Erosive EsophagitisPhase 3NCT05587309
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
A Phase 3 study testing BLI5100 in people with Erosive Esophagitis, run by Braintree Laboratories at 122 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- BLI5100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 122 sitesUnited States
- Study dates
- 30 Oct 2022to 16 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 34Show fewer
- 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;
- 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.
- Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
- Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
- 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;
- 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.
- 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;
- Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;
- 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.
- 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.
- Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);
- Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;
- Involvement in another clinical study within 4 weeks of initiation of study drug;
- 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.
Trial locations and contacts
122 sites in 1 country.
122 sites in 1 country
United States122 sites
Research Site 157
Anderson, South Carolina, 29621
Research Site 51
Arcadia, California, 91006
Research Site 153
Atlanta, Georgia, 30329
Research Site 66
Bell Gardens, California, 90201
Research Site 100
Bellaire, Texas, 77401
Research Site 74
Boca Raton, Florida, 33434
Research Site 151
Boise, Idaho, 83706
Research Site 147
Bristol, Connecticut, 06010
Research Site 35
Brooklyn, New York, 11235
Research Site 156
Camarillo, California, 93012
Research Site 19
Canoga Park, California, 91304
Research Site 77
Chesapeake, Virginia, 23320
Research Site 93
Chesterfield, Michigan, 48047
Research Site 111
Chesterfield, Missouri, 63005
Research Site 94
Chula Vista, California, 91910
Research Site 137
Columbia, Missouri, 65201
Research Site 158
Columbus, Ohio, 43212
Research Site 20
Columbus, Ohio, 43213
Research Site 88
Columbus, Ohio, 43215
Research Site 108
Cooper City, Florida, 33024
Research Site 125
Covington, Louisiana, 70433
Research Site 98
Dallas, Texas, 75230
Research Site 91
Doral, Florida, 33172
Research Site 129
Englewood, New Jersey, 07631
Research Site 75
Fayetteville, North Carolina, 84092
Research Site 140
Flowood, Mississippi, 39232
Research Site 99
Forney, Texas, 75126
Research Site 130
Freehold, New Jersey, 07728
Research Site 143
Glenview, Illinois, 60026
Research Site 07
Great Neck, New York, 11023
Research Site 01
Gurnee, Illinois, 60031
Research Site 141
Gurnee, Illinois, 60031
Research Site 28
Hartsdale, New York, 10530
Research Site 159
Henderson, Nevada, 89052
Research Site 128
Hermitage, Tennessee, 37076
Research Site 03
Hialeah, Florida, 33013
Research Site 155
High Point, North Carolina, 27260
Research Site 78
Homestead, Florida, 33030
Research Site 145
Homewood, Alabama, 35209
Research Site 45
Houma, Louisiana, 70363
Research Site 154
Houston, Texas, 77024
Research Site 162
Houston, Texas, 77084
Research Site 10
Huntington Park, California, 90255
Research Site 24
Huntsville, Alabama, 35801
Research Site 101
Idaho Falls, Idaho, 83404
Research Site 131
Jackson, New Jersey, 08527
Research Site 138
Kansas City, Missouri, 64128
Research Site 68
Katy, Texas, 77494
Research Site 114
Kingsport, Tennessee, 37663
Research Site 55
La Mesa, California, 91942
Research Site 09
Lake City, Florida, 32055
Research Site 160
Las Vegas, Nevada, 28919
Research Site 73
Las Vegas, Nevada, 33030
Research Site 06
Las Vegas, Nevada, 89106
Research Site 163
Las Vegas, Nevada, 89106
Research Site 127
Las Vegas, Nevada, 89128
Research Site 29
Lewisville, Texas, 75057
Research Site 87
Little Rock, Arkansas, 72211
Research Site 89
Littleton, Colorado, 80120
Research Site 72
Los Angeles, California, 90017
Research Site 23
Maitland, Florida, 32751
Research Site 04
Marietta, Georgia, 30060
Research Site 12
Marrero, Louisiana, 70072
Research Site 161
McAllen, Texas, 78503
Research Site 109
Mentor, Ohio, 44060
Research Site 124
Metairie, Louisiana, 70006
Research Site 48
Metairie, Louisiana, 70006
Research Site 38
Miami, Florida, 33134
Research Site 43
Miami, Florida, 33136
Research Site 67
Miami, Florida, 33155
Research Site 92
Miami, Florida, 33173
Research Site 31
Miami, Florida, 33185
Research Site 71
Miami, Florida, 33186
Research Site 42
Miami Lakes, Florida, 33014
Research Site 97
Morgantown, West Virginia, 26505
Research Site 69
Mount Airy, North Carolina, 27030
Research Site 60
Nashville, Tennessee, 37203
Research Site 103
Nashville, Tennessee, 37211
Research Site 34
New Orleans, Louisiana, 70127
Research Site 17
New Port Richey, Florida, 34653
Research Site 58
New York, New York, 10021
Research Site 49
New York, New York, 10033
Research Site 61
North Charleston, South Carolina, 29405
Research Site 117
North Little Rock, Arkansas, 72117
Research Site 02
Oak Lawn, Illinois, 60453
Research Site 90
Ocoee, Florida, 34761
Research Site 105
Ogden, Utah, 84403
Research Site 107
Orlando, Florida, 32087
Research Site 05
Palmetto Bay, Florida, 33157
Research Site 32
Pearland, Texas, 77584
Research Site 132
Peoria, Arizona, 85381
Research Site 150
Peoria, Arizona, 85381
Research Site 62
Phoenix, Arizona, 85018
Research Site 148
Plymouth, Minnesota, 55446
Research Site 30
Red Oak, Texas, 75154
Research Site 64
Reno, Nevada, 89511
Research Site 136
Richmond, Virginia, 23236
Research Site 40
Rochester, New York, 14609
Research Site 116
Salisbury, North Carolina, 28144
Research Site 57
Salt Lake City, Utah, 84107
Research Site 22
San Antonio, Texas, 78209
Research Site 26
San Antonio, Texas, 78229
Research Site 21
San Antonio, Texas, 78249
Research Site 14
San Diego, California, 92120
Research Site 65
Sandy City, Utah, 84092
Research Site 59
Sandy Springs, Georgia, 30328
Research Site 85
Santa Ana, California, 92703
Research Site 13
Santa Ana, California, 92704
Research Site 41
Santa Maria, California, 93458
Research Site 50
Shelbyville, Tennessee, 37160
Research Site 135
South Bend, Indiana, 46635
Research Site 16
South Ogden, Utah, 84405
Research Site 118
Springboro, Ohio, 45066
Research Site 95
St. Petersburg, Florida, 33709
Research Site 11
Sunrise, Florida, 33351
Research Site 80
Tomball, Texas, 77375
Research Site 27
Tucson, Arizona, 85712
Research Site 46
Viera, Florida, 32940
Research Site 134
Waco, Texas, 76710
Research Site 25
West Monroe, Louisiana, 71291
Research Site 54
Westlake, California, 90057
Research Site 110
Westlake, Ohio, 44145
About this study
Official title: 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.
- Conditions
- Erosive Esophagitis
- Being tested
- BLI5100, PPI Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI5100Drug
Orally via tablet
PPI ControlDrug
Orally via tablet
| Study group | Role | What they receive |
|---|---|---|
| Healing Phase - BLI5100 | Experimental | During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks. Receives: Drug: BLI5100 |
| Healing Phase - PPI Control | Active comparator | During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks. Receives: Drug: PPI Control |
| Maintenance Phase - BLI5100 Low Dose | Experimental | During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks. Receives: Drug: BLI5100 |
| Maintenance Phase - BLI5100 High Dose | Experimental | During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks. Receives: Drug: BLI5100 |
| Maintenance Phase - PPI Control | Active comparator | During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks. Receives: Drug: PPI Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Phase: Percentage of patients with complete healing by Week 8.
Measured: 8 Weeks
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
Measured: 24 Weeks
Secondary outcomes (2)
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.
Measured: 8 Weeks
Maintenance Phase: Percentage of 24-hour heartburn-free days through Week 24.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start30 Oct 2022
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leah Hollins, Study director, Braintree Laboratories / Sebela Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587309
- Sponsor's protocol ID
- BLI5100-301
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Two-Phase, Active-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT05587309
- Acronym / sponsor ID
- BLI5100-301
- Conditions
- Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healing Phase - BLI5100 | Experimental | Drug: BLI5100During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks. |
| Healing Phase - PPI Control | Active comparator | Drug: PPI ControlDuring the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks. |
| Maintenance Phase - BLI5100 Low Dose | Experimental | Drug: BLI5100During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks. |
| Maintenance Phase - BLI5100 High Dose | Experimental | Drug: BLI5100During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks. |
| Maintenance Phase - PPI Control | Active comparator | Drug: PPI ControlDuring the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (34 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLI5100Orally via tablet | Drug | Healing Phase - BLI5100, Maintenance Phase - BLI5100 High Dose, Maintenance Phase - BLI5100 Low Dose |
| PPI ControlOrally via tablet | Drug | Healing Phase - PPI Control, Maintenance Phase - PPI Control |
Primary outcome
Healing Phase: Percentage of patients with complete healing by Week 8.
Time frame: 8 Weeks
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
Time frame: 24 Weeks
2 secondary outcomes
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.
Time frame: 8 Weeks
Maintenance Phase: Percentage of 24-hour heartburn-free days through Week 24.
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Hollins study director
Braintree Laboratories / Sebela Pharmaceuticals
122 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BLI5100 in people with Erosive Esophagitis, run by Braintree Laboratories at 122 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Phase: Percentage of patients with complete healing by Week 8. (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.