BLI5100 for Erosive Esophagitis

No longer recruiting at 133 trial locations

Overseen By Leah Hollins

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Braintree Laboratories

Must not be taking: Antipsychotics, Antidepressants, Anxiolytics, others

Disqualifiers: Esophageal stricture, Barrett's esophagus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 4 6}

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

I have had heartburn and regurgitation in the past week.

Exclusion Criteria

History of Malignancy in the past 5 years(with the exception of resected basal cell or squamous cell carcinoma)

History of eosinophilic esophagitis, achalasia, or other primary esophageal motility disorder; functional heartburn; or physiochemical trauma

History of alcoholism or substance abuse in 12 months prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks

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

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Maintenance Phase - BLI5100 Low Dose Experimental Treatment 1 Intervention

During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.

Group II: Maintenance Phase - BLI5100 High Dose Experimental Treatment 1 Intervention

During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.

Group III: Healing Phase - BLI5100 Experimental Treatment 1 Intervention

During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.

Group IV: Healing Phase - PPI Control Active Control 1 Intervention

During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.

Group V: Maintenance Phase - PPI Control Active Control 1 Intervention

During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.

Who Is Running the Clinical Trial?

Braintree Laboratories

Lead Sponsor

Trials

49

Recruited

13,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05890001

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-esophagitis

A 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-esophagitis

A 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 ...

4. sebelapharma.com sebelapharma.com/bli5100-gerd-and-nerd

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).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05587322

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-disease

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 non-erosive ...