24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3)
Eosinophilic Esophagitis
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Digestive System Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders, Hematologic Diseases, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Fluticasone, Anti-Inflammatory Agents, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Anti-Asthmatic Agents, Respiratory System Agents, Anti-Allergic Agents, FLUTE 3, FLUTE III, Flute
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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 Have participated in a prior study with investigational product APT-1011
Sites / Locations
- Digestive Health SpecialistsRecruiting
- East View Medical Research LLCRecruiting
- Premier Allergy Asthma and ImmunologyRecruiting
- Del Sol Research Management, LLC.Recruiting
- Preferred Research Partners, Inc.Recruiting
- Arkansas GastroenterologyRecruiting
- Om Research LLCRecruiting
- Providence Facey Medical FoundationRecruiting
- United Medical DoctorsRecruiting
- TriWest Research Associates, LLCRecruiting
- Peak Gastroenterology AssociatesRecruiting
- Western States Clinical Research, Inc.Recruiting
- Medical Research Center of Connecticut, LLCRecruiting
- Endoscopic Research IncRecruiting
- Revival Clinical ResearchRecruiting
- Summit Clinical Research, LLCRecruiting
- GI Alliance - GlenviewRecruiting
- GI Alliance - GurneeRecruiting
- Gastroenterology Health Partners, PLLCRecruiting
- University of Iowa Hospitals & ClinicsRecruiting
- MGG Group Co., Inc., Chevy Chase Clinical ResearchRecruiting
- Gastro Center of Maryland, LLCRecruiting
- Velocity Clinical Research, Inc.Recruiting
- Boston SpecialistsRecruiting
- Clinical Research Institute of Michigan, LLCRecruiting
- Clinical Research Institute of Michigan, LLCRecruiting
- Gastroenterology Associates of Western MichiganRecruiting
- MNGI Digestive Health, P.A.Recruiting
- Clinical Research ProfessionalsRecruiting
- Bozeman HealthRecruiting
- Advanced Research InstituteRecruiting
- New Mexico Clinical Research & Osteoporosis Center, Inc.Recruiting
- Long Island Gastrointestinal Research Group LLPRecruiting
- UNC Clinical and Translational Research Center (CTRC)Recruiting
- Charlotte Gastroenterology & Hepatology, PLLCRecruiting
- Carolina ResearchRecruiting
- Bernstein Clinical ResearchRecruiting
- Centricity Research ColumbusRecruiting
- Northshore Gastroenterology Research, LLCRecruiting
- Vital Prospects Clinical Research Institute., PCRecruiting
- Perelman Center for Advanced MedicineRecruiting
- Frontier Clinical Research, LLCRecruiting
- Rapid City Medical Center, LLPRecruiting
- Texas Digestive SpecialistsRecruiting
- GI AllianceRecruiting
- GI AllianceRecruiting
- Southern Star Research Institute, LLC.Recruiting
- GI AllianceRecruiting
- Tranquil Clinical ResearchRecruiting
- Advanced Research InstituteRecruiting
- University of Utah HospitalRecruiting
- Advanced Research InstituteRecruiting
- Blue Ridge Medical ResearchRecruiting
- Washington Gastroenterology, PLLC dba GI AllianceRecruiting
- GI AllianceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
APT-1011
Placebo
APT-1011 3 mg HS
Placebo HS