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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 is a Phase 3 study that has completed, run by Ellodi Pharmaceuticals. The registered enrollment target is 218 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05634746
The ClinicalTrials.gov registry entry for NCT05634746 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ellodi Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Esophagogastroduodenoscopy is the first listed.
NCT05634746 reports 0 study locations.
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.
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