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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 is a Phase 3 study that has completed, run by Ellodi Pharmaceuticals. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05083312
The ClinicalTrials.gov registry entry for NCT05083312 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6 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 2 interventions - of which Placebo oral tablet is the first listed.
NCT05083312 reports 0 study locations.
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.
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