← Back to Search

Other

APT-1011 for Eosinophilic Esophagitis (FLUTEEN Trial)

Phase 3
Waitlist Available
Led By Mirna Chehade, MD, MPH
Research Sponsored by Ellodi Pharmaceuticals, LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

FLUTEEN Trial Summary

This study is evaluating whether a drug called APT-1011 might help people with eosinophilic esophagitis.

Eligible Conditions
  • Eosinophilic Esophagitis

FLUTEEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in number of dysphagia episodes
Week 12 histologic responder rates
Secondary outcome measures
Histologic Change from Baseline to Week 12
Mean change in EREFs from Week 0 to Week 12
Mean change in PROSE Symptom Burden Score
+4 more

Side effects data

From 2019 Phase 2 trial • 106 Patients • NCT03191864
14%
Nasopharyngitis
10%
Nasal congestion
10%
Back pain
10%
Oropharyngeal pain
5%
Gilbert's syndrome
5%
Pyrexia
5%
Chills
5%
Headache
5%
Libido decreased
5%
Myalgia
5%
Gastroenteritis viral
5%
Face oedema
5%
Faeces pale
5%
Aspartate aminotransferase increased
5%
Alanine aminotransferase increased
5%
Blood bilirubin increased
5%
Bundle branch block right
5%
Viral upper respiratory tract infection
5%
Sinusitis
5%
Dyspepsia
5%
Erosive oesophagitis
5%
Oral pain
5%
Syncope
5%
Pulmonary congestion
5%
Arthropod bite
5%
Type 2 diabetes mellitus
5%
Oedema peripheral
5%
Flatulence
5%
Abdominal distension
5%
Hepatic steatosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
APT-1011 1.5 mg HS Part 1
APT-1011 1.5 mg BID Part 1
APT-1011 3 mg HS Part 1
APT-1011 3 mg BID Part 1
Placebo BID Part 1
Double-blind APT-1011 1.5 mg HS Part 2
Double-blind APT-1011 1.5 mg BID Part 2
Double-blind APT-1011 3 mg HS Part 2
Double-blind APT-1011 3 mg BID Part 2
Single-blind APT-1011 3mg BID Part 2
Total APT-1011 3 mg BID Part 2

FLUTEEN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: APT-1011Experimental Treatment1 Intervention
APT-1011 3 mg HS
Group II: PlaceboPlacebo Group1 Intervention
HS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APT-1011
2020
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Ellodi Pharmaceuticals, LPLead Sponsor
3 Previous Clinical Trials
343 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
343 Patients Enrolled for Eosinophilic Esophagitis
Mirna Chehade, MD, MPHPrincipal InvestigatorMount Sinai Center for Eosinophilic Disorders
1 Previous Clinical Trials
709 Total Patients Enrolled
1 Trials studying Eosinophilic Esophagitis
709 Patients Enrolled for Eosinophilic Esophagitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial
2021. "Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05083312.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top