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Study identifier: NCT04281108 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Completed

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

Condition: Eosinophilic Esophagitis  ·  Sponsor: Ellodi Pharmaceuticals, LP

PhasePhase 3
Planned participants143
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (56)

Pinnacle Research Group, LLCAnniston, Alabama, United States
Gut P.C., dba; Digestive Health Specialists of the SoutheastDothan, Alabama, United States
East View Medical Research, LLCMobile, Alabama, United States
Del Sol Research Management, LLCTucson, Arizona, United States
Preferred Research Partners Inc.Little Rock, Arkansas, United States
Arkansas GastroenterologyNorth Little Rock, Arkansas, United States
Camarillo Endoscopy CenterCamarillo, California, United States
Hope Clinical ResearchCanoga Park, California, United States
Facey Medical FoundationMission Hills, California, United States
United Medical DoctorsMurrieta, California, United States
Medical Associates Research GroupSan Diego, California, United States
Asthma and Allergy Associates, PCColorado Springs, Colorado, United States

+ 44 more locations — full list on the registry record.

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