Efficacy and Safety APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)
Study Purpose
This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥12 years) with EoE. 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. Part B will evaluate histological relapse-free status in patients re-randomized to continue APT-1011 or placebo (active treatment withdrawal) until Week 52.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Inclusion Criteria:
1. Male or female ≥12 years of age at the time of informed consent or assent. 2. Each subject and/or their parents or legal guardian (for adolescents), must read, understand and provide consent or assent together with their parent(s) or guardian signature (for adolescents) 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 5-6 biopsies should be taken including both proximal and distal specimens (~3 each). Mid-esophageal biopsies are optional. 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:
1. Have known contraindication, hypersensitivity, or intolerance to corticosteroids. 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. Bone age more than 12 months behind chronological age for adolescent subjects. 5. 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 or may increase risk of corticosteroid toxicity (e.g. abnormal bone mineral density) 6. History or presence of oral or esophageal mucosal infection whilst using inhaled or nasal corticosteroids. 7. Have any mouth or dental condition that prevents normal eating (excluding braces) 8. 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;19, hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia) 9. Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening. 10. Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening. 11. Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening. 12. Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening. 13. Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF) 14. 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 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 (ie, an abnormal result on the ACTH stimulation test) 15. 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) 16. 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. 17. 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. 18. Infection with hepatitis B, hepatitis C, or human immunodeficiency virus. 19. Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period. 20. 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. 21. Have immunosuppression, immunodeficiency, malignancy (except treated non-melanoma skin cancer), or known severe bleeding disorder. 22. Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including eosinophilic gastroenteritis. 23. Have current drug abuse in the opinion of the Investigator. 24. Have current alcohol abuse in the opinion of the Investigator. 25. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study. 26. Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit. 27. 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. 28. Have participated in a prior study with investigational product APT-1011Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04281108 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Ellodi Pharmaceuticals, LP |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Evan Dellon, MD, MPH |
Principal Investigator Affiliation | UNC Center for Eosphageal Diseases and Swallowing |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Germany, Spain, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Eosinophilic Esophagitis |
This is a 2-part randomized, double-blind, placebo-controlled study of APT-1011 in adults and adolescents (≥12 years) with EoE. 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, placebo histological non-responders will receive APT-1011 3mg HS. Placebo histological responders will continue placebo. Histological responder status will be determined at the time of EGD in Part B (at or prior to Week 52, depending on unscheduled EGDs) and is defined as ≤6 peak eos/HPF.
Arms
Experimental: APT-1011
APT-1011 3 mg HS
Placebo Comparator: Placebo
HS
Interventions
Drug: - APT-1011
APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.
Drug: - Placebo oral tablet
Placebo orally disintegrating tablet.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Status
Withdrawn
Address
Gut P.C., dba; Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
Status
Active, not recruiting
Address
East View Medical Research, LLC
Mobile, Alabama, 36606
Status
Active, not recruiting
Address
Del Sol Research Management, LLC
Tucson, Arizona, 85712
Status
Active, not recruiting
Address
Preferred Research Partners Inc.
Little Rock, Arkansas, 72211
Status
Active, not recruiting
Address
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Status
Active, not recruiting
Address
Camarillo Endoscopy Center
Camarillo, California, 93012
Status
Active, not recruiting
Address
Hope Clinical Research
Canoga Park, California, 91303
Status
Withdrawn
Address
TriWest Research Associates, LLC
El Cajon, California, 92020
Status
Withdrawn
Address
Om Research LLC
Lancaster, California, 93534
Status
Active, not recruiting
Address
Facey Medical Foundation
Mission Hills, California, 91345
Status
Active, not recruiting
Address
United Medical Doctors
Murrieta, California, 92563
Status
Active, not recruiting
Address
Children's Hospital of Orange County
Orange, California, 92868
Status
Withdrawn
Address
Stanford University Medical Center, Division of Gastroenterology and Hepatology
Redwood City, California, 94063
Status
Withdrawn
Address
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
Status
Active, not recruiting
Address
Medical Associates Research Group
San Diego, California, 92123
Status
Withdrawn
Address
Great Lakes Medical Research LLC
San Diego, California, 92130
Status
Active, not recruiting
Address
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Status
Active, not recruiting
Address
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Status
Not yet recruiting
Address
Rocky Mountain Pediatric Gastroenterology
Denver, Colorado, 80214
Status
Active, not recruiting
Address
Western States Clinical Research Inc.
Wheat Ridge, Colorado, 80033
Status
Active, not recruiting
Address
Western Connecticut Medical Group - Gastroenterology
Danbury, Connecticut, 06810
Status
Active, not recruiting
Address
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Status
Active, not recruiting
Address
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Status
Withdrawn
Address
Universal Axon - Homestead, LLC
Homestead, Florida, 33030
Status
Active, not recruiting
Address
Nature Coast Clinical Research
Inverness, Florida, 34452
Status
Active, not recruiting
Address
Encore Borland Groover Clinical Research
Jacksonville, Florida, 32256
Status
Active, not recruiting
Address
Endoscopic Research, Inc.
Orlando, Florida, 32803
Status
Active, not recruiting
Address
DBC Research USA
Pembroke Pines, Florida, 33029
Status
Active, not recruiting
Address
Summit Clinical Research
Athens, Georgia, 30607
Status
Withdrawn
Address
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Status
Not yet recruiting
Address
IU School of Medicine Department of Pediatrics
Indianapolis, Indiana, 46202
Status
Active, not recruiting
Address
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Status
Withdrawn
Address
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Status
Active, not recruiting
Address
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Status
Active, not recruiting
Address
Gastro Center of Maryland
Columbia, Maryland, 21045
Status
Recruiting
Address
Tufts Medical Centre
Boston, Massachusetts, 02111
Status
Active, not recruiting
Address
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, 48109
Status
Active, not recruiting
Address
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047
Status
Active, not recruiting
Address
Henry Ford Health System
Novi, Michigan, 48377
Status
Active, not recruiting
Address
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
Status
Active, not recruiting
Address
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446
Status
Active, not recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Active, not recruiting
Address
Clinical Research Professionals
Chesterfield, Missouri, 63005
Status
Active, not recruiting
Address
Bozeman Health GI Clinic
Bozeman, Montana, 59715
Status
Withdrawn
Address
Allergy, Asthma & Immunology Associates, PC
Lincoln, Nebraska, 68505
Status
Active, not recruiting
Address
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023
Status
Withdrawn
Address
Weill Cornell Medical College
New York, New York, 10021
Status
Not yet recruiting
Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Status
Active, not recruiting
Address
University of North Carolina Health Systems (UNC Hospital)
Chapel Hill, North Carolina, 27599
Status
Withdrawn
Address
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207
Status
Withdrawn
Address
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Status
Active, not recruiting
Address
Carolina Research
Greenville, North Carolina, 27834
Status
Withdrawn
Address
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Status
Active, not recruiting
Address
Gastroenterology Associates of Cleveland, Inc.
Beachwood, Ohio, 44122
Status
Active, not recruiting
Address
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Status
Active, not recruiting
Address
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Status
Active, not recruiting
Address
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Status
Active, not recruiting
Address
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145
Status
Active, not recruiting
Address
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Status
Withdrawn
Address
Crisor LLC, c/o Clinical Research Institute of Southern Oregon PC
Medford, Oregon, 97504
Status
Active, not recruiting
Address
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Status
Active, not recruiting
Address
Digestive Disease Associates LTD
Wyomissing, Pennsylvania, 19610
Status
Active, not recruiting
Address
Rapid City Medical Center LLP
Rapid City, South Dakota, 57701
Status
Withdrawn
Address
Galen Medical Group
Chattanooga, Tennessee, 37404
Status
Withdrawn
Address
Lonestar Gastroenterology
Austin, Texas, 78745
Status
Active, not recruiting
Address
DHAT Research Institute
Garland, Texas, 75044
Status
Withdrawn
Address
Invesclinic US LLC
McAllen, Texas, 78503
Status
Active, not recruiting
Address
Advanced Research Institute
Ogden, Utah, 84405
Status
Withdrawn
Address
University of Utah Hospital
Salt Lake City, Utah, 84132
Status
Active, not recruiting
Address
Verity Research, Inc.
Fairfax, Virginia, 22031
Status
Active, not recruiting
Address
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Status
Withdrawn
Address
Washington Gastroenterology
Bellevue, Washington, 98004
International Sites
Status
Active, not recruiting
Address
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Status
Active, not recruiting
Address
Swallow Clinic, St George Hospital
Kogarah, New South Wales, 2217
Status
Active, not recruiting
Address
John Hunter Hospital
New Lambton, New South Wales, 2305
Status
Not yet recruiting
Address
Westmead Children's Hospital
Westmead, New South Wales, 02145
Status
Active, not recruiting
Address
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Status
Active, not recruiting
Address
Box Hill Hospital
Box Hill, Victoria, 3128
Status
Withdrawn
Address
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Status
Active, not recruiting
Address
Alfred Hospital
Melbourne, Victoria, 3004
Status
Recruiting
Address
Royal Children's Hospital
Melbourne, Victoria, 3052
Status
Withdrawn
Address
Klinikum rechts der Isar der TU Munchen
Munich, Bavaria, 81675
Status
Withdrawn
Address
Gastro Campus Research GbR
Münster, NRW, 48159
Status
Active, not recruiting
Address
Hosital General de Tomelloso
Tomelloso, Ciudad Real, 13700
Status
Withdrawn
Address
Hospital Universitari Vall de Hebron-VHIR
Barcelona, , 8035
Status
Withdrawn
Address
Hospital Universitario de la Princesa
Madrid, , 28006
Status
Active, not recruiting
Address
Hospital Universitario Ramón y Cajal (Madrid)
Madrid, , 28034
Status
Withdrawn
Address
Hospital Universitario Virgen Macarena
Sevilla, , 41009
Status
Withdrawn
Address
Hospital Clinico Universitario de Valencia
Valencia, , 46010
Status
Withdrawn
Address
Hospital Universitario Miguel Servet
Zaragoza, , 50009