Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
NCT ID: NCT04281108
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2020-01-30
2022-10-24
Brief Summary
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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.
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Detailed Description
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Part A will evaluate the efficacy and safety of APT-1011 3 mg administered HS for the induction of response to treatment (histologic and symptomatic) over 12 weeks.
At Week 14, subjects will move into Part B. Subjects with histological response to APT-1011, defined as ≤6 peak eos/HPF, will be re-randomized to continue APT-1011 or receive placebo (active treatment withdrawal). APT-1011 histological non-responders will continue APT-1011, and placebo histological non-responders will receive APT-1011 3 mg HS. Placebo histological responders will continue placebo. The double-blind will be sustained throughout Part B. Histological responder status will be determined at the time of esophagogastroduodenoscopy (EGD) in Part B (at or prior to Week 52, depending on unscheduled EGDs performed when the Investigator deems the subject's symptoms necessitate EGD) and is defined as ≤6 peak eos/HPF.
At Week 52, subjects may enter Part C, an open-label single-arm extension phase, and continue study drug uninterrupted. Part C will terminate upon regulatory approval of APT-1011 or Sponsor termination of the study.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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APT-1011
APT-1011 3 mg HS
APT-1011
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Esophagogastroduodenoscopy
Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus.
Placebo
HS
Placebo oral tablet
Placebo orally disintegrating tablet.
Esophagogastroduodenoscopy
Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus.
Interventions
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APT-1011
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Placebo oral tablet
Placebo orally disintegrating tablet.
Esophagogastroduodenoscopy
Esophagogastroduodenoscopy (EGD) is a test that involves an endoscope, a lighted camera on the end of a tube, that is passed down a subject's throat to visualize their esophagus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Each subject must read, understand, and provide consent on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures, and visit schedule
3. Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates ≥15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 6 biopsies should be taken including both proximal and distal specimens (at least 3 each). Mid-esophageal biopsies are not required (optional). HPF will be defined as a standard area of 235 square microns in a microscope with 40x lens (0.3 mm\^2) and 22 mm ocular.
1. Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
2. Biopsies will be read by a central pathologist
3. Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
4. Optional biopsies may be taken and processed locally for local use, if specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
4. Have a subject-reported history of ≥6 episodes of dysphagia in the 14 days prior to baseline
5. Completion of the daily diary on at least 11 out of the 14 days during the 2-week Baseline Symptom Assessment
Exclusion Criteria
2. Have a contraindication to, or factors that substantially increase the risk of, EGD procedure or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope
3. Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
4. Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study or increase the safety risk to the subject such as uncontrolled diabetes or hypertension
5. History or presence of oral or esophageal mucosal infection whilst using inhaled or nasal corticosteroids
6. Have any mouth or dental condition that prevents normal eating (excluding braces)
7. Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE, including erosive esophagitis (grade B or higher as per the Los Angeles Classification of Gastroesophageal Reflux Disease; hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia)
8. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening
9. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
10. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
11. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening
12. Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
13. Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level ≤5 μg/dL (138 nmol/L) that is not responsive to adrenocorticotropic hormone (ACTH) stimulation: defined as a serum cortisol level \<16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin (i.e., an abnormal result on the ACTH stimulation test)
14. Use of biologic immunomodulators in the 24 weeks before Screening (allergy desensitization injection or oral therapy is allowed as long as the course of therapy is not altered during the study period)
15. Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines for any condition such as gastro-esophageal reflux disease within 4 weeks before qualifying endoscopy during Screening. If already receiving these drugs, the dosage must remain constant throughout the study
16. Subjects who have changed dosage regimen of PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage must remain constant throughout the study
17. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus
18. Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
19. Have chronic infection such as prior or active tuberculosis, active chicken pox or measles or absence of prior measles, mumps and rubella vaccine. Subjects with tuberculosis exposure or who live in, or travel to, high endemic areas should be assessed locally for tuberculosis before consideration for the study
20. Immunosuppression or immunodeficiency disorder
21. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis
22. Have current drug abuse in the opinion of the Investigator.
23. Have current alcohol abuse in the opinion of the Investigator.
24. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
25. Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit
26. Have received an investigational product, as part of a clinical trial within 30 days (or 5 half-lives, whichever is longest) of Screening. Subjects who are currently participating in observational studies or enrolled in patient registries are allowed in this study
27. Have participated in a prior study with investigational product APT-1011
18 Years
ALL
No
Sponsors
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Ellodi Pharmaceuticals, LP
INDUSTRY
Responsible Party
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Principal Investigators
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Evan Dellon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UNC Center for Eosphageal Diseases and Swallowing
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Gut P.C., dba; Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
East View Medical Research, LLC
Mobile, Alabama, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Preferred Research Partners Inc.
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Camarillo Endoscopy Center
Camarillo, California, United States
Hope Clinical Research
Canoga Park, California, United States
Facey Medical Foundation
Mission Hills, California, United States
United Medical Doctors
Murrieta, California, United States
Medical Associates Research Group
San Diego, California, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Western States Clinical Research Inc.
Wheat Ridge, Colorado, United States
Western Connecticut Medical Group - Gastroenterology
Danbury, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Encore Borland Groover Clinical Research
Jacksonville, Florida, United States
Endoscopic Research, Inc.
Orlando, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
Summit Clinical Research
Athens, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Bozeman Health GI Clinic
Bozeman, Montana, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
University of North Carolina Health Systems (UNC Hospital)
Chapel Hill, North Carolina, United States
Carolina Research
Greenville, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Digestive Disease Associates LTD
Wyomissing, Pennsylvania, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, United States
DHAT Research Institute
Garland, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Verity Research, Inc.
Fairfax, Virginia, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Swallow Clinic, St George Hospital
Kogarah, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Hosital General de Tomelloso
Tomelloso, Ciudad Real, Spain
Hospital Universitario Ramón y Cajal (Madrid)
Madrid, , Spain
Countries
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Other Identifiers
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SP-1011-003
Identifier Type: -
Identifier Source: org_study_id
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