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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05587309
Other study ID # BLI5100-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 30, 2022
Est. completion date December 29, 2024

Study information

Verified date May 2024
Source Braintree Laboratories
Contact Leah Hollins
Phone 781-843-2202
Email studydirector@sebelapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1250
Est. completion date December 29, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Aged =18 years at the time of signing informed consent; 2. Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit; 3. Current evidence of EE of LA grades A to D based on an upper GI endoscopy; 4. Able to understand and comply with the protocol requirements; 5. Willing and able to provide written informed consent at Screening; 6. 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. 7. 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. 8. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug. Exclusion Criteria: 1. Unable to undergo an upper GI endoscopy; 2. 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. 3. 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; 4. 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; 5. History of a connective tissue disorder associated with GI symptoms (eg, scleroderma or systemic lupus erythematous) or inflammatory bowel disease; 6. History of acid-suppressive, esophageal, or gastric surgery; o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor. 7. 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. 8. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug; 9. 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. 10. 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. 11. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening; 12. Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening; 13. Use of 2 or more commercial doses of ref lux esophagitis-related medications (including H2 blockers, prostaglandins, mucosal protective agents, and prokinetics) within 1 week prior to the upper GI endoscopy at Screening; 14. Requirement of persistent 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. 15. 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; 16. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening; 17. Positive test result for H pylori at Screening or diagnosis and treatment of H pylori within 6 weeks prior to randomization; o Note: Patients who test positive for H pylori at Screening will be offered treatment according to local standard of care and may be re-screened for eligibility following completion of treatment. 18. Abnormal laboratory results with clinical relevance at Screening as follows: - Aspartate aminotransferase (AST), 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; or - Serum magnesium < lower limit of normal. 19. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly); 20. Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome; 21. Involvement in another clinical study within 4 weeks of initiation of study drug; 22. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BLI5100
Orally via tablet
PPI Control
Orally via tablet

Locations

Country Name City State
United States Research Site 157 Anderson South Carolina
United States Research Site 51 Arcadia California
United States Research Site 153 Atlanta Georgia
United States Research Site 112 Aurora Colorado
United States Research Site 126 Bakersfield California
United States Research Site 115 Beaumont Texas
United States Research Site 66 Bell Gardens California
United States Research Site 100 Bellaire Texas
United States Research Site 74 Boca Raton Florida
United States Research Site 151 Boise Idaho
United States Research Site 147 Bristol Connecticut
United States Research Site 35 Brooklyn New York
United States Research Site 156 Camarillo California
United States Research Site 19 Canoga Park California
United States Research Site 77 Chesapeake Virginia
United States Research Site 111 Chesterfield Missouri
United States Research Site 93 Chesterfield Michigan
United States Research Site 94 Chula Vista California
United States Research Site 137 Columbia Missouri
United States Research Site 146 Columbia South Carolina
United States Research Site 158 Columbus Ohio
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 125 Covington Louisiana
United States Research Site 98 Dallas Texas
United States Research Site 91 Doral Florida
United States Research Site 102 Downers Grove Illinois
United States Research Site 129 Englewood New Jersey
United States Research Site 75 Fayetteville North Carolina
United States Research Site 139 Florham Park New Jersey
United States Research Site 140 Flowood Mississippi
United States Research Site 99 Forney Texas
United States Research Site 130 Freehold New Jersey
United States Research Site 143 Glenview Illinois
United States Research Site 07 Great Neck New York
United States Research Site 01 Gurnee Illinois
United States Research Site 141 Gurnee Illinois
United States Research Site 28 Hartsdale New York
United States Research Site 159 Henderson Nevada
United States Research Site 128 Hermitage Tennessee
United States Research Site 03 Hialeah Florida
United States Research Site 155 High Point North Carolina
United States Research Site 78 Homestead Florida
United States Research Site 145 Homewood Alabama
United States Research Site 45 Houma Louisiana
United States Research Site 154 Houston Texas
United States Research Site 162 Houston Texas
United States Research Site 10 Huntington Park California
United States Research Site 24 Huntsville Alabama
United States Research Site 101 Idaho Falls Idaho
United States Research Site 131 Jackson New Jersey
United States Research Site 144 Jonesboro Arkansas
United States Research Site 138 Kansas City Missouri
United States Research Site 68 Katy Texas
United States Research Site 114 Kingsport Tennessee
United States Research Site 55 La Mesa California
United States Research Site 09 Lake City Florida
United States Research Site 06 Las Vegas Nevada
United States Research Site 127 Las Vegas Nevada
United States Research Site 160 Las Vegas Nevada
United States Research Site 163 Las Vegas Nevada
United States Research Site 73 Las Vegas Nevada
United States Research Site 29 Lewisville Texas
United States Research Site 87 Little Rock Arkansas
United States Research Site 89 Littleton Colorado
United States Research Site 120 Long Beach California
United States Research Site 72 Los Angeles California
United States Research Site 23 Maitland Florida
United States Research Site 04 Marietta Georgia
United States Research Site 12 Marrero Louisiana
United States Research Site 161 McAllen Texas
United States Research Site 109 Mentor Ohio
United States Research Site 124 Metairie Louisiana
United States Research Site 48 Metairie Louisiana
United States Research Site 31 Miami Florida
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 81 Miami Florida
United States Research Site 92 Miami Florida
United States Research Site 42 Miami Lakes Florida
United States Research Site 18 Mission Viejo California
United States Research Site 97 Morgantown West Virginia
United States Research Site 69 Mount Airy North Carolina
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 58 New York New York
United States Research Site 61 North Charleston South Carolina
United States Research Site 117 North Little Rock Arkansas
United States Research Site 113 Northbrook Illinois
United States Research Site 02 Oak Lawn Illinois
United States Research Site 90 Ocoee Florida
United States Research Site 105 Ogden Utah
United States Research Site 107 Orlando Florida
United States Research Site 05 Palmetto Bay Florida
United States Research Site 32 Pearland Texas
United States Research Site 132 Peoria Arizona
United States Research Site 150 Peoria Arizona
United States Research Site 62 Phoenix Arizona
United States Research Site 148 Plymouth Minnesota
United States Research Site 30 Red Oak Texas
United States Research Site 64 Reno Nevada
United States Research Site 136 Richmond Virginia
United States Research Site 40 Rochester New York
United States Research Site 95 Saint Petersburg Florida
United States Research Site 116 Salisbury North Carolina
United States Research Site 106 Salt Lake City Utah
United States Research Site 57 Salt Lake City Utah
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 14 San Diego California
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 85 Santa Ana California
United States Research Site 41 Santa Maria California
United States Research Site 50 Shelbyville Tennessee
United States Research Site 135 South Bend Indiana
United States Research Site 16 South Ogden Utah
United States Research Site 118 Springboro Ohio
United States Research Site 11 Sunrise Florida
United States Research Site 80 Tomball Texas
United States Research Site 27 Tucson Arizona
United States Research Site 152 Tulsa Oklahoma
United States Research Site 46 Viera Florida
United States Research Site 134 Waco Texas
United States Research Site 25 West Monroe Louisiana
United States Research Site 110 Westlake Ohio
United States Research Site 54 Westlake California
United States Research Site 121 Wichita Falls Texas

Sponsors (1)

Lead Sponsor Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing Phase: Percentage of patients with complete healing by Week 8. 8 Weeks
Primary Maintenance Phase: Percentage of patients who maintain complete healing through Week 24. 24 Weeks
Secondary Healing Phase: Percentage of 24-hour heartburn-free days through Week 8. 8 Weeks
Secondary Maintenance Phase: Percentage of 24-hour heartburn-free days through Week 24. 24 Weeks
See also
  Status Clinical Trial Phase
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Completed NCT01459367 - Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis Phase 3
Completed NCT00228527 - Esomeprazole for Treatment of GERD in Pediatric Patients Phase 4
Completed NCT01499368 - A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients Phase 3
Not yet recruiting NCT04613895 - Treatment Effect According to Timing of Administration of DWP14012 40 mg N/A
Recruiting NCT02615184 - A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children Phase 2
Completed NCT02456935 - Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis Phase 3
Completed NCT02028663 - Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis Phase 2
Completed NCT03006874 - Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis Phase 3
Completed NCT02388724 - Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis Phase 3
Completed NCT01865825 - Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)? N/A
Completed NCT02679508 - Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety Phase 4
Recruiting NCT06391177 - A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily Phase 1
Completed NCT05050188 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008 Phase 1
Completed NCT01874535 - Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy Phase 4
Completed NCT00206180 - NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Phase 4
Completed NCT01642615 - Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents Phase 2
Completed NCT01630746 - A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis Phase 3
Completed NCT01509261 - Efficacy Study of Ilaprazole to Treat Erosive Esophgitis Phase 3