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Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)

NCT04281108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-06-12

No results posted yet for this 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

  • Eosinophilic Esophagitis

Interventions

DRUG

APT-1011

APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.

DRUG

Placebo oral tablet

Placebo orally disintegrating tablet.

PROCEDURE

Esophagogastroduodenoscopy

Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus.

Sponsors & Collaborators

  • Ellodi Pharmaceuticals, LP

    lead INDUSTRY

Principal Investigators

  • Evan Dellon, MD, MPH · UNC Center for Eosphageal Diseases and Swallowing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2022-05-05
Completion
2022-10-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281108 on ClinicalTrials.gov