Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
Public ClinicalTrials.gov record NCT04281108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 With an Open-label Extension, in Adult Subjects With Eosinophilic Esophagitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04281108
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 143 participants
Conditions and interventions
Conditions
Interventions
- APT-1011 Drug
- Placebo oral tablet Drug
- Esophagogastroduodenoscopy Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2020 (Actual)
- Primary completion
- May 5, 2022 (Actual)
- Completion
- Oct 24, 2022 (Actual)
- Last update posted
- Jun 12, 2023
2020 – 2022
United States locations
- U.S. sites
- 48
- U.S. states
- 23
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| Gut P.C., dba; Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| East View Medical Research, LLC | Mobile | Alabama | 36606 | — |
| Del Sol Research Management, LLC | Tucson | Arizona | 85712 | — |
| Preferred Research Partners Inc. | Little Rock | Arkansas | 72211 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Camarillo Endoscopy Center | Camarillo | California | 93012 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | 80907 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Western States Clinical Research Inc. | Wheat Ridge | Colorado | 80033 | — |
| Western Connecticut Medical Group - Gastroenterology | Danbury | Connecticut | 06810 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| Encore Borland Groover Clinical Research | Jacksonville | Florida | 32256 | — |
| Endoscopic Research, Inc. | Orlando | Florida | 32803 | — |
| DBC Research USA | Pembroke Pines | Florida | 33029 | — |
| Summit Clinical Research | Athens | Georgia | 30607 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | — |
| Michigan Medicine, University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan LLC | Chesterfield | Michigan | 48047 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | — |
| Minnesota Gastroenterology, P.A. | Plymouth | Minnesota | 55446 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Bozeman Health GI Clinic | Bozeman | Montana | 59715 | — |
| Long Island Gastrointestinal Research Group LLP | Great Neck | New York | 11023 | — |
| University of North Carolina Health Systems (UNC Hospital) | Chapel Hill | North Carolina | 27599 | — |
| Carolina Research | Greenville | North Carolina | 27834 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45231 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | — |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Digestive Disease Associates LTD | Wyomissing | Pennsylvania | 19610 | — |
| Rapid City Medical Center LLP | Rapid City | South Dakota | 57701 | — |
| DHAT Research Institute | Garland | Texas | 75044 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| Verity Research, Inc. | Fairfax | Virginia | 22031 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04281108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2023 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04281108 live on ClinicalTrials.gov.