24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)

Completed · Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

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.

Key facts

Study ID

NCT05634746

Run by

Ellodi Pharmaceuticals, LP

People needed

218

Starts

2022-12-29

Expected to finish

2024-08-12

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female ≥18 years of age at the time of informed consent
• 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
• 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 in total from both proximal and distal esophageal mucosal areas (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.
• Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period
• Biopsies will be read by a central pathologist
• Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria
• Optional biopsies may be taken and processed locally for local use, only where specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
• Have a subject-reported history of ≥6 episodes to a maximum of 30 episodes of dysphagia in a 14-consecutive-day period within 18 days prior to baseline
• Completion of the evening eDiary on at least 11 out of the 14-consecutive-day observation period during the 4-week run-in period (Baseline Symptom Assessment).The minimum requirement of 11 days need not be consecutive.

You may not qualify if…

• Have known contraindication, hypersensitivity, or intolerance to corticosteroids
• 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 (8-10 mm) endoscope
• Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
• 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
• History of recurrent or current oral or esophageal mucosal infection due to inhaled or nasal corticosteroids
• Have any mouth or dental condition that prevents normal eating (excluding braces)
• 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)
• Use of systemic (oral or parenteral) corticosteroids within 30 days before Screening, use of swallowed corticosteroids within 30 days before Screening
• Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
• Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
• Use of potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ritonavir and ketoconazole) in the 4 weeks before Screening
• Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
• Abnormal 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
• Use of biologic immunomodulators, including dupilumab for EoE, with dose last administered within 6 months before Screening (allergy desensitization injection or oral therapies allowed as long as the course of therapy is not altered during the study period)
• Subjects who have initiated, discontinued, or changed dosage regimen of histamine H2 receptor antagonists, antacids or antihistamines, leukotriene inhibitors, or sodium cromolyn within 4 weeks before qualifying endoscopy during Screening. If already receiving these drugs, the dosage must remain constant throughout the study
• Subjects who have initiated PPIs within 8 weeks before qualifying endoscopy. If already receiving PPIs, the dosage regimen must remain constant throughout the study
• Have gastrointestinal bleeding or documented active peptic ulcer within 4 weeks prior to Screening or entering a new study period
• 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
• Immunosuppression or immunodeficiency disorder
• Current malignancy or malignancy within 3 years of Screening, with the exception of skin cancers other than melanoma. Subjects in remission for at least 3 years post-treatment may be enrolled.
• Have a history or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract, including non-EoE eosinophilic gastrointestinal disorders (EGIDs)
• Have current drug abuse in the opinion of the Investigator
• Have current alcohol abuse in the opinion of the Investigator
• Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
• Sexually active females of childbearing potential who do not agree to follow highly effective contraceptive methods through the End of Study visit

Where it is running

• Digestive Health Specialists — 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
• Om Research LLC — Camarillo, California, United States
• Providence Facey Medical Foundation — Mission Hills, California, United States
• United Medical Doctors — Murrieta, California, United States
• TriWest Research Associates, LLC — San Diego, California, United States
• Precision Research Institute, LLC — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Western States Clinical Research, Inc. — Wheat Ridge, Colorado, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• I.H.S Health, LLC — Kissimmee, Florida, United States
• Endoscopic Research Inc — Orlando, Florida, United States
• Revival Clinical Research — Orlando, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC — Macon, Georgia, United States
• GI Alliance - Glenview — Glenview, Illinois, United States
• GI Alliance - Gurnee — Gurnee, Illinois, United States
• Deaconess Clinic Allergy — Evansville, Indiana, United States
• Gastroenterology Health Partners, PLLC — New Albany, Indiana, United States
• Velocity Clinical Research, Inc. — Overland Park, Kansas, United States
• MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Premier Allergy Asthma and Immunology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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