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

Erosive Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05890001
• Other study ID #: BLI5100-303
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 5, 2023
• Est. completion date: September 30, 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 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis
• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

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

Locations

Country	Name	City	State
United States	Research Site 100	Bellaire	Texas
United States	Research Site 35	Brooklyn	New York
United States	Research Site 111	Chesterfield	Missouri
United States	Research Site 94	Chula Vista	California
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 98	Dallas	Texas
United States	Research Site 91	Doral	Florida
United States	Research Site 75	Fayetteville	North Carolina
United States	Research Site 99	Forney	Texas
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 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 55	La Mesa	California
United States	Research Site 06	Las Vegas	Nevada
United States	Research Site 29	Lewisville	Texas
United States	Research Site 87	Little Rock	Arkansas
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 12	Marrero	Louisiana
United States	Research Site 109	Mentor	Ohio
United States	Research Site 48	Metairie	Louisiana
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 92	Miami	Florida
United States	Research Site 42	Miami Lakes	Florida
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 117	North Little Rock	Arkansas
United States	Research Site 02	Oak Lawn	Illinois
United States	Research Site 90	Ocoee	Florida
United States	Research Site 05	Palmetto Bay	Florida
United States	Research Site 32	Pearland	Texas
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 40	Rochester	New York
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 65	Sandy	Utah
United States	Research Site 59	Sandy Springs	Georgia
United States	Research Site 13	Santa Ana	California
United States	Research Site 41	Santa Maria	California
United States	Research Site 16	South Ogden	Utah
United States	Research Site 11	Sunrise	Florida
United States	Research Site 27	Tucson	Arizona
United States	Research Site 46	Viera	Florida
United States	Research Site 110	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment-emergent adverse events		31 Weeks