, United States, 35801
      • Research Site 24
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Research Site 132
    • Peoria, Arizona, United States, 85381
      • Research Site 150
    • Phoenix, Arizona, United States, 85018
      • Research Site 62
    • Tucson, Arizona, United States, 85712
      • Research Site 27
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Research Site 87
    • North Little Rock, Arkansas, United States, 72117
      • Research Site 117
  • California
    • Arcadia, California, United States, 91006
      • Research Site 51
    • Bell Gardens, California, United States, 90201
      • Research Site 66
    • Camarillo, California, United States, 93012
      • Research Site 156
    • Canoga Park, California, United States, 91304
      • Research Site 19
    • Chula Vista, California, United States, 91910
      • Research Site 94
    • Huntington Park, California, United States, 90255
      • Research Site 10
    • La Mesa, California, United States, 91942
      • Research Site 55
    • Los Angeles, California, United States, 90017
      • Research Site 72
    • San Diego, California, United States, 92120
      • Research Site 14
    • Santa Ana, California, United States, 92704
      • Research Site 13
    • Santa Ana, California, United States, 92703
      • Research Site 85
    • Santa Maria, California, United States, 93458
      • Research Site 41
    • Westlake, California, United States, 90057
      • Research Site 54
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Research Site 89
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Research Site 147
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Research Site 74
    • Cooper City, Florida, United States, 33024
      • Research Site 108
    • Doral, Florida, United States, 33172
      • Research Site 91
    • Hialeah, Florida, United States, 33013
      • Research Site 03
    • Homestead, Florida, United States, 33030
      • Research Site 78
    • Lake City, Florida, United States, 32055
      • Research Site 09
    • Maitland, Florida, United States, 32751
      • Research Site 23
    • Miami, Florida, United States, 33136
      • Research Site 43
    • Miami, Florida, United States, 33134
      • Research Site 38
    • Miami, Florida, United States, 33155
      • Research Site 67
    • Miami, Florida, United States, 33173
      • Research Site 92
    • Miami, Florida, United States, 33185
      • Research Site 31
    • Miami, Florida, United States, 33186
      • Research Site 71
    • Miami Lakes, Florida, United States, 33014
      • Research Site 42
    • New Port Richey, Florida, United States, 34653
      • Research Site 17
    • Ocoee, Florida, United States, 34761
      • Research Site 90
    • Orlando, Florida, United States, 32087
      • Research Site 107
    • Palmetto Bay, Florida, United States, 33157
      • Research Site 05
    • St. Petersburg, Florida, United States, 33709
      • Research Site 95
    • Sunrise, Florida, United States, 33351
      • Research Site 11
    • Viera, Florida, United States, 32940
      • Research Site 46
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Research Site 153
    • Marietta, Georgia, United States, 30060
      • Research Site 04
    • Sandy Springs, Georgia, United States, 30328
      • Research Site 59
  • Idaho
    • Boise, Idaho, United States, 83706
      • Research Site 151
    • Idaho Falls, Idaho, United States, 83404
      • Research Site 101
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Research Site 143
    • Gurnee, Illinois, United States, 60031
      • Research Site 01
    • Gurnee, Illinois, United States, 60031
      • Research Site 141
    • Oak Lawn, Illinois, United States, 60453
      • Research Site 02
  • Indiana
    • South Bend, Indiana, United States, 46635
      • Research Site 135
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Research Site 125
    • Houma, Louisiana, United States, 70363
      • Research Site 45
    • Marrero, Louisiana, United States, 70072
      • Research Site 12
    • Metairie, Louisiana, United States, 70006
      • Research Site 48
    • Metairie, Louisiana, United States, 70006
      • Research Site 124
    • New Orleans, Louisiana, United States, 70127
      • Research Site 34
    • West Monroe, Louisiana, United States, 71291
      • Research Site 25
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Research Site 93
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Research Site 148
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Research Site 140
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Research Site 111
    • Columbia, Missouri, United States, 65201
      • Research Site 137
    • Kansas City, Missouri, United States, 64128
      • Research Site 138
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Research Site 159
    • Las Vegas, Nevada, United States, 89106
      • Research Site 06
    • Las Vegas, Nevada, United States, 89128
      • Research Site 127
    • Las Vegas, Nevada, United States, 28919
      • Research Site 160
    • Las Vegas, Nevada, United States, 33030
      • Research Site 73
    • Las Vegas, Nevada, United States, 89106
      • Research Site 163
    • Reno, Nevada, United States, 89511
      • Research Site 64
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Research Site 129
    • Freehold, New Jersey, United States, 07728
      • Research Site 130
    • Jackson, New Jersey, United States, 08527
      • Research Site 131
  • New York
    • Brooklyn, New York, United States, 11235
      • Research Site 35
    • Great Neck, New York, United States, 11023
      • Research Site 07
    • Hartsdale, New York, United States, 10530
      • Research Site 28
    • New York, New York, United States, 10021
      • Research Site 58
    • New York, New York, United States, 10033
      • Research Site 49
    • Rochester, New York, United States, 14609
      • Research Site 40
  • North Carolina
    • Fayetteville, North Carolina, United States, 84092
      • Research Site 75
    • High Point, North Carolina, United States, 27260
      • Research Site 155
    • Mount Airy, North Carolina, United States, 27030
      • Research Site 69
    • Salisbury, North Carolina, United States, 28144
      • Research Site 116
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Research Site 20
    • Columbus, Ohio, United States, 43215
      • Research Site 88
    • Columbus, Ohio, United States, 43212
      • Research Site 158
    • Mentor, Ohio, United States, 44060
      • Research Site 109
    • Springboro, Ohio, United States, 45066
      • Research Site 118
    • Westlake, Ohio, United States, 44145
      • Research Site 110
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site 157
    • North Charleston, South Carolina, United States, 29405
      • Research Site 61
  • Tennessee
    • Hermitage, Tennessee, United States, 37076
      • Research Site 128
    • Kingsport, Tennessee, United States, 37663
      • Research Site 114
    • Nashville, Tennessee, United States, 37203
      • Research Site 60
    • Nashville, Tennessee, United States, 37211
      • Research Site 103
    • Shelbyville, Tennessee, United States, 37160
      • Research Site 50
  • Texas
    • Bellaire, Texas, United States, 77401
      • Research Site 100
    • Dallas, Texas, United States, 75230
      • Research Site 98
    • Forney, Texas, United States, 75126
      • Research Site 99
    • Houston, Texas, United States, 77024
      • Research Site 154
    • Houston, Texas, United States, 77084
      • Research Site 162
    • Katy, Texas, United States, 77494
      • Research Site 68
    • Lewisville, Texas, United States, 75057
      • Research Site 29
    • McAllen, Texas, United States, 78503
      • Research Site 161
    • Pearland, Texas, United States, 77584
      • Research Site 32
    • Red Oak, Texas, United States, 75154
      • Research Site 30
    • San Antonio, Texas, United States, 78209
      • Research Site 22
    • San Antonio, Texas, United States, 78229
      • Research Site 26
    • San Antonio, Texas, United States, 78249
      • Research Site 21
    • Tomball, Texas, United States, 77375
      • Research Site 80
    • Waco, Texas, United States, 76710
      • Research Site 134
  • Utah
    • Ogden, Utah, United States, 84403
      • Research Site 105
    • Salt Lake City, Utah, United States, 84107
      • Research Site 57
    • Sandy City, Utah, United States, 84092
      • Research Site 65
    • South Ogden, Utah, United States, 84405
      • Research Site 16
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Research Site 77
    • Richmond, Virginia, United States, 23236
      • Research Site 136
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Research Site 97

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

8. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;

9. History of alcoholism, chronic opiate use, or substance addiction in the 12 months before Screening or a positive urine drug screen for opiates or substances of abuse;

   • Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening.
   • Note: Retesting of a positive urine drug screen requires Medical Monitor approval. Positive urine drug screen for all drugs will require verification of prescription for the positive tested substance.

10. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder;

    o Note: A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is not exclusionary, as long as the patient is asymptomatic and well-controlled on stable treatment (ie, stable dose for >6 months prior to Screening), including non-medical therapy.

11. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
12. Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
13. Use of 2 or more commercial doses of ref lux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, and prokinetics) within 1 week prior to the upper GI endoscopy at Screening;

14. Requirement of persistent use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study;

    o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation.

15. If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug;
16. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;

17. Positive test result for H pylori at Screening or diagnosis and treatment of H pylori within 6 weeks prior to randomization;

    o Note: Patients who test positive for H pylori at Screening will be offered treatment according to local standard of care and may be re-screened for eligibility following completion of treatment.

18. Abnormal laboratory results with clinical relevance at Screening as follows:

    • Aspartate aminotransferase (AST), ALT, or alkaline phosphatase level of ≥2 × upper limit of normal (ULN);
    • Total bilirubin level of ≥2 × ULN, unless Gilbert's syndrome is confirmed when direct bilirubin is ≤0.3 mg/dL;
    • Estimated glomerular filtration rate <30 mL/min; or
    • Serum magnesium < lower limit of normal.
19. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);
20. Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;
21. Involvement in another clinical study within 4 weeks of initiation of study drug;
22. Any other clinically relevant condition that would confound study endpoints or adversely affect patient compliance with the study procedures in the medical judgment of the Investigator or Medical Monitor based on previous medical history or findings on Screening assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healing Phase - BLI5100; During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.	Drug: BLI5100; Orally via tablet
Active Comparator: Healing Phase - PPI Control; During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.	Drug: PPI Control; Orally via tablet
Experimental: Maintenance Phase - BLI5100 Low Dose; During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.	Drug: BLI5100; Orally via tablet
Experimental: Maintenance Phase - BLI5100 High Dose; During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.	Drug: BLI5100; Orally via tablet
Active Comparator: Maintenance Phase - PPI Control; During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.	Drug: PPI Control; Orally via tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Healing Phase: Percentage of patients with complete healing by Week 8.	8 Weeks
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.	24 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.	8 Weeks
Maintenance Phase: Percentage of 24-hour heartburn-free days through Week 24.	24 Weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: Leah Hollins, Braintree Laboratories / Sebela Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis
• Other Study ID Numbers: BLI5100-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No