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Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
NCT04281108 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Esophagogastroduodenoscopy
- DRUG Placebo oral tablet
- DRUG APT-1011
Study Locations (20)
California
- Camarillo Endoscopy Center — Camarillo
- Hope Clinical Research — Canoga Park
- Facey Medical Foundation — Mission Hills
- United Medical Doctors — Murrieta
- Medical Associates Research Group — San Diego
Florida
- Fleming Island Center for Clinical Research — Fleming Island
- Nature Coast Clinical Research — Inverness
- Encore Borland Groover Clinical Research — Jacksonville
- Endoscopic Research, Inc. — Orlando
Alabama
- Pinnacle Research Group, LLC — Anniston
- Gut P.C., dba; Digestive Health Specialists of the Southeast — Dothan
- East View Medical Research, LLC — Mobile
Colorado
- Asthma and Allergy Associates, PC — Colorado Springs
- Peak Gastroenterology Associates — Colorado Springs
- Western States Clinical Research Inc. — Wheat Ridge
Arkansas
- Preferred Research Partners Inc. — Little Rock
- Arkansas Gastroenterology — North Little Rock
Connecticut
- Western Connecticut Medical Group - Gastroenterology — Danbury
- Medical Research Center of Connecticut, LLC — Hamden
Arizona
- Del Sol Research Management, LLC — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2022-10-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04281108
The ClinicalTrials.gov registry entry for NCT04281108 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ellodi Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 3 interventions — of which Esophagogastroduodenoscopy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04281108 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04281108 about?
NCT04281108 is a clinical study titled "Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)". 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...
What is the current status of trial NCT04281108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2020-01-30. Estimated completion is 2022-10-24.
What conditions does trial NCT04281108 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04281108?
The interventions under investigation include: Esophagogastroduodenoscopy (PROCEDURE), Placebo oral tablet (DRUG), APT-1011 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04281108?
This trial is sponsored by Ellodi Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04281108 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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