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Monoclonal Antibodies

APT-1011 for Eosinophilic Esophagitis (FLUTE-2 Trial)

Phase 3
Waitlist Available
Led By Evan Dellon, 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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 52
Awards & highlights

FLUTE-2 Trial Summary

This trial will study the effects of APT-1011 on adults with EoE. The study will last for 52 weeks and will look at the efficacy and safety of APT-1011.

Eligible Conditions
  • Eosinophilic Esophagitis

FLUTE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histologic responder rates at the end of the Randomized Withdrawal Phase (RWS)
Mean change in number of dysphagia episodes
Percentage subjects with complete symptomatic response at the end of the RWS
+1 more
Secondary outcome measures
Change in EREFs from Week 0 to Week 12
Mean Change in Dysphagia Episodes
Mean Change in Dysphagia-Free Days
+10 more

FLUTE-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: APT-1011Experimental Treatment2 Interventions
APT-1011 3 mg HS
Group II: PlaceboPlacebo Group2 Interventions
HS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APT-1011
2020
Completed Phase 3
~260
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980

Find a Location

Who is running the clinical trial?

Ellodi Pharmaceuticals, LPLead Sponsor
3 Previous Clinical Trials
206 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
206 Patients Enrolled for Eosinophilic Esophagitis
Evan Dellon, MD, MPHPrincipal InvestigatorUNC Center for Eosphageal Diseases and Swallowing
2 Previous Clinical Trials
286 Total Patients Enrolled
2 Trials studying Eosinophilic Esophagitis
286 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.

Who else is applying?

What state do they live in?
Virginia
Indiana
How old are they?
65+
18 - 65
What site did they apply to?
IU School of Medicine Department of Pediatrics
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
2020. "Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04281108.
~28 spots leftby Apr 2025
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