A Phase 3, Double-Blind, Randomized, Two-Phase, Active-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis
Overview
- Phase
- Phase 3
- Intervention
- BLI5100
- Conditions
- Erosive Esophagitis
- Sponsor
- Braintree Laboratories
- Enrollment
- 1250
- Locations
- 122
- Primary Endpoint
- Healing Phase: Percentage of patients with complete healing by Week 8.
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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;
- •o Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
- •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;
- •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.
Arms & Interventions
Healing Phase - BLI5100
During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
Intervention: BLI5100
Healing Phase - PPI Control
During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
Intervention: PPI Control
Maintenance Phase - BLI5100 Low Dose
During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
Intervention: BLI5100
Maintenance Phase - BLI5100 High Dose
During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
Intervention: BLI5100
Maintenance Phase - PPI Control
During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.
Intervention: PPI Control
Outcomes
Primary Outcomes
Healing Phase: Percentage of patients with complete healing by Week 8.
Time Frame: 8 Weeks
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
Time Frame: 24 Weeks
Secondary Outcomes
- Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.(8 Weeks)
- Maintenance Phase: Percentage of 24-hour heartburn-free days through Week 24.(24 Weeks)