Clinical trial NCT05890001: A Study to Evaluate the Long-Term Safety of BLI5100 in Patients with Gastroesophageal Reflux Disease
Official title: A Study to Evaluate the Long-Term Safety of BLI5100 in Patients with Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Reflux Disease
Erosive Esophagitis
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of treatment-emergent adverse events
timeFrame: 31 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site 24
state: Alabama
city: Phoenix
country: United States
facility: Research Site 62
state: Arizona
city: Tucson
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facility: Research Site 27
state: Arizona
city: Little Rock
country: United States
facility: Research Site 87
state: Arkansas
city: North Little Rock
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facility: Research Site 117
state: Arkansas
city: Chula Vista
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facility: Research Site 94
state: California
city: Huntington Park
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facility: Research Site 10
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facility: Research Site 55
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city: Los Angeles
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facility: Research Site 72
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facility: Research Site 54
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city: Santa Maria
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facility: Research Site 41
state: California
city: Cooper City
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facility: Research Site 108
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city: Doral
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facility: Research Site 91
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city: Homestead
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facility: Research Site 78
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city: Maitland
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facility: Research Site 23
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city: Miami Lakes
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facility: Research Site 42
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city: Miami
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facility: Research Site 38
state: Florida
city: Miami
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facility: Research Site 43
state: Florida
city: Miami
country: United States
facility: Research Site 67
state: Florida
city: Miami
country: United States
facility: Research Site 92
state: Florida
city: Miami
country: United States
facility: Research Site 71
state: Florida
city: New Port Richey
country: United States
facility: Research Site 17
state: Florida
city: Ocoee
country: United States
facility: Research Site 90
state: Florida
city: Palmetto Bay
country: United States
facility: Research Site 05
state: Florida
city: Sunrise
country: United States
facility: Research Site 11
state: Florida
city: Viera
country: United States
facility: Research Site 46
state: Florida
city: Sandy Springs
country: United States
facility: Research Site 59
state: Georgia
city: Gurnee
country: United States
facility: Research Site 01
state: Illinois
city: Oaklawn
country: United States
facility: Research Site 02
state: Illinois
city: Houma
country: United States
facility: Research Site 45
state: Louisiana
city: Marrero
country: United States
facility: Research Site 12
state: Louisiana
city: Metairie
country: United States
facility: Research Site 48
state: Louisiana
city: New Orleans
country: United States
facility: Research Site 34
state: Louisiana
city: Chesterfield
country: United States
facility: Research Site 111
state: Missouri
city: Las Vegas
country: United States
facility: Research Site 06
state: Nevada
city: Reno
country: United States
facility: Research Site 64
state: Nevada
city: Brooklyn
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facility: Research Site 35
state: New York
city: Great Neck
country: United States
facility: Research Site 07
state: New York
city: Hartsdale
country: United States
facility: Research Site 28
state: New York
city: New York
country: United States
facility: Research Site 49
state: New York
city: Rochester
country: United States
facility: Research Site 40
state: New York
city: Fayetteville
country: United States
facility: Research Site 75
state: North Carolina
city: Columbus
country: United States
facility: Research Site 20
state: Ohio
city: Columbus
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facility: Research Site 88
state: Ohio
city: Mentor
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facility: Research Site 109
state: Ohio
city: Westlake
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facility: Research Site 110
state: Ohio
city: Nashville
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facility: Research Site 60
state: Tennessee
city: Nashville
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facility: Research Site 103
state: Tennessee
city: Bellaire
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facility: Research Site 100
state: Texas
city: Dallas
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facility: Research Site 98
state: Texas
city: Forney
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facility: Research Site 99
state: Texas
city: Lewisville
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facility: Research Site 29
state: Texas
city: Pearland
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facility: Research Site 32
state: Texas
city: Red Oak
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facility: Research Site 30
state: Texas
city: San Antonio
country: United States
facility: Research Site 22
state: Texas
city: San Antonio
country: United States
facility: Research Site 26
state: Texas
city: San Antonio
country: United States
facility: Research Site 21
state: Texas
city: Sandy
country: United States
facility: Research Site 65
state: Utah
city: South Ogden
country: United States
facility: Research Site 16
state: Utah
Study officials:
References: