A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease

NCT05890001 | Completed Phase 3 FDA Drug

• 1 other identifier: BLI5100-303
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 60

Brief Summary

The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).

Conditions

Non-erosive Reflux Disease; Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• Frequency of treatment-emergent adverse events

  31 Weeks

Study Arms (2)

BLI5100 Low Dose

EXPERIMENTAL

Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.

Drug: BLI5100

BLI5100 High Dose

EXPERIMENTAL

Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.

Drug: BLI5100

Interventions

BLI5100 DRUG

Patients will take BLI5100 once daily, orally, for up to 29 weeks.

BLI5100 High Dose; BLI5100 Low Dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed the BLI5100-301 or BLI5100-302 study with no serious AE (SAE) related to study drug and no major Protocol Deviations;
• Able to understand and comply with the protocol requirements;
• Willing and able to provide written informed consent at Screening;
• Is a female of non-childbearing potential, 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;
• Have documented healed EE (BLI5100-301 study patients only).

You may not qualify if:

• History of alcoholism, or substance abuse/addiction in the year before enrollment in the BLI5100-301 and BLI5100-302 studies;
• Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies.
• 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.
• Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies;
• Requirement of persistent (\>3 times per week for \>30 days) 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;
• Abnormal laboratory results with clinical relevance at Screening as follows:
• Aspartate aminotransferase (AST), alanine aminotransferase (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.
• Note: A lab value obtained during the Screening period may be retested once with Medical Monitor approval.
• Abnormal ECG of clinical significance;
• Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) 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.

Sponsors & Collaborators

• Braintree Laboratories: lead

Study Sites (60)

Research Site 24

Huntsville, Alabama, 35801, United States

Location

Research Site 62

Phoenix, Arizona, 85018, United States

Location

Research Site 27

Tucson, Arizona, 85712, United States

Location

Research Site 87

Little Rock, Arkansas, 72211, United States

Location

Research Site 117

North Little Rock, Arkansas, 72117, United States

Location

Research Site 94

Chula Vista, California, 91910, United States

Location

Research Site 10

Huntington Park, California, 90255, United States

Location

Research Site 55

La Mesa, California, 91942, United States

Location

Research Site 72

Los Angeles, California, 90017, United States

Location

Research Site 54

Los Angeles, California, 90057, United States

Location

Research Site 13

Santa Ana, California, 92704, United States

Location

Research Site 41

Santa Maria, California, 93458, United States

Location

Research Site 108

Cooper City, Florida, 33024, United States

Location

Research Site 91

Doral, Florida, 33172, United States

Location

Research Site 78

Homestead, Florida, 33030, United States

Location

Research Site 23

Maitland, Florida, 32751, United States

Location

Research Site 38

Miami, Florida, 33134, United States

Location

Research Site 43

Miami, Florida, 33136, United States

Location

Research Site 67

Miami, Florida, 33155, United States

Location

Research Site 92

Miami, Florida, 33173, United States

Location

Research Site 71

Miami, Florida, 33186, United States

Location

Research Site 42

Miami Lakes, Florida, 33014, United States

Location

Research Site 17

New Port Richey, Florida, 34653, United States

Location

Research Site 90

Ocoee, Florida, 34761, United States

Location

Research Site 05

Palmetto Bay, Florida, 33157, United States

Location

Research Site 11

Sunrise, Florida, 33351, United States

Location

Research Site 46

Viera, Florida, 32940, United States

Location

Research Site 59

Sandy Springs, Georgia, 30328, United States

Location

Research Site 01

Gurnee, Illinois, 60031, United States

Location

Research Site 02

Oak Lawn, Illinois, 60453, United States

Location

Research Site 45

Houma, Louisiana, 70363, United States

Location

Research Site 12

Marrero, Louisiana, 70072, United States

Location

Research Site 48

Metairie, Louisiana, 70006, United States

Location

Research Site 34

New Orleans, Louisiana, 70127, United States

Location

Research Site 111

Chesterfield, Missouri, 63005, United States

Location

Research Site 06

Las Vegas, Nevada, 89106, United States

Location

Research Site 64

Reno, Nevada, 89511, United States

Location

Research Site 35

Brooklyn, New York, 11235, United States

Location

Research Site 07

Great Neck, New York, 11023, United States

Location

Research Site 28

Hartsdale, New York, 10530, United States

Location

Research Site 49

New York, New York, 10033, United States

Location

Research Site 40

Rochester, New York, 14609, United States

Location

Research Site 75

Fayetteville, North Carolina, 28304, United States

Location

Research Site 20

Columbus, Ohio, 43213, United States

Location

Research Site 88

Columbus, Ohio, 43215, United States

Location

Research Site 109

Mentor, Ohio, 44060, United States

Location

Research Site 110

Westlake, Ohio, 44145, United States

Location

Research Site 60

Nashville, Tennessee, 37203, United States

Location

Research Site 103

Nashville, Tennessee, 37211, United States

Location

Research Site 100

Bellaire, Texas, 77401, United States

Location

Research Site 98

Dallas, Texas, 75230, United States

Location

Research Site 99

Forney, Texas, 75126, United States

Location

Research Site 29

Lewisville, Texas, 75057, United States

Location

Research Site 32

Pearland, Texas, 77584, United States

Location

Research Site 30

Red Oak, Texas, 75154, United States

Location

Research Site 22

San Antonio, Texas, 78209, United States

Location

Research Site 26

San Antonio, Texas, 78229, United States

Location

Research Site 21

San Antonio, Texas, 78249, United States

Location

Research Site 65

Sandy City, Utah, 84092, United States

Location

Research Site 16

South Ogden, Utah, 84405, United States

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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: May 5, 2023
• First Posted: June 5, 2023
• Study Start: April 5, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (60)