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NCT05587309 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis

A Phase 3 study, sponsored by Braintree Laboratories.

Completed
Registry status
Phase 3
Development phase
1,250
Enrollment target

NCT05587309: Completed Phase 3 study, sponsored by Braintree Laboratories.

NCT05587309 is a Phase 3 study that has completed, run by Braintree Laboratories. The registered enrollment target is 1,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05587309, a Phase 3 study, has completed, sponsored by Braintree Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
1,250 participants
Enrollment target

Study Summary

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 PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.

Interventions

  • DRUG BLI5100
  • DRUG PPI Control

Trial Details

FieldValue
Enrollment Target 1,250 participants
Start Date 2022-10-30
Est. Completion 2025-06-16
Phase Phase 3
Braintree Laboratories

49 total trials

What the finished NCT05587309 record still lists

NCT05587309 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher).

The record links to 0 conditions, and to 2 interventions - of which BLI5100 is the first listed.

NCT05587309 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05587309 about?

NCT05587309 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis". 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 PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once dail...

What is the current status of trial NCT05587309?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2022-10-30. Estimated completion is 2025-06-16.

What interventions are being tested in trial NCT05587309?

The interventions under investigation include: BLI5100 (DRUG), PPI Control (DRUG).

Who is sponsoring clinical trial NCT05587309?

This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05587309's enrollment target sits among peer trials

1,250 207th of 2000 higher than 1,791 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05587309, the US trial registry maintained by the National Library of Medicine. NCT05587309 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.