Efficacy and Safety APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2)

Study Purpose

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

More Inclusion & Exclusion Criteria

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-1011

Trial 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

Additional Details

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 & Interventions

Arms

Experimental: APT-1011

APT-1011 3 mg HS

Placebo Comparator: Placebo

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.

Pinnacle Research Group, LLC, Anniston, Alabama

Status

Active, not recruiting

Address

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

Site Contact

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