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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Non-erosive Reflux Disease; Erosive Esophagitis
• Intervention / Treatment: Drug: BLI5100

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Research Site 24
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Research Site 62
    • Tucson, Arizona, United States, 85712
      • Research Site 27
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Research Site 87
    • North Little Rock, Arkansas, United States, 72117
      • Research Site 117
  • California
    • Chula Vista, California, United States, 91910
      • Research Site 94
    • Huntington Park, California, United States, 90255
      • Research Site 10
    • La Mesa, California, United States, 91942
      • Research Site 55
    • Los Angeles, California, United States, 90017
      • Research Site 72
    • Los Angeles, California, United States, 90057
      • Research Site 54
    • Santa Ana, California, United States, 92704
      • Research Site 13
    • Santa Maria, California, United States, 93458
      • Research Site 41
  • Florida
    • Cooper City, Florida, United States, 33024
      • Research Site 108
    • Doral, Florida, United States, 33172
      • Research Site 91
    • Homestead, Florida, United States, 33030
      • Research Site 78
    • Maitland, Florida, United States, 32751
      • Research Site 23
    • Miami, Florida, United States, 33136
      • Research Site 43
    • Miami, Florida, United States, 33134
      • Research Site 38
    • Miami, Florida, United States, 33155
      • Research Site 67
    • Miami, Florida, United States, 33173
      • Research Site 92
    • Miami, Florida, United States, 33186
      • Research Site 71
    • Miami Lakes, Florida, United States, 33014
      • Research Site 42
    • New Port Richey, Florida, United States, 34653
      • Research Site 17
    • Ocoee, Florida, United States, 34761
      • Research Site 90
    • Palmetto Bay, Florida, United States, 33157
      • Research Site 05
    • Sunrise, Florida, United States, 33351
      • Research Site 11
    • Viera, Florida, United States, 32940
      • Research Site 46
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Research Site 59
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Research Site 01
    • Oak Lawn, Illinois, United States, 60453
      • Research Site 02
  • Louisiana
    • Houma, Louisiana, United States, 70363
      • Research Site 45
    • Marrero, Louisiana, United States, 70072
      • Research Site 12
    • Metairie, Louisiana, United States, 70006
      • Research Site 48
    • New Orleans, Louisiana, United States, 70127
      • Research Site 34
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Research Site 111
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Research Site 06
    • Reno, Nevada, United States, 89511
      • Research Site 64
  • New York
    • Brooklyn, New York, United States, 11235
      • Research Site 35
    • Great Neck, New York, United States, 11023
      • Research Site 07
    • Hartsdale, New York, United States, 10530
      • Research Site 28
    • New York, New York, United States, 10033
      • Research Site 49
    • Rochester, New York, United States, 14609
      • Research Site 40
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Research Site 75
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Research Site 20
    • Columbus, Ohio, United States, 43215
      • Research Site 88
    • Mentor, Ohio, United States, 44060
      • Research Site 109
    • Westlake, Ohio, United States, 44145
      • Research Site 110
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Research Site 60
    • Nashville, Tennessee, United States, 37211
      • Research Site 103
  • Texas
    • Bellaire, Texas, United States, 77401
      • Research Site 100
    • Dallas, Texas, United States, 75230
      • Research Site 98
    • Forney, Texas, United States, 75126
      • Research Site 99
    • Lewisville, Texas, United States, 75057
      • Research Site 29
    • Pearland, Texas, United States, 77584
      • Research Site 32
    • Red Oak, Texas, United States, 75154
      • Research Site 30
    • San Antonio, Texas, United States, 78209
      • Research Site 22
    • San Antonio, Texas, United States, 78229
      • Research Site 26
    • San Antonio, Texas, United States, 78249
      • Research Site 21
  • Utah
    • Sandy, Utah, United States, 84092
      • Research Site 65
    • South Ogden, Utah, United States, 84405
      • Research Site 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Have completed the BLI5100-301 or BLI5100-302 study with no serious AE (SAE) related to study drug and no major Protocol Deviations;
2. Able to understand and comply with the protocol requirements;
3. Willing and able to provide written informed consent at Screening;
4. 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;
5. 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;
6. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug;
7. Have documented healed EE (BLI5100-301 study patients only).

Exclusion Criteria:

1. 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.
2. A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is exclusionary, unless the patient is asymptomatic and well-controlled. Stable treatment, including non-medical therapy, is preferred, but minor adjustments can be made and should be consulted with the Medical Monitor;
3. 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;

4. 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.

5. 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;

6. 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.
7. Abnormal ECG of clinical significance;
8. Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) within 4 weeks of initiation of study drug;
9. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI5100 Low Dose; Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks.	Drug: BLI5100; Patients will take BLI5100 once daily, orally, for up to 29 weeks.
Experimental: BLI5100 High Dose; Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks.	Drug: BLI5100; Patients will take BLI5100 once daily, orally, for up to 29 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of treatment-emergent adverse events	31 Weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Esophagitis
• Other Study ID Numbers: BLI5100-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No