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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 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.

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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.

Conditions Studied

Eosinophilic Esophagitis

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

FieldValue
Enrollment Target 143 participants
Start Date 2020-01-30
Est. Completion 2022-10-24
Phase Phase 3

Sponsor

Ellodi Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04281108

The ClinicalTrials.gov registry entry for NCT04281108 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 861-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (83% lower). The listed sponsor is Ellodi Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.