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NCT04281108 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
A Phase 3 study of Eosinophilic Esophagitis, sponsored by Ellodi Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 143
- Enrollment target
- 20
- Study locations
NCT04281108: Completed Phase 3 study of Eosinophilic Esophagitis, sponsored by Ellodi Pharmaceuticals.
NCT04281108 is a Phase 3 study of Eosinophilic Esophagitis that has completed, run by Ellodi Pharmaceuticals. The registered enrollment target is 143 participants, below the 861-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04281108, a Phase 3 study of Eosinophilic Esophagitis, has completed, sponsored by Ellodi Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 143 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label extension (OLE) of APT-1011 in adults with EoE. Part A will evaluate the efficacy and safety of APT-1011 3 mg administered hora somni (HS; at bedtime) for the induction of response to treatment (histologic and symptomatic) over 12 weeks. Part B will evaluate histological relapse-free status in patients re-randomized to continue APT-1011 or placebo (active treatment withdrawal) until Week 52. Part C, the OLE, will continue until regulatory approval of APT-1011 or Sponsor termination of the study.
Primary Outcome
To compare the Week 12 histologic responder rates (≤ 6 peak eosinophils \[eos\]/high power field \[HPF\]) for APT-1011 3 mg 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
Conditions Studied
Interventions
- PROCEDURE Esophagogastroduodenoscopy
- DRUG Placebo oral tablet
- DRUG APT-1011
Study Locations (20)
California
- Camarillo Endoscopy Center - Camarillo
- Hope Clinical Research - Canoga Park
- Facey Medical Foundation - Mission Hills
- United Medical Doctors - Murrieta
- Medical Associates Research Group - San Diego
Florida
- Fleming Island Center for Clinical Research - Fleming Island
- Nature Coast Clinical Research - Inverness
- Encore Borland Groover Clinical Research - Jacksonville
- Endoscopic Research, Inc. - Orlando
Alabama
- Pinnacle Research Group, LLC - Anniston
- Gut P.C., dba; Digestive Health Specialists of the Southeast - Dothan
- East View Medical Research, LLC - Mobile
Colorado
- Asthma and Allergy Associates, PC - Colorado Springs
- Peak Gastroenterology Associates - Colorado Springs
- Western States Clinical Research Inc. - Wheat Ridge
Arkansas
- Preferred Research Partners Inc. - Little Rock
- Arkansas Gastroenterology - North Little Rock
Connecticut
- Western Connecticut Medical Group - Gastroenterology - Danbury
- Medical Research Center of Connecticut, LLC - Hamden
Arizona
- Del Sol Research Management, LLC - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2022-10-24 |
| Phase | Phase 3 |
What the finished NCT04281108 record still lists
NCT04281108 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 861-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 3 interventions - of which Esophagogastroduodenoscopy is the first listed.
NCT04281108 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT04281108 about?
NCT04281108 is a clinical study titled "Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)". This is a 2-part randomized, double-blind, placebo-controlled study followed by an open-label extension (OLE) of APT-1011 in adults with EoE. Part A will evaluate the efficacy and safety of APT-1011 3 mg administered hora somni (HS; at bedtime) for the induction of response to treatment (histologic...
What is the current status of trial NCT04281108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2020-01-30. Estimated completion is 2022-10-24.
What conditions does trial NCT04281108 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis.
What interventions are being tested in trial NCT04281108?
The interventions under investigation include: Esophagogastroduodenoscopy (PROCEDURE), Placebo oral tablet (DRUG), APT-1011 (DRUG).
Who is sponsoring clinical trial NCT04281108?
This trial is sponsored by Ellodi Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04281108 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04281108's enrollment target sits among peer trials
143 16th of 44 higher than 29 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis 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.
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