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

Sponsor
Braintree Laboratories (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05587322
Collaborator
(none)
633
Enrollment
72
Locations
3
Arms
20.8
Anticipated Duration (Months)
8.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 20 weeks of once daily oral administration of BLI5100 low dose and BLI5100 high dose in patients with NERD.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
633 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Jan 26, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: BLI5100 Low Dose

During the Treatment Period, patients will take BLI5100 low dose once daily, orally, for 4 weeks. During the Extension Period, patients will continue to take BLI5100 low dose once daily, orally, for 20 weeks.

Drug: BLI5100
Orally via tablet
Experimental: BLI5100 High Dose

During the Treatment Period, patients will take BLI5100 high dose once daily, orally, for 4 weeks. During the Extension Period, patients will continue to take BLI5100 high dose once daily, orally, for 20 weeks.

Drug: BLI5100
Orally via tablet
Placebo Comparator: Placebo

During the Treatment Period, patients will take placebo once daily, orally, for 4 weeks. In the Extension Phase, patients who received placebo in the Treatment Phase will be re-randomized to receive either BLI5100 low dose or BLI5100 high dose to take once daily, orally, for 20 weeks.

Drug: Placebo
Orally via tablet

Outcome Measures

Primary Outcome Measures

  1. Percentage of 24-hour heartburn-free days [4 Weeks]

Secondary Outcome Measures

  1. Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) [4 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Aged ≥18 years at the time of signing informed consent;

  2. Have experienced heartburn (burning sensation, pain at posterior bony thorax) for at least 6 months prior to Screening;

  3. Have documented history of symptomatic GERD;

  4. Have no mucosal break(s) on the upper GI endoscopy performed during Screening;

  5. Have reported heartburn on ≥4 days during any consecutive 7-day period of the Screening Period as recorded in the eDiary;

  6. Able to understand and comply with the protocol requirements;

  7. Willing and able to provide written informed consent at Screening;

  8. Is a female of non-childbearing potential, ie, is either surgically sterile (ie, had a hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy ≥6 months before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for ≥12 months, and, for females <55 years of age, with follicle-stimulating hormone in the post-menopausal range at Screening, based on the central laboratory's ranges; or If a female of childbearing potential, agrees to use an acceptable form of birth control from the Screening Visit until 30 days after the last dose of study drug.

  9. 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.

  10. 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.

  1. 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;

  2. 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;

  3. 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.

  1. 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;

  2. History of acid-suppressive, esophageal, or gastric surgery;

o Note: This is not applicable to appendectomy, cholecystectomy, or endoscopic excision of benign tumor.

  1. 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.

  1. History of an allergic disease, or hypersensitivity or intolerance to the active ingredient or excipients of the study drug;

  2. 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;

o Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for >3 months prior to Screening.

  1. Presence of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder;

  2. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for >6 months prior to Screening;

  3. Use of any gastric acid-suppressive agents, including PPIs, within 2 weeks prior to the upper GI endoscopy at Screening;

  4. 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;

  5. 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.

  1. If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days after the last dose of study drug;

  2. Positive test result for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus at Screening;

  3. 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; or

  • Serum magnesium <lower limit of normal.

  1. Abnormal ECG of clinical significance (eg, major arrhythmia, multifocal premature ventricular contractions, or 2° atrioventricular block anomaly);

  2. Presence of any gastric acid hypersecretory conditions, such as Zollinger-Ellison syndrome;

  3. Involvement in another clinical study within 4 weeks of initiation of study drug; or

  4. 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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site 24 Huntsville Alabama United States 35801
2 Research Site 62 Phoenix Arizona United States 85018
3 Research Site 87 Little Rock Arkansas United States 72211
4 Research Site 51 Arcadia California United States 91006
5 Research Site 66 Bell Gardens California United States 90201
6 Research Site 19 Canoga Park California United States 91304
7 Research Site 94 Chula Vista California United States 91910
8 Research Site 10 Huntington Park California United States 90255
9 Research Site 55 La Mesa California United States 91942
10 Research Site 72 Los Angeles California United States 90017
11 Research Site 54 Los Angeles California United States 90057
12 Research Site 18 Mission Viejo California United States 92691
13 Research Site 14 San Diego California United States 92120
14 Research Site 85 Santa Ana California United States 92703
15 Research Site 13 Santa Ana California United States 92704
16 Research Site 41 Santa Maria California United States 93458
17 Research Site 91 Doral Florida United States 33172
18 Research Site 03 Hialeah Florida United States 33013
19 Research Site 78 Homestead Florida United States 33030
20 Research Site 09 Lake City Florida United States 32055
21 Research Site 23 Maitland Florida United States 32751
22 Research Site 42 Miami Lakes Florida United States 33014
23 Research Site 38 Miami Florida United States 33134
24 Research Site 43 Miami Florida United States 33136
25 Research Site 67 Miami Florida United States 33155
26 Research Site 31 Miami Florida United States 33185
27 Research Site 71 Miami Florida United States 33186
28 Research Site 17 New Port Richey Florida United States 34653
29 Research Site 90 Ocoee Florida United States 34761
30 Research Site 05 Palmetto Bay Florida United States 33157
31 Research Site 95 Saint Petersburg Florida United States 33709
32 Research Site 11 Sunrise Florida United States 33351
33 Research Site 46 Viera Florida United States 32940
34 Research Site 04 Marietta Georgia United States 30060
35 Research Site 59 Sandy Springs Georgia United States 30328
36 Research Site 101 Idaho Falls Idaho United States 83404
37 Research Site 102 Downers Grove Illinois United States 60515
38 Research Site 02 Oak Lawn Illinois United States 60453
39 Research Site 45 Houma Louisiana United States 70363
40 Research Site 12 Marrero Louisiana United States 70072
41 Research Site 48 Metairie Louisiana United States 70006
42 Research Site 34 New Orleans Louisiana United States 70127
43 Research Site 25 West Monroe Louisiana United States 71291
44 Research Site 93 Chesterfield Michigan United States 48047
45 Research Site 06 Las Vegas Nevada United States 89106
46 Research Site 73 Las Vegas Nevada United States 89109
47 Research Site 64 Reno Nevada United States 89511
48 Research Site 35 Brooklyn New York United States 11235
49 Research Site 07 Great Neck New York United States 11023
50 Research Site 28 Hartsdale New York United States 10530
51 Research Site 49 New York New York United States 10033
52 Research Site 40 Rochester New York United States 14609
53 Research Site 75 Fayetteville North Carolina United States 28304
54 Research Site 69 Mount Airy North Carolina United States 27030
55 Research Site 20 Columbus Ohio United States 43213
56 Research Site 88 Columbus Ohio United States 43215
57 Research Site 60 Nashville Tennessee United States 37203
58 Research Site 50 Shelbyville Tennessee United States 37160
59 Research Site 100 Bellaire Texas United States 77401
60 Research Site 98 Dallas Texas United States 75230
61 Research Site 99 Forney Texas United States 75126
62 Research Site 68 Katy Texas United States 77494
63 Research Site 29 Lewisville Texas United States 75057
64 Research Site 32 Pearland Texas United States 77584
65 Research Site 30 Red Oak Texas United States 75154
66 Research Site 22 San Antonio Texas United States 78209
67 Research Site 26 San Antonio Texas United States 78229
68 Research Site 21 San Antonio Texas United States 78249
69 Research Site 57 Salt Lake City Utah United States 84107
70 Research Site 65 Sandy Utah United States 84092
71 Research Site 16 South Ogden Utah United States 84405
72 Research Site 01 Kenosha Wisconsin United States 53144

Sponsors and Collaborators

  • Braintree Laboratories

Investigators

  • Study Director: Leah Hollins, Braintree Laboratories / Sebela Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT05587322
Other Study ID Numbers:
  • BLI5100-302
First Posted:
Oct 20, 2022
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroesophageal Reflux

Study Results

No Results Posted as of Jan 25, 2023