A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis (NCT05587309) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
United States1,250 participantsStarted 2022-10-30
Plain-language summary
The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥18 years at the time of signing informed consent;
✓. Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
✓. Current evidence of EE of LA grades A to D based on an upper GI endoscopy;
✓. 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.
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Healing Phase: Percentage of patients with complete healing by Week 8.
Timeframe: 8 Weeks
2
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
. 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 of eosinophilic esophagitis, achalasia, or other primary esophageal motility disorder; functional heartburn; physiochemical trauma (including radiation, mucosal resection, or cryotherapy); or documented history of delayed gastric emptying;
✕. History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease;
✕. History of acid-suppressive, esophageal, or gastric surgery;
✕. History of malignancy within the past 5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin);
✕. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;