24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)
Public ClinicalTrials.gov record NCT05634746. 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 Disintegrating Tablet Formulation in Eosinophilic Esophagitis: A Randomized, Double-blind, Placebo-Controlled 24-Week Induction Study of APT-1011, Followed by a Single-arm 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 24-week randomized, double-blind, placebo-controlled induction study of APT-1011 in adults (≥18 years old) with eosinophilic esophagitis (EoE) followed by a single-arm, open-label extension. This study will evaluate the efficacy and safety of APT-1011 3 mg administered HS (hora somni, at bedtime) for the induction of response to treatment (symptomatic and histologic) over 24 weeks. The open-label extension will continue to evaluate long-term safety in subjects who consent to continue on open-label treatment with APT-1011.
Study identification
- NCT ID
- NCT05634746
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 218 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
- Dec 29, 2022 (Actual)
- Primary completion
- Aug 12, 2024 (Actual)
- Completion
- Aug 12, 2024 (Actual)
- Last update posted
- Aug 13, 2025
2022 – 2024
United States locations
- U.S. sites
- 59
- U.S. states
- 29
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists | Dothan | Alabama | 36301 | — |
| East View Medical Research LLC | Mobile | Alabama | 36606 | — |
| Premier Allergy Asthma and Immunology | Scottsdale | Arizona | 85255 | — |
| Del Sol Research Management, LLC. | Tucson | Arizona | 85715 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Om Research LLC | Camarillo | California | 93012 | — |
| Providence Facey Medical Foundation | Mission Hills | California | 91345 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| TriWest Research Associates, LLC | San Diego | California | 92108 | — |
| Precision Research Institute, LLC | San Diego | California | 92114 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Western States Clinical Research, Inc. | Wheat Ridge | Colorado | 80033 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| I.H.S Health, LLC | Kissimmee | Florida | 34741 | — |
| Endoscopic Research Inc | Orlando | Florida | 32803 | — |
| Revival Clinical Research | Orlando | Florida | 32807 | — |
| Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | 31201 | — |
| GI Alliance - Glenview | Glenview | Illinois | 60026 | — |
| GI Alliance - Gurnee | Gurnee | Illinois | 60031 | — |
| Deaconess Clinic Allergy | Evansville | Indiana | 47715 | — |
| Gastroenterology Health Partners, PLLC | New Albany | Indiana | 47150 | — |
| Velocity Clinical Research, Inc. | Overland Park | Kansas | 66210 | — |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland, LLC | Columbia | Maryland | 21045 | — |
| Velocity Clinical Research, Inc. | Rockville | Maryland | 20854 | — |
| Boston Specialists | Boston | Massachusetts | 02111 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Clinical Research Institute of Michigan, LLC | Troy | Michigan | 48098 | — |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | — |
| MNGI Digestive Health, P.A. | Plymouth | Minnesota | 55446 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Bozeman Health | Bozeman | Montana | 59715 | — |
| Advanced Research Institute | Reno | Nevada | 89511 | — |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | — |
| New York Gastroenterology Associates | New York | New York | 10075 | — |
| UNC Clinical and Translational Research Center (CTRC) | Chapel Hill | North Carolina | 27599-7064 | — |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28207 | — |
| Carolina Research | Greenville | North Carolina | 27834 | — |
| Bernstein Clinical Research | Cincinnati | Ohio | 45236 | — |
| Centricity Research Columbus | Columbus | Ohio | 43213 | — |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | — |
| Vital Prospects Clinical Research Institute., PC | Tulsa | Oklahoma | 74136 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Frontier Clinical Research, LLC | Uniontown | Pennsylvania | 15401 | — |
| Rapid City Medical Center, LLP | Rapid City | South Dakota | 57701 | — |
| Texas Digestive Specialists | Harlingen | Texas | 78550 | — |
| GI Alliance | Lubbock | Texas | 79410 | — |
| GI Alliance | Mansfield | Texas | 76063 | — |
| Southern Star Research Institute, LLC. | San Antonio | Texas | 78229 | — |
| GI Alliance | Webster | Texas | 77598 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Advanced Research Institute | Sandy City | Utah | 84092 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
| Washington Gastroenterology, PLLC dba GI Alliance | Bellevue | Washington | 98004 | — |
| GI Alliance | Tacoma | Washington | 98405 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05634746, 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 Aug 13, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05634746 live on ClinicalTrials.gov.