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NCT05634746 · ClinicalTrials.gov registry record · Phase 3
24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)
A Phase 3 study, sponsored by Ellodi Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT05634746: Completed Phase 3 study, sponsored by Ellodi Pharmaceuticals.
NCT05634746 is a Phase 3 study that has completed, run by Ellodi Pharmaceuticals. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05634746, a Phase 3 study, has completed, sponsored by Ellodi Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
Study Summary
This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.
Primary Outcome
To evaluate the percentage of subjects with histological remission (defined ≤ 6 peak eosinophils \[eos\]/high power field \[HPF\] on esophageal mucosal biopsies at Week 24). 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
- PROCEDURE Esophagogastroduodenoscopy
- DRUG Placebo oral tablet
- DRUG APT-1011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2022-12-29 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 3 |
What the finished NCT05634746 record still lists
NCT05634746 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Esophagogastroduodenoscopy is the first listed.
NCT05634746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05634746 about?
NCT05634746 is a clinical study titled "24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)". This is a 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at b...
What is the current status of trial NCT05634746?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2022-12-29. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT05634746?
The interventions under investigation include: Esophagogastroduodenoscopy (PROCEDURE), Placebo oral tablet (DRUG), APT-1011 (DRUG).
Who is sponsoring clinical trial NCT05634746?
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 NCT05634746's enrollment target sits among peer trials
218 1331st of 2000 higher than 669 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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