Healing Phase - BLI5100 for Erosive Esophagitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site 49, New York, NYErosive EsophagitisBLI5100 - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
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Study Summary

This trial studies safety & efficacy of a drug (BLI5100) in healing & maintaining healed EE over 8 weeks & 24 weeks, respectively.

Eligible Conditions
  • Erosive Esophagitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 24 Weeks

24 Weeks
Heartburn
Maintenance Phase: Percentage of patients who maintain complete healing through Week 24.
8 Weeks
Healing Phase: Percentage of 24-hour heartburn-free days through Week 8.
Healing Phase: Percentage of patients with complete healing by Week 8.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

5 Treatment Groups

Healing Phase - PPI Control
1 of 5
Maintenance Phase - PPI Control
1 of 5
Healing Phase - BLI5100
1 of 5
Maintenance Phase - BLI5100 Low Dose
1 of 5
Maintenance Phase - BLI5100 High Dose
1 of 5

Active Control

Experimental Treatment

1250 Total Participants · 5 Treatment Groups

Primary Treatment: Healing Phase - BLI5100 · No Placebo Group · Phase 3

Healing Phase - BLI5100
Drug
Experimental Group · 1 Intervention: BLI5100 · Intervention Types: Drug
Maintenance Phase - BLI5100 Low Dose
Drug
Experimental Group · 1 Intervention: BLI5100 · Intervention Types: Drug
Maintenance Phase - BLI5100 High Dose
Drug
Experimental Group · 1 Intervention: BLI5100 · Intervention Types: Drug
Healing Phase - PPI Control
Drug
ActiveComparator Group · 1 Intervention: PPI Control · Intervention Types: Drug
Maintenance Phase - PPI Control
Drug
ActiveComparator Group · 1 Intervention: PPI Control · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Braintree LaboratoriesLead Sponsor
47 Previous Clinical Trials
11,735 Total Patients Enrolled
Leah HollinsStudy DirectorBraintree Laboratories / Sebela Pharmaceuticals
1 Previous Clinical Trials
633 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Are there any restrictions for who can join this clinical trial?

"We are looking for 1250 individuals aged 18-85 who have erosive esophagitis and meet the following criteria:-Have experienced heartburn and regurgitation within the last 7 days-Able to understand and comply with the protocol requirements-Aged ≥18 years old and able to provide written informed consent-If female, must be of non-childbearing potential or willing to use an acceptable form of birth control-If male, must be willing to use an acceptable form of birth control and abstain from sperm donation-Current evidence of EE of LA grades A to" - Anonymous Online Contributor

Unverified Answer

Do many North American clinics participate in this research?

"Currently, this study is being conducted at 26 different research sites, which are located in places such as Great Neck, Sunrise, and Palmetto Bay." - Anonymous Online Contributor

Unverified Answer

Does this research include individuals older than 25 years old?

"This study's age requirements state that patients must be at least 18 years old but no older than 85 in order to be eligible for participation." - Anonymous Online Contributor

Unverified Answer

Are investigators still signing up patients for this research?

"That is correct. The information available on clinicaltrials.gov tells us that this particular trial is ongoing and actively recruiting patients. This trial was first posted on November 30th, 2020 and was last updated on October 17th, 2020. They are looking for a total of 1250 participants from 26 different sites." - Anonymous Online Contributor

Unverified Answer

Has the FDA cleared Maintenance Phase - BLI5100 High Dose for use?

"Maintenance Phase - BLI5100 High Dose falls into the third and final stage of clinical trials. This means that while there is some efficacy data, there is also a considerable amount of safety data. As a result, our team has given it a score of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.