New pill aims to heal Acid-Damaged esophagus

NCT ID NCT05587309

Disease control Sponsor: Braintree Laboratories Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called BLI5100 in 1250 adults with erosive esophagitis, a condition where stomach acid damages the esophagus. Participants took either BLI5100 or a standard PPI (proton pump inhibitor) daily for up to 8 weeks to see if it healed the damage, then for 24 more weeks to see if it kept the damage from coming back. The goal was to compare the new drug's safety and effectiveness against a current treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BLI5100 (a drug taken as a tablet)
What this could lead to: If it works, this could offer a new treatment option for healing and preventing the return of erosive esophagitis, a condition where stomach acid damages the esophagus.
What could go wrong: This is a completed Phase 3 trial, but results are not yet public. The new drug may not be more effective than existing PPIs, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,250 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

esophagitis peptic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erosive esophagitis

Contacts and locations

Locations

Research Site 01

Gurnee, Illinois, 60031, United States
Research Site 02

Oak Lawn, Illinois, 60453, United States
Research Site 03

Hialeah, Florida, 33013, United States
Research Site 04

Marietta, Georgia, 30060, United States
Research Site 05

Palmetto Bay, Florida, 33157, United States
Research Site 06

Las Vegas, Nevada, 89106, United States
Research Site 07

Great Neck, New York, 11023, United States
Research Site 09

Lake City, Florida, 32055, United States
Research Site 10

Huntington Park, California, 90255, United States
Research Site 100

Bellaire, Texas, 77401, United States
Research Site 101

Idaho Falls, Idaho, 83404, United States
Research Site 103

Nashville, Tennessee, 37211, United States
Research Site 105

Ogden, Utah, 84403, United States
Research Site 107

Orlando, Florida, 32087, United States
Research Site 108

Cooper City, Florida, 33024, United States
Research Site 109

Mentor, Ohio, 44060, United States
Research Site 11

Sunrise, Florida, 33351, United States
Research Site 110

Westlake, Ohio, 44145, United States
Research Site 111

Chesterfield, Missouri, 63005, United States
Research Site 114

Kingsport, Tennessee, 37663, United States
Research Site 116

Salisbury, North Carolina, 28144, United States
Research Site 117

North Little Rock, Arkansas, 72117, United States
Research Site 118

Springboro, Ohio, 45066, United States
Research Site 12

Marrero, Louisiana, 70072, United States
Research Site 124

Metairie, Louisiana, 70006, United States
Research Site 125

Covington, Louisiana, 70433, United States
Research Site 127

Las Vegas, Nevada, 89128, United States
Research Site 128

Hermitage, Tennessee, 37076, United States
Research Site 129

Englewood, New Jersey, 07631, United States
Research Site 13

Santa Ana, California, 92704, United States
Research Site 130

Freehold, New Jersey, 07728, United States
Research Site 131

Jackson, New Jersey, 08527, United States
Research Site 132

Peoria, Arizona, 85381, United States
Research Site 134

Waco, Texas, 76710, United States
Research Site 135

South Bend, Indiana, 46635, United States
Research Site 136

Richmond, Virginia, 23236, United States
Research Site 137

Columbia, Missouri, 65201, United States
Research Site 138

Kansas City, Missouri, 64128, United States
Research Site 14

San Diego, California, 92120, United States
Research Site 140

Flowood, Mississippi, 39232, United States
Research Site 141

Gurnee, Illinois, 60031, United States
Research Site 143

Glenview, Illinois, 60026, United States
Research Site 145

Homewood, Alabama, 35209, United States
Research Site 147

Bristol, Connecticut, 06010, United States
Research Site 148

Plymouth, Minnesota, 55446, United States
Research Site 150

Peoria, Arizona, 85381, United States
Research Site 151

Boise, Idaho, 83706, United States
Research Site 153

Atlanta, Georgia, 30329, United States
Research Site 154

Houston, Texas, 77024, United States
Research Site 155

High Point, North Carolina, 27260, United States
Research Site 156

Camarillo, California, 93012, United States
Research Site 157

Anderson, South Carolina, 29621, United States
Research Site 158

Columbus, Ohio, 43212, United States
Research Site 159

Henderson, Nevada, 89052, United States
Research Site 16

South Ogden, Utah, 84405, United States
Research Site 160

Las Vegas, Nevada, 28919, United States
Research Site 161

McAllen, Texas, 78503, United States
Research Site 162

Houston, Texas, 77084, United States
Research Site 163

Las Vegas, Nevada, 89106, United States
Research Site 17

New Port Richey, Florida, 34653, United States
Research Site 19

Canoga Park, California, 91304, United States
Research Site 20

Columbus, Ohio, 43213, United States
Research Site 21

San Antonio, Texas, 78249, United States
Research Site 22

San Antonio, Texas, 78209, United States
Research Site 23

Maitland, Florida, 32751, United States
Research Site 24

Huntsville, Alabama, 35801, United States
Research Site 25

West Monroe, Louisiana, 71291, United States
Research Site 26

San Antonio, Texas, 78229, United States
Research Site 27

Tucson, Arizona, 85712, United States
Research Site 28

Hartsdale, New York, 10530, United States
Research Site 29

Lewisville, Texas, 75057, United States
Research Site 30

Red Oak, Texas, 75154, United States
Research Site 31

Miami, Florida, 33185, United States
Research Site 32

Pearland, Texas, 77584, United States
Research Site 34

New Orleans, Louisiana, 70127, United States
Research Site 35

Brooklyn, New York, 11235, United States
Research Site 38

Miami, Florida, 33134, United States
Research Site 40

Rochester, New York, 14609, United States
Research Site 41

Santa Maria, California, 93458, United States
Research Site 42

Miami Lakes, Florida, 33014, United States
Research Site 43

Miami, Florida, 33136, United States
Research Site 45

Houma, Louisiana, 70363, United States
Research Site 46

Viera, Florida, 32940, United States
Research Site 48

Metairie, Louisiana, 70006, United States
Research Site 49

New York, New York, 10033, United States
Research Site 50

Shelbyville, Tennessee, 37160, United States
Research Site 51

Arcadia, California, 91006, United States
Research Site 54

Westlake, California, 90057, United States
Research Site 55

La Mesa, California, 91942, United States
Research Site 57

Salt Lake City, Utah, 84107, United States
Research Site 58

New York, New York, 10021, United States
Research Site 59

Sandy Springs, Georgia, 30328, United States
Research Site 60

Nashville, Tennessee, 37203, United States
Research Site 61

North Charleston, South Carolina, 29405, United States
Research Site 62

Phoenix, Arizona, 85018, United States
Research Site 64

Reno, Nevada, 89511, United States
Research Site 65

Sandy City, Utah, 84092, United States
Research Site 66

Bell Gardens, California, 90201, United States
Research Site 67

Miami, Florida, 33155, United States
Research Site 68

Katy, Texas, 77494, United States
Research Site 69

Mount Airy, North Carolina, 27030, United States
Research Site 71

Miami, Florida, 33186, United States
Research Site 72

Los Angeles, California, 90017, United States
Research Site 73

Las Vegas, Nevada, 33030, United States
Research Site 74

Boca Raton, Florida, 33434, United States
Research Site 75

Fayetteville, North Carolina, 84092, United States
Research Site 77

Chesapeake, Virginia, 23320, United States
Research Site 78

Homestead, Florida, 33030, United States
Research Site 80

Tomball, Texas, 77375, United States
Research Site 85

Santa Ana, California, 92703, United States
Research Site 87

Little Rock, Arkansas, 72211, United States
Research Site 88

Columbus, Ohio, 43215, United States
Research Site 89

Littleton, Colorado, 80120, United States
Research Site 90

Ocoee, Florida, 34761, United States
Research Site 91

Doral, Florida, 33172, United States
Research Site 92

Miami, Florida, 33173, United States
Research Site 93

Chesterfield, Michigan, 48047, United States
Research Site 94

Chula Vista, California, 91910, United States
Research Site 95

St. Petersburg, Florida, 33709, United States
Research Site 97

Morgantown, West Virginia, 26505, United States
Research Site 98

Dallas, Texas, 75230, United States
Research Site 99

Forney, Texas, 75126, United States

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