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Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial

NCT05083312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-09-21

No results posted yet for this 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.

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

Sponsors & Collaborators

  • Ellodi Pharmaceuticals, LP

    lead INDUSTRY

Principal Investigators

  • Mirna Chehade, MD, MPH · Mount Sinai Center for Eosinophilic Disorders

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-09-05
Completion
2022-09-05
FDA Drug
Yes

Countries

  • United States
  • Australia

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 NCT05083312 on ClinicalTrials.gov