BLI5100 for Acid Reflux

No longer recruiting at 114 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

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

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the new drug BLI5100, a potential treatment for acid reflux, in people with non-erosive reflux disease (NERD), a type of acid reflux that doesn't visibly damage the esophagus. Participants will take either a low dose, high dose, or placebo for a set period to evaluate the drug's efficacy and safety for extended use. The trial may suit those who have experienced a burning sensation or pain from heartburn for at least six months and have a history of GERD symptoms without visible esophagus damage. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using gastric acid-suppressive agents, including PPIs, within 2 weeks before the screening endoscopy. You also need to avoid using two or more doses of reflux-related medications like H2 blockers and antacids within 1 week before the screening. If you're on a stable dose of certain medications like prescribed opioids or psychiatric medications, you may continue them if they meet specific criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BLI5100 is being tested in individuals with conditions like non-erosive reflux disease (NERD) and erosive esophagitis (EE). These studies assess the safety of BLI5100 over time by testing both low and high doses.

Safety information from these studies indicates that researchers are closely monitoring any side effects of BLI5100. Since BLI5100 is in a Phase 3 trial, earlier studies have generally found it safe for patients. However, like any medication, side effects can occur, and these are being carefully monitored.

While specific details about side effects aren't available, BLI5100 reaching this stage of testing is a positive sign for its safety in humans. Prospective participants should consult a healthcare provider to understand any possible risks and benefits before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BLI5100 for acid reflux because it offers a novel approach compared to standard treatments like proton pump inhibitors (PPIs) and H2 blockers. Unlike these traditional options, which reduce stomach acid, BLI5100 is designed to potentially provide more targeted relief by modulating the acid production mechanism more precisely. Additionally, the availability of both high and low doses in treatment suggests a customizable approach that might better suit individual patient needs, leading to more effective management of symptoms. This innovative strategy could transform how we address and alleviate acid reflux symptoms.

What evidence suggests that this trial's treatments could be effective for acid reflux?

Research shows that BLI5100 is under investigation for its potential to help with non-erosive reflux disease (NERD). Earlier studies found BLI5100 to be safe when taken daily for up to a year. In this trial, participants will receive either a low or high dose of BLI5100 to assess its effectiveness in reducing acid reflux symptoms. Although limited information exists on its effectiveness in humans, ongoing research aims to demonstrate its potential to relieve symptoms like heartburn, both during the day and at night. Early studies are promising, but more data is needed to confirm its efficacy for NERD. ^{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 Non-erosive Reflux Disease (NERD) who've had heartburn for at least 6 months, no esophageal damage on endoscopy, and not using certain medications. Men must use birth control or abstain from sperm donation for 3 months post-trial; women must be non-childbearing or use birth control.

Inclusion Criteria

Willing and able to provide written informed consent at Screening;

I am either not able to have children or will use birth control during the study.

I have a history of severe acid reflux.

Exclusion Criteria

I haven't taken any acid-reducing medication in the last 2 weeks.

I must continue taking NSAIDs throughout the study.

You have a history of allergic reactions or are intolerant to the active ingredient or other ingredients in the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BLI5100 low dose, BLI5100 high dose, or placebo once daily for 8 weeks

8 weeks

Extension

Participants continue to receive BLI5100 low dose or high dose once daily for 20 weeks

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BLI5100
• Placebo

Trial Overview The trial tests BLI5100's safety and effectiveness in treating NERD over four weeks compared to a placebo. Participants will receive either a low dose, high dose of BLI5100, or a placebo once daily. There's also an extension phase to assess long-term safety.

How Is the Trial Designed?

Group I: BLI5100 Low Dose Experimental Treatment 1 Intervention

During the Treatment Period, patients will take BLI5100 low dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 low dose once daily, orally, for 20 weeks.

Group II: BLI5100 High Dose Experimental Treatment 1 Intervention

During the Treatment Period, patients will take BLI5100 high dose once daily, orally, for 8 weeks. During the Extension Period, patients will continue to take BLI5100 high dose once daily, orally, for 20 weeks.

Group III: Placebo Placebo Group 1 Intervention

During the Treatment Period, patients will take placebo once daily, orally, for 8 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.

Who Is Running the Clinical Trial?

Braintree Laboratories

Lead Sponsor

Trials

49

Recruited

13,500+

Published Research Related to This Trial

In a study of 214 patients with non-erosive gastro-oesophageal reflux disease (GERD), lansoprazole significantly reduced daytime and night-time heartburn compared to placebo, showing effectiveness from the first day of treatment.

Patients taking lansoprazole experienced fewer days and nights with heartburn and less need for antacids over the 8-week treatment period, with a similar safety profile to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lansoprazole in the treatment of heartburn in patients without erosive oesophagitis. Richter, JE., Kovacs, TO., Greski-Rose, PA., et al.[2019]

In a double-blind study involving 32 patients with chronic heartburn, both liquid antacid and placebo showed significant improvements in the frequency and severity of heartburn, indicating that the natural history of reflux esophagitis tends to improve over time regardless of treatment.

There was no significant difference in the effectiveness of antacid compared to placebo in healing esophagitis or reducing painful episodes, suggesting that the perceived benefits of antacids may be due to a placebo effect rather than a direct therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind comparison of liquid antacid and placebo in the treatment of symptomatic reflux esophagitis. Graham, DY., Patterson, DJ.[2019]

In a meta-analysis of 14 randomized controlled trials involving 771 participants, proton pump inhibitor (PPI) therapy was found to significantly improve reflux symptoms in patients with laryngopharyngeal reflux (LPR) compared to placebo, with a risk difference of 0.15.

While PPI therapy improved the total reflux symptom index, it did not show any significant advantage over placebo in improving the reflux finding score, indicating that while symptoms may improve, some clinical findings may not reflect this change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitor Therapy for the Treatment of Laryngopharyngeal Reflux: A Meta-Analysis of Randomized Controlled Trials. Guo, H., Ma, H., Wang, J.[2016]

Citations

1. 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, ...

2. 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 ...

3. withpower.com withpower.com/trial/phase-3-gastroesophageal-reflux-8-2022-6ff32

BLI5100 for Acid Reflux · Info for Participants In a study of 214 patients with non-erosive gastro-oesophageal reflux disease (GERD), lansoprazole significantly reduced daytime and night-time heartburn ...

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. 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 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05587322/a-study-to-evaluate-the-efficacy-and-safety-of-bli5100-in-patients-with-non-erosive-reflux-disease

A Study to Evaluate the Efficacy and Safety of BLI5100 ... 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, BLI ...