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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-erosive Reflux Disease

In brief

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.

Key facts

Study ID: NCT05587322
Run by: Braintree Laboratories
People needed: 800
Starts: 2022-09-06
Expected to finish: 2024-04-23
Last updated by the study team: 2024-07-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged ≥18 years at the time of signing informed consent;
Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;
Have documented history of symptomatic GERD;
Have no mucosal break(s) on the upper GI endoscopy performed during Screening;
Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;
Able to understand and comply with the protocol requirements;
Willing and able to provide written informed consent at Screening;
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.
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.

You may not qualify if…

Unable to undergo an upper GI endoscopy;
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.
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;
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;
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.
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;
History of acid-suppressive, esophageal, or gastric surgery;
o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.
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.
History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;
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.
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.
Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;
Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;
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;
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;

Where it is running

Research Site 132 — Peoria, Arizona, United States
Research Site 62 — Phoenix, Arizona, United States
Research Site 27 — Tucson, Arizona, United States
Research Site 87 — Little Rock, Arkansas, United States
Research Site 117 — North Little Rock, Arkansas, United States
Research Site 51 — Arcadia, California, United States
Research Site 126 — Bakersfield, California, United States
Research Site 66 — Bell Gardens, California, United States
Research Site 19 — Canoga Park, California, United States
Research Site 94 — Chula Vista, California, United States
Research Site 10 — Huntington Park, California, United States
Research Site 55 — La Mesa, California, United States
Research Site 120 — Long Beach, California, United States
Research Site 72 — Los Angeles, California, United States
Research Site 54 — Los Angeles, California, United States
Research Site 18 — Mission Viejo, California, United States
Research Site 14 — San Diego, California, United States
Research Site 85 — Santa Ana, California, United States
Research Site 13 — Santa Ana, California, United States
Research Site 41 — Santa Maria, California, United States
Research Site 112 — Aurora, Colorado, United States
Research Site 89 — Littleton, Colorado, United States
Research Site 74 — Boca Raton, Florida, United States
Research Site 108 — Cooper City, Florida, United States
Research Site 24 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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