A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis
- Conditions
- Erosive Esophagitis
- Interventions
- Drug: PPI Control
- Registration Number
- NCT05587309
- Lead Sponsor
- Braintree Laboratories
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- Aged ≥18 years at the time of signing informed consent;
- Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
- Current evidence of EE of LA grades A to D based on an upper GI endoscopy;
- Able to understand and comply with the protocol requirements;
- Willing and able to provide written informed consent at Screening;
- 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.
- 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.
- If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.
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Unable to undergo an upper GI endoscopy;
-
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.
-
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;
-
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;
-
History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease;
-
History of acid-suppressive, esophageal, or gastric surgery;
o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.
-
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.
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History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
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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.
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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.
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Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
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Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
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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;
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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.
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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;
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Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;
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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.
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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.
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Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);
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Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;
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Involvement in another clinical study within 4 weeks of initiation of study drug;
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healing Phase - BLI5100 BLI5100 During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks. Healing Phase - PPI Control PPI Control During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks. Maintenance Phase - BLI5100 Low Dose BLI5100 During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks. Maintenance Phase - PPI Control PPI Control During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks. Maintenance Phase - BLI5100 High Dose BLI5100 During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- 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
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 41
🇺🇸Santa Maria, California, United States
Research Site 54
🇺🇸Westlake, California, United States
Research Site 89
🇺🇸Littleton, Colorado, United States
Research Site 13
🇺🇸Santa Ana, California, 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 42
🇺🇸Miami Lakes, 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 107
🇺🇸Orlando, Florida, United States
Research Site 05
🇺🇸Palmetto Bay, Florida, United States
Research Site 95
🇺🇸Saint Petersburg, Florida, United States
Research Site 11
🇺🇸Sunrise, Florida, United States
Research Site 17
🇺🇸New Port Richey, Florida, United States
Research Site 90
🇺🇸Ocoee, 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
🇺🇸Oaklawn, 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, 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