BLI5100 for Erosive Esophagitis

Recruiting at 131 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

1250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests BLI5100, an oral medication, in patients with Erosive Esophagitis (EE). It aims to see if BLI5100 can heal the esophagus and maintain its healing.

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.

What data supports the effectiveness of the drug BLI5100 for treating erosive esophagitis?

Proton pump inhibitors (PPIs), which are similar to BLI5100, are known to be highly effective in healing erosive esophagitis by reducing stomach acid. Studies show that PPIs are better than other treatments like antacids and H2-receptor antagonists for both short-term and long-term relief. ^{1 2 3 4 5}

Is BLI5100 safe for humans?

Most studies on short- and long-term use of proton pump inhibitors (PPIs), like BLI5100, have shown reassuring safety data, but there are some reports of potential side effects or interactions with other drugs. ^{1 2 4 6 7}

How does the drug BLI5100 differ from other treatments for erosive esophagitis?

BLI5100 is being studied as a potential treatment for erosive esophagitis, which is often treated with proton-pump inhibitors (PPIs). Some patients do not respond well to PPIs, and alternative treatments like vonoprazan, a potassium-competitive acid blocker, are being explored. BLI5100 may offer a new option for those who are resistant to standard PPI therapy. ^{4 6 7 8 9}

Research Team

Leah Hollins

Principal Investigator

Braintree Laboratories / Sebela Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Short and long-term PPI treatment for GERD. Do we need more-potent anti-secretory drugs? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of four proton pump inhibitors for the short-term treatment of esophagitis in elderly patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A review of the clinical and economic impact of using esomeprazole or lansoprazole for the treatment of erosive esophagitis. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

Novel physiologic nomogram discriminates symptom outcome in patients with erosive esophagitis. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Proton pump inhibitors in acute healing and maintenance of erosive or worse esophagitis: a systematic overview. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind study to evaluate the acid-inhibitory effect of vonoprazan (20 mg and 40 mg) in patients with proton-pump inhibitor-resistant erosive esophagitis. [2020]

7. China pubmed.ncbi.nlm.nih.gov

[Role of esophageal motility abnormalities in severe reflux esophagitis]. [2014]

8. India pubmed.ncbi.nlm.nih.gov

Vonoprazan versus lansoprazole in erosive esophagitis - A systematic review and meta-analysis of randomized controlled trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness and acceptability of the FDA-licensed proton pump inhibitors for erosive esophagitis: A PRISMA-compliant network meta-analysis. [2022]