A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
NCT ID: NCT05587309
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1250 participants
INTERVENTIONAL
2022-10-30
2025-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Healing Phase - BLI5100
During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
BLI5100
Orally via tablet
Healing Phase - PPI Control
During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
PPI Control
Orally via tablet
Maintenance Phase - BLI5100 Low Dose
During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
BLI5100
Orally via tablet
Maintenance Phase - BLI5100 High Dose
During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
BLI5100
Orally via tablet
Maintenance Phase - PPI Control
During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.
PPI Control
Orally via tablet
Interventions
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BLI5100
Orally via tablet
PPI Control
Orally via tablet
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Leah Hollins
Role: STUDY_DIRECTOR
Braintree Laboratories / Sebela Pharmaceuticals
Locations
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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
Research Site 156
Camarillo, California, United States
Research Site 19
Canoga Park, California, United States
Research Site 94
Chula Vista, California, United States
Research Site 10
Huntington Park, California, United States
Research Site 55
La Mesa, California, United States
Research Site 72
Los Angeles, California, United States
Research Site 14
San Diego, California, United States
Research Site 85
Santa Ana, California, United States
Research Site 13
Santa Ana, California, United States
Research Site 41
Santa Maria, California, United States
Research Site 54
Westlake, California, United States
Research Site 89
Littleton, Colorado, United States
Research Site 147
Bristol, Connecticut, United States
Research Site 74
Boca Raton, Florida, United States
Research Site 108
Cooper City, Florida, United States
Research Site 91
Doral, Florida, United States
Research Site 03
Hialeah, Florida, United States
Research Site 78
Homestead, Florida, United States
Research Site 09
Lake City, Florida, United States
Research Site 23
Maitland, Florida, United States
Research Site 38
Miami, Florida, United States
Research Site 43
Miami, Florida, United States
Research Site 67
Miami, Florida, United States
Research Site 92
Miami, Florida, United States
Research Site 31
Miami, Florida, United States
Research Site 71
Miami, Florida, United States
Research Site 42
Miami Lakes, Florida, United States
Research Site 17
New Port Richey, Florida, United States
Research Site 90
Ocoee, Florida, United States
Research Site 107
Orlando, Florida, United States
Research Site 05
Palmetto Bay, Florida, United States
Research Site 95
St. Petersburg, Florida, United States
Research Site 11
Sunrise, Florida, United States
Research Site 46
Viera, Florida, United States
Research Site 153
Atlanta, Georgia, United States
Research Site 04
Marietta, Georgia, United States
Research Site 59
Sandy Springs, Georgia, United States
Research Site 151
Boise, Idaho, United States
Research Site 101
Idaho Falls, Idaho, United States
Research Site 143
Glenview, Illinois, United States
Research Site 01
Gurnee, Illinois, United States
Research Site 141
Gurnee, Illinois, United States
Research Site 02
Oak Lawn, Illinois, United States
Research Site 135
South Bend, Indiana, United States
Research Site 125
Covington, Louisiana, United States
Research Site 45
Houma, Louisiana, United States
Research Site 12
Marrero, Louisiana, United States
Research Site 124
Metairie, Louisiana, United States
Research Site 48
Metairie, Louisiana, United States
Research Site 34
New Orleans, Louisiana, United States
Research Site 25
West Monroe, Louisiana, United States
Research Site 93
Chesterfield, Michigan, United States
Research Site 148
Plymouth, Minnesota, United States
Research Site 140
Flowood, Mississippi, United States
Research Site 111
Chesterfield, Missouri, United States
Research Site 137
Columbia, Missouri, United States
Research Site 138
Kansas City, Missouri, United States
Research Site 159
Henderson, Nevada, United States
Research Site 160
Las Vegas, Nevada, United States
Research Site 73
Las Vegas, Nevada, United States
Research Site 06
Las Vegas, Nevada, United States
Research Site 163
Las Vegas, Nevada, United States
Research Site 127
Las Vegas, Nevada, United States
Research Site 64
Reno, Nevada, United States
Research Site 129
Englewood, New Jersey, United States
Research Site 130
Freehold, New Jersey, United States
Research Site 131
Jackson, New Jersey, United States
Research Site 35
Brooklyn, New York, United States
Research Site 07
Great Neck, New York, United States
Research Site 28
Hartsdale, New York, United States
Research Site 58
New York, New York, United States
Research Site 49
New York, New York, United States
Research Site 40
Rochester, New York, United States
Research Site 75
Fayetteville, North Carolina, United States
Research Site 155
High Point, North Carolina, United States
Research Site 69
Mount Airy, North Carolina, United States
Research Site 116
Salisbury, North Carolina, United States
Research Site 158
Columbus, Ohio, United States
Research Site 20
Columbus, Ohio, United States
Research Site 88
Columbus, Ohio, United States
Research Site 109
Mentor, Ohio, United States
Research Site 118
Springboro, Ohio, United States
Research Site 110
Westlake, Ohio, United States
Research Site 157
Anderson, South Carolina, United States
Research Site 61
North Charleston, South Carolina, United States
Research Site 128
Hermitage, Tennessee, United States
Research Site 114
Kingsport, Tennessee, United States
Research Site 60
Nashville, Tennessee, United States
Research Site 103
Nashville, Tennessee, United States
Research Site 50
Shelbyville, Tennessee, United States
Research Site 100
Bellaire, Texas, United States
Research Site 98
Dallas, Texas, United States
Research Site 99
Forney, Texas, United States
Research Site 154
Houston, Texas, United States
Research Site 162
Houston, Texas, United States
Research Site 68
Katy, Texas, United States
Research Site 29
Lewisville, Texas, United States
Research Site 161
McAllen, Texas, United States
Research Site 32
Pearland, Texas, United States
Research Site 30
Red Oak, Texas, United States
Research Site 22
San Antonio, Texas, United States
Research Site 26
San Antonio, Texas, United States
Research Site 21
San Antonio, Texas, United States
Research Site 80
Tomball, Texas, United States
Research Site 134
Waco, Texas, United States
Research Site 105
Ogden, Utah, United States
Research Site 57
Salt Lake City, Utah, United States
Research Site 65
Sandy City, Utah, United States
Research Site 16
South Ogden, Utah, United States
Research Site 77
Chesapeake, Virginia, United States
Research Site 136
Richmond, Virginia, United States
Research Site 97
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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BLI5100-301
Identifier Type: -
Identifier Source: org_study_id
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