MedTrace Logo

Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)

NCT03191864 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-04-26

Study results available
· View outcomes & findings →

Summary

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE.

APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

APT-1011

APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate

DRUG

Placebo

Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.

Sponsors & Collaborators

  • Adare Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter C Richardson · Adare Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-01-03
Completion
2019-10-23
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT03191864 on ClinicalTrials.gov