A Trial Evaluating EP-104IAR in Adults With Eosinophilic Esophagitis

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

The study will evaluate up to 8 doses of EP-104IAR (4 mg to 40 mg) in cohorts of 3 to 6 participants per cohort. If all planned cohorts are evaluated, or cohorts need to be repeated, up to 24 participants could be enrolled.

The study involves 7 site visits spread over approximately 18 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 EGDs with esophageal biopsies at the Baseline/Dosing Visit, and at 4 and 12 weeks post dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eupraxia Pharmaceuticals Inc.

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.