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Unknown

BLI5100 for Erosive Esophagitis

Verified Trial
Phase 3
Recruiting
Research Sponsored by Braintree Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, they may include typical reactions associated with gastrointestinal drugs such as digestive disturbances, potential allergic reactions or sensitivities related to the active ingredients or excipients in BLI5100.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had heartburn and regurgitation in the past week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Healing Phase: Percentage of patients with complete healing by Week 8.
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
Secondary study objectives
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.
Heartburn

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Phase - BLI5100 Low DoseExperimental Treatment1 Intervention
During the Maintenance Phase, patients will take BLI5100 low dose once daily, orally, for 24 weeks.
Group II: Maintenance Phase - BLI5100 High DoseExperimental Treatment1 Intervention
During the Maintenance Phase, patients will take BLI5100 high dose once daily, orally, for 24 weeks.
Group III: Healing Phase - BLI5100Experimental Treatment1 Intervention
During the Healing Phase, patients will take BLI5100 once daily, orally, for up to 8 weeks.
Group IV: Healing Phase - PPI ControlActive Control1 Intervention
During the Healing Phase, patients will take a PPI control once daily, orally, for up to 8 weeks.
Group V: Maintenance Phase - PPI ControlActive Control1 Intervention
During the Maintenance Phase, patients will take a PPI control once daily, orally, for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BLI5100
2022
Completed Phase 3
~800

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Braintree LaboratoriesLead Sponsor
48 Previous Clinical Trials
12,274 Total Patients Enrolled
1 Trials studying Erosive Esophagitis
400 Patients Enrolled for Erosive Esophagitis
Leah HollinsStudy DirectorBraintree Laboratories / Sebela Pharmaceuticals
1 Previous Clinical Trials
800 Total Patients Enrolled

Media Library

BLI5100 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05587309 — Phase 3
Erosive Esophagitis Research Study Groups: Healing Phase - BLI5100, Healing Phase - PPI Control, Maintenance Phase - BLI5100 Low Dose, Maintenance Phase - BLI5100 High Dose, Maintenance Phase - PPI Control
Erosive Esophagitis Clinical Trial 2023: BLI5100 Highlights & Side Effects. Trial Name: NCT05587309 — Phase 3
BLI5100 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587309 — Phase 3
~417 spots leftby Nov 2025
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