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
1 other identifier
interventional
1,250
1 country
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
Typical duration for phase_3
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedStudy Start
First participant enrolled
October 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2025
CompletedSeptember 24, 2025
September 1, 2025
2.6 years
October 17, 2022
September 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (5)
Healing Phase - BLI5100
EXPERIMENTALDuring the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
Healing Phase - PPI Control
ACTIVE COMPARATORDuring the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
Maintenance Phase - BLI5100 Low Dose
EXPERIMENTALDuring the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
Maintenance Phase - BLI5100 High Dose
EXPERIMENTALDuring the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
Maintenance Phase - PPI Control
ACTIVE COMPARATORDuring the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.
Interventions
Orally via tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
- 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.
- Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder;
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
Research Site 145
Homewood, Alabama, 35209, United States
Research Site 24
Huntsville, Alabama, 35801, United States
Research Site 132
Peoria, Arizona, 85381, United States
Research Site 150
Peoria, Arizona, 85381, United States
Research Site 62
Phoenix, Arizona, 85018, United States
Research Site 27
Tucson, Arizona, 85712, United States
Research Site 87
Little Rock, Arkansas, 72211, United States
Research Site 117
North Little Rock, Arkansas, 72117, United States
Research Site 51
Arcadia, California, 91006, United States
Research Site 66
Bell Gardens, California, 90201, United States
Research Site 156
Camarillo, California, 93012, United States
Research Site 19
Canoga Park, California, 91304, United States
Research Site 94
Chula Vista, California, 91910, United States
Research Site 10
Huntington Park, California, 90255, United States
Research Site 55
La Mesa, California, 91942, United States
Research Site 72
Los Angeles, California, 90017, United States
Research Site 14
San Diego, California, 92120, United States
Research Site 85
Santa Ana, California, 92703, United States
Research Site 13
Santa Ana, California, 92704, United States
Research Site 41
Santa Maria, California, 93458, United States
Research Site 54
Westlake, California, 90057, United States
Research Site 89
Littleton, Colorado, 80120, United States
Research Site 147
Bristol, Connecticut, 06010, United States
Research Site 74
Boca Raton, Florida, 33434, United States
Research Site 108
Cooper City, Florida, 33024, United States
Research Site 91
Doral, Florida, 33172, United States
Research Site 03
Hialeah, Florida, 33013, United States
Research Site 78
Homestead, Florida, 33030, United States
Research Site 09
Lake City, Florida, 32055, United States
Research Site 23
Maitland, Florida, 32751, United States
Research Site 38
Miami, Florida, 33134, United States
Research Site 43
Miami, Florida, 33136, United States
Research Site 67
Miami, Florida, 33155, United States
Research Site 92
Miami, Florida, 33173, United States
Research Site 31
Miami, Florida, 33185, United States
Research Site 71
Miami, Florida, 33186, United States
Research Site 42
Miami Lakes, Florida, 33014, United States
Research Site 17
New Port Richey, Florida, 34653, United States
Research Site 90
Ocoee, Florida, 34761, United States
Research Site 107
Orlando, Florida, 32087, United States
Research Site 05
Palmetto Bay, Florida, 33157, United States
Research Site 95
St. Petersburg, Florida, 33709, United States
Research Site 11
Sunrise, Florida, 33351, United States
Research Site 46
Viera, Florida, 32940, United States
Research Site 153
Atlanta, Georgia, 30329, United States
Research Site 04
Marietta, Georgia, 30060, United States
Research Site 59
Sandy Springs, Georgia, 30328, United States
Research Site 151
Boise, Idaho, 83706, United States
Research Site 101
Idaho Falls, Idaho, 83404, United States
Research Site 143
Glenview, Illinois, 60026, United States
Research Site 01
Gurnee, Illinois, 60031, United States
Research Site 141
Gurnee, Illinois, 60031, United States
Research Site 02
Oak Lawn, Illinois, 60453, United States
Research Site 135
South Bend, Indiana, 46635, United States
Research Site 125
Covington, Louisiana, 70433, United States
Research Site 45
Houma, Louisiana, 70363, United States
Research Site 12
Marrero, Louisiana, 70072, United States
Research Site 124
Metairie, Louisiana, 70006, United States
Research Site 48
Metairie, Louisiana, 70006, United States
Research Site 34
New Orleans, Louisiana, 70127, United States
Research Site 25
West Monroe, Louisiana, 71291, United States
Research Site 93
Chesterfield, Michigan, 48047, United States
Research Site 148
Plymouth, Minnesota, 55446, United States
Research Site 140
Flowood, Mississippi, 39232, United States
Research Site 111
Chesterfield, Missouri, 63005, United States
Research Site 137
Columbia, Missouri, 65201, United States
Research Site 138
Kansas City, Missouri, 64128, United States
Research Site 159
Henderson, Nevada, 89052, United States
Research Site 160
Las Vegas, Nevada, 28919, United States
Research Site 73
Las Vegas, Nevada, 33030, United States
Research Site 06
Las Vegas, Nevada, 89106, United States
Research Site 163
Las Vegas, Nevada, 89106, United States
Research Site 127
Las Vegas, Nevada, 89128, United States
Research Site 64
Reno, Nevada, 89511, United States
Research Site 129
Englewood, New Jersey, 07631, United States
Research Site 130
Freehold, New Jersey, 07728, United States
Research Site 131
Jackson, New Jersey, 08527, United States
Research Site 35
Brooklyn, New York, 11235, United States
Research Site 07
Great Neck, New York, 11023, United States
Research Site 28
Hartsdale, New York, 10530, United States
Research Site 58
New York, New York, 10021, United States
Research Site 49
New York, New York, 10033, United States
Research Site 40
Rochester, New York, 14609, United States
Research Site 75
Fayetteville, North Carolina, 84092, United States
Research Site 155
High Point, North Carolina, 27260, United States
Research Site 69
Mount Airy, North Carolina, 27030, United States
Research Site 116
Salisbury, North Carolina, 28144, United States
Research Site 158
Columbus, Ohio, 43212, United States
Research Site 20
Columbus, Ohio, 43213, United States
Research Site 88
Columbus, Ohio, 43215, United States
Research Site 109
Mentor, Ohio, 44060, United States
Research Site 118
Springboro, Ohio, 45066, United States
Research Site 110
Westlake, Ohio, 44145, United States
Research Site 157
Anderson, South Carolina, 29621, United States
Research Site 61
North Charleston, South Carolina, 29405, United States
Research Site 128
Hermitage, Tennessee, 37076, United States
Research Site 114
Kingsport, Tennessee, 37663, United States
Research Site 60
Nashville, Tennessee, 37203, United States
Research Site 103
Nashville, Tennessee, 37211, United States
Research Site 50
Shelbyville, Tennessee, 37160, United States
Research Site 100
Bellaire, Texas, 77401, United States
Research Site 98
Dallas, Texas, 75230, United States
Research Site 99
Forney, Texas, 75126, United States
Research Site 154
Houston, Texas, 77024, United States
Research Site 162
Houston, Texas, 77084, United States
Research Site 68
Katy, Texas, 77494, United States
Research Site 29
Lewisville, Texas, 75057, United States
Research Site 161
McAllen, Texas, 78503, United States
Research Site 32
Pearland, Texas, 77584, United States
Research Site 30
Red Oak, Texas, 75154, United States
Research Site 22
San Antonio, Texas, 78209, United States
Research Site 26
San Antonio, Texas, 78229, United States
Research Site 21
San Antonio, Texas, 78249, United States
Research Site 80
Tomball, Texas, 77375, United States
Research Site 134
Waco, Texas, 76710, United States
Research Site 105
Ogden, Utah, 84403, United States
Research Site 57
Salt Lake City, Utah, 84107, United States
Research Site 65
Sandy City, Utah, 84092, United States
Research Site 16
South Ogden, Utah, 84405, United States
Research Site 77
Chesapeake, Virginia, 23320, United States
Research Site 136
Richmond, Virginia, 23236, United States
Research Site 97
Morgantown, West Virginia, 26505, United States
Study Officials
- STUDY DIRECTOR
Leah Hollins
Braintree Laboratories / Sebela Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
October 30, 2022
Primary Completion
June 16, 2025
Study Completion
June 16, 2025
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share