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NCT05083312 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
A Phase 3 study, sponsored by Ellodi Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT05083312: Completed Phase 3 study, sponsored by Ellodi Pharmaceuticals.
NCT05083312 is a Phase 3 study that has completed, run by Ellodi Pharmaceuticals. The registered enrollment target is 6 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05083312, a Phase 3 study, has completed, sponsored by Ellodi Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE.
Primary Outcome
To compare the Week 12 histologic responder rates (≤ 6 peak eosinophils / high power field \[eos/HPF\]) for APT-1011 3 mg hora somni (HS) with that for placebo. HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens \[0.3 mm\^2\] and 22 mm ocular
Interventions
- DRUG Placebo oral tablet
- DRUG APT-1011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2022-09-05 |
| Phase | Phase 3 |
What the finished NCT05083312 record still lists
NCT05083312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT05083312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05083312 about?
NCT05083312 is a clinical study titled "Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial". This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to \<18 years) with EoE.
What is the current status of trial NCT05083312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2021-09-30. Estimated completion is 2022-09-05.
What interventions are being tested in trial NCT05083312?
The interventions under investigation include: Placebo oral tablet (DRUG), APT-1011 (DRUG).
Who is sponsoring clinical trial NCT05083312?
This trial is sponsored by Ellodi Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05083312's enrollment target sits among peer trials
6 1995th of 2000 higher than 4 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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