A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

Non-erosive Reflux Disease Clinical Trial

Official title:

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05587322
• Other study ID #: BLI5100-302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 6, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the Treatment Phase of the study is to evaluate the safety and efficacy of 4 weeks of once daily oral administration of BLI5100 low dose, BLI5100 high dose, or placebo in patients with NERD. The objective of the Extension Phase of the study is to evaluate the safety of extended exposure to once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: May 31, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Aged =18 years at the time of signing informed consent;

2. Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;

3. Have documented history of symptomatic GERD;

4. Have no mucosal break(s) on the upper GI endoscopy performed during Screening;

5. Have reported heartburn on =4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;

6. Able to understand and comply with the protocol requirements;

7. Willing and able to provide written informed consent at Screening;

8. 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.

9. 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.

10. 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. Diagnosed with erosive gastroesophageal reflux disease, acute upper GI bleeding, gastric ulcer or duodenal ulcer, or acute gastritis within 2 months prior to the upper GI endoscopy;

4. 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;

5. History or suspicion of functional upper gastrointestinal disorders, such as:

• Functional heartburn, as described in the Rome IV criteria, or

• Functional dyspepsia, as described in the Rome IV criteria.

6. History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease, or documented history of delayed gastric emptying;

7. History of acid-suppressive, esophageal, or gastric surgery;

o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.

8. 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.

9. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;

10. 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.

11. 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.

12. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;

13. Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;

14. Use of 2 or more commercial doses of reflux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, prokinetics, and antacids) within 1 week prior to the upper GI endoscopy at Screening;

15. 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.

16. 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;

17. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;

18. Positive test result for H. pylori at Screening or diagnosis and treatment of H. pylori within 4 to 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.

19. 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; or

• Serum magnesium <lower limit of normal.

20. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);

21. Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;

22. Involvement in another clinical study within 4 weeks of initiation of study drug; or

23. 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 .

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• BLI5100
Orally via tablet
• Placebo
Orally via tablet

Locations

Country	Name	City	State
United States	Research Site 51	Arcadia	California
United States	Research Site 112	Aurora	Colorado
United States	Research Site 126	Bakersfield	California
United States	Research Site 115	Beaumont	Texas
United States	Research Site 66	Bell Gardens	California
United States	Research Site 100	Bellaire	Texas
United States	Research Site 74	Boca Raton	Florida
United States	Research Site 35	Brooklyn	New York
United States	Research Site 19	Canoga Park	California
United States	Research Site 77	Chesapeake	Virginia
United States	Research Site 111	Chesterfield	Missouri
United States	Research Site 93	Chesterfield	Michigan
United States	Research Site 94	Chula Vista	California
United States	Research Site 137	Columbia	Missouri
United States	Research Site 20	Columbus	Ohio
United States	Research Site 88	Columbus	Ohio
United States	Research Site 108	Cooper City	Florida
United States	Research Site 125	Covington	Louisiana
United States	Research Site 98	Dallas	Texas
United States	Research Site 91	Doral	Florida
United States	Research Site 102	Downers Grove	Illinois
United States	Research Site 129	Englewood	New Jersey
United States	Research Site 75	Fayetteville	North Carolina
United States	Research Site 99	Forney	Texas
United States	Research Site 130	Freehold	New Jersey
United States	Research Site 07	Great Neck	New York
United States	Research Site 01	Gurnee	Illinois
United States	Research Site 28	Hartsdale	New York
United States	Research Site 128	Hermitage	Tennessee
United States	Research Site 03	Hialeah	Florida
United States	Research Site 78	Homestead	Florida
United States	Research Site 45	Houma	Louisiana
United States	Research Site 10	Huntington Park	California
United States	Research Site 24	Huntsville	Alabama
United States	Research Site 101	Idaho Falls	Idaho
United States	Research Site 131	Jackson	New Jersey
United States	Research Site 68	Katy	Texas
United States	Research Site 114	Kingsport	Tennessee
United States	Research Site 55	La Mesa	California
United States	Research Site 09	Lake City	Florida
United States	Research Site 06	Las Vegas	Nevada
United States	Research Site 127	Las Vegas	Nevada
United States	Research Site 73	Las Vegas	Nevada
United States	Research Site 29	Lewisville	Texas
United States	Research Site 87	Little Rock	Arkansas
United States	Research Site 89	Littleton	Colorado
United States	Research Site 120	Long Beach	California
United States	Research Site 54	Los Angeles	California
United States	Research Site 72	Los Angeles	California
United States	Research Site 23	Maitland	Florida
United States	Research Site 04	Marietta	Georgia
United States	Research Site 12	Marrero	Louisiana
United States	Research Site 109	Mentor	Ohio
United States	Research Site 124	Metairie	Louisiana
United States	Research Site 48	Metairie	Louisiana
United States	Research Site 31	Miami	Florida
United States	Research Site 38	Miami	Florida
United States	Research Site 43	Miami	Florida
United States	Research Site 67	Miami	Florida
United States	Research Site 71	Miami	Florida
United States	Research Site 81	Miami	Florida
United States	Research Site 92	Miami	Florida
United States	Research Site 42	Miami Lakes	Florida
United States	Research Site 18	Mission Viejo	California
United States	Research Site 97	Morgantown	West Virginia
United States	Research Site 69	Mount Airy	North Carolina
United States	Research Site 103	Nashville	Tennessee
United States	Research Site 60	Nashville	Tennessee
United States	Research Site 34	New Orleans	Louisiana
United States	Research Site 17	New Port Richey	Florida
United States	Research Site 49	New York	New York
United States	Research Site 58	New York	New York
United States	Research Site 61	North Charleston	South Carolina
United States	Research Site 117	North Little Rock	Arkansas
United States	Research Site 113	Northbrook	Illinois
United States	Research Site 02	Oak Lawn	Illinois
United States	Research Site 90	Ocoee	Florida
United States	Research Site 105	Ogden	Utah
United States	Research Site 107	Orlando	Florida
United States	Research Site 05	Palmetto Bay	Florida
United States	Research Site 32	Pearland	Texas
United States	Research Site 132	Peoria	Arizona
United States	Research Site 62	Phoenix	Arizona
United States	Research Site 30	Red Oak	Texas
United States	Research Site 64	Reno	Nevada
United States	Research Site 136	Richmond	Virginia
United States	Research Site 40	Rochester	New York
United States	Research Site 95	Saint Petersburg	Florida
United States	Research Site 116	Salisbury	North Carolina
United States	Research Site 106	Salt Lake City	Utah
United States	Research Site 57	Salt Lake City	Utah
United States	Research Site 21	San Antonio	Texas
United States	Research Site 22	San Antonio	Texas
United States	Research Site 26	San Antonio	Texas
United States	Research Site 14	San Diego	California
United States	Research Site 65	Sandy	Utah
United States	Research Site 59	Sandy Springs	Georgia
United States	Research Site 13	Santa Ana	California
United States	Research Site 85	Santa Ana	California
United States	Research Site 41	Santa Maria	California
United States	Research Site 50	Shelbyville	Tennessee
United States	Research Site 135	South Bend	Indiana
United States	Research Site 16	South Ogden	Utah
United States	Research Site 118	Springboro	Ohio
United States	Research Site 11	Sunrise	Florida
United States	Research Site 80	Tomball	Texas
United States	Research Site 27	Tucson	Arizona
United States	Research Site 46	Viera	Florida
United States	Research Site 134	Waco	Texas
United States	Research Site 25	West Monroe	Louisiana
United States	Research Site 110	Westlake	Ohio
United States	Research Site 121	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of 24-hour heartburn-free days		4 Weeks
Secondary	Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation)		4 Weeks