a trial to evaluate ep-104iar in adults with eosinophilic esophagitis (eoe).

Conditions: Eosinophilic Esophagitis

Summary: an open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of ep-104iar in adults with eosinophilic esophagitis (eoe). endoscopic and histologic assessments will also be evaluated to understand the local effects of ep-104iar on eosinophilic eoe disease activity. approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort in approximately 9 cohorts. the number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded. an additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (rp2d). the study involves 8-10 site visits spread over approximately 24-52 weeks. all participants will receive active study drug (ep-104iar), the study drug will be administered by qualified personnel during an esophagogastroduodenoscopy (egd) procedure at the baseline/dosing visit. safety will be assessed throughout the study. blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of ep-104iar. participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-4 egds with esophageal biopsies at the baseline/dosing visit, at 4, 12 and 36 weeks post dose.


Eligibility criteria:
inclusion criteria: * symptomatic eoe; * for women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study; * willing and able to adhere to study-related procedures and visit schedule; * willing and able to provide informed consent. exclusion criteria: * concomitant esophageal disease, relevant gi disease, or any condition, history, or laboratory abnormality that might interfere with the study; * oral or esophageal mucosal infection of any type (bacterial, viral, or fungal); * oropharyngeal or dental conditions that prevents normal eating; * severe esophageal motility disorders other than eoe; * contraindication to or factors that substantially increase risks associated with egd or biopsy, or narrowing of the esophagus that precludes egd with a standard 9-10 mm endoscope, stricture requiring dilation within 8 weeks prior to screening, or the need for dilation prior to egd at baseline; * any condition for which the use of corticosteroids is contraindicated (participants with well controlled non-insulin dependent diabetes are permitted); * active or quiescent systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. or recent use of iv or oral antibiotics; * hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product; * recent use of disallowed medications, or unwillingness to not use disallowed medications during the study; * recent initiation of a elimination or elemental diet (dietary therapy must remain stable throughout the study); * morning serum cortisol level ≤ 5 μg/dl (138 nmol/l); * clinically significant abnormal laboratory values; * recent or currently planned participation in another interventional trial ; * previous participation in this study and had received study treatment; * females who are pregnant, breastfeeding, or planning to become pregnant during the study; * malignancies or history of malignancy within prior 5 years, except for treated or excised non-metastatic bcc, scc of the skin, or cervical carcinoma in situ; * history of alcohol or drug abuse; * any other reason, that, in the investigator's opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements.