BLI5100 for Erosive Esophagitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral medication, BLI5100, to determine if it can safely and effectively heal and maintain healing in people with erosive esophagitis (EE), a condition where stomach acid inflames and damages the esophagus. The study compares BLI5100 to a commonly used treatment, a proton pump inhibitor (PPI), in two phases: an 8-week healing phase and a 24-week maintenance phase. Individuals who have recently experienced heartburn and regurgitation and have been diagnosed with EE through endoscopy may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you stop using any gastric acid-suppressive agents, including PPIs, within 2 weeks before the screening endoscopy. Additionally, you should not use 2 or more doses of reflux esophagitis-related medications within 1 week before the screening. Persistent use of NSAIDs is not allowed, but low-dose aspirin is permitted if used before the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BLI5100 has undergone safety testing in several studies. For example, some studies have examined the safety of taking BLI5100 daily for up to a year, aiming to determine its long-term safety. Although detailed results are not provided here, the ongoing long-term studies suggest that BLI5100 is generally considered safe enough for continued research.
Additionally, two studies are currently testing BLI5100 in individuals with erosive esophagitis and non-erosive reflux disease. At this stage, researchers are assessing both the safety and effectiveness of the treatment. This indicates that earlier studies have already demonstrated BLI5100 to be reasonably safe for individuals.
In summary, while specific information on side effects or adverse events is not available here, ongoing research and past studies suggest that BLI5100 is generally well-tolerated.12345Why do researchers think this study treatment might be promising for erosive esophagitis?
Researchers are excited about BLI5100 because it represents a potentially groundbreaking approach to treating erosive esophagitis. Unlike standard treatments like proton pump inhibitors (PPIs), which primarily reduce stomach acid production, BLI5100 might offer a novel mechanism of action that targets the underlying causes of esophageal erosion more directly. Additionally, BLI5100 is being tested in both low and high doses during a maintenance phase, which could provide more tailored options for long-term management of the condition. If successful, BLI5100 could offer patients more effective relief with fewer side effects than current therapies.
What evidence suggests that this trial's treatments could be effective for erosive esophagitis?
Research shows that BLI5100 is being tested in this trial to evaluate its effectiveness in treating erosive esophagitis (EE), a condition that damages the esophagus. Earlier studies indicated that BLI5100 helped heal EE when taken once daily for 8 weeks. In this trial, participants in one arm will receive BLI5100 during the Healing Phase. Researchers are also examining whether BLI5100 can maintain esophageal health over the long term by testing both low and high doses for 24 weeks in separate arms during the Maintenance Phase. The aim is to determine if it can sustain healing after the initial treatment. These studies are crucial to confirm the potential benefits and safety of BLI5100 for individuals with EE.12346
Who Is on the Research Team?
Leah Hollins
Principal Investigator
Braintree Laboratories / Sebela Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with recent symptoms of heartburn and regurgitation, diagnosed with Erosive Esophagitis (EE) grades A to D. Participants must be able to consent and follow the study plan. Women should either be non-childbearing or agree to use birth control; men must also agree to use contraception and not donate sperm during the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Healing Phase
Participants receive once daily oral administration of BLI5100 or PPI control for up to 8 weeks to evaluate safety and efficacy in healing erosive esophagitis
Maintenance Phase
Participants receive once daily oral administration of BLI5100 (low or high dose) or PPI control for 24 weeks to evaluate safety and efficacy in maintaining healed erosive esophagitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BLI5100
- PPI Control
Trial Overview
The trial is testing BLI5100 against a standard Proton Pump Inhibitor (PPI) for healing EE over 8 weeks, then maintaining healed EE over 24 weeks. Patients will take oral doses daily, comparing BLI5100's effectiveness and safety with PPI control.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Braintree Laboratories
Lead Sponsor
Citations
A Study to Evaluate the Long-Term Safety of BLI5100 in ...
The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-bli5100-in-patients-with-erosive-esophagitisA Study to Evaluate the Efficacy and Safety of BLI5100 in ...
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 ...
3.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05587309/a-study-to-evaluate-the-efficacy-and-safety-of-bli5100-in-patients-with-erosive-esophagitisA Study to Evaluate the Efficacy and Safety of BLI5100 ...
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 ...
BLI5100 – GERD (EE and NERD)
Two Phase 3 studies are underway to evaluate the safety and efficacy of BLI5100 in patients with erosive esophagitis (EE) and non-erosive reflux disease (NERD).
NCT05587322 | A Study to Evaluate the Efficacy and ...
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, ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-long-term-safety-of-bli5100-in-patients-with-gastroesophageal-reflux-diseaseA Study to Evaluate the Long-Term Safety of BLI5100 in ...
The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive ...
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