Digestive system disorder Swelling of esophagus
Conditions
Interventions
At Baseline, participants will undergo an upper EGD in combination with
treatment administration where participants will receive submucosal injections
of EP-104IAR.Administration of the IMP will be
the
EP-104IAR Powder is constituted to concentrations of 1 mg/mL, 2.5 mg/mL, 4
mg/mL, or 6 mg/mL to meet dose requirements.
The maximum dose of EP-104IAR that could be administered per injection s
Sponsors
Eupraxia Pharmaceuticals Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults 18 to 75 years of age, inclusive 2. Symptomatic EoE defined as: a. SDI >= 5 at screening and baseline b. Confirmed historical diagnosis of EoE with PEC > 15/hpf 3. For women of childbearing potential, a negative pregnancy test (at baseline) and willing to use a highly effective method of birth control between baseline and end of study 4. Willing and able to adhere to study-related procedures and visit schedule 5. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Any concomitant esophageal disease and relevant GI disease including but not limited to eosinophilic gastritis or enteritis (defined by clinicopathologic features), erosive esophagitis Los Angeles grade C or higher, Barrett*s esophagus, previous esophageal surgery, Celiac disease, inflammatory bowel disease, or any condition or history of illness or laboratory abnormality that in the investigator*s judgment might interfere with study procedures or ability to complete the study, Note: Participants with occasional gastroesophageal reflux disease (GERD) symptoms without severe (Los Angeles grade C or higher) endoscopic erosive reflux esophagitis are permitted 2. Presence of oral or esophageal mucosal infection of any type (bacterial, viral, or fungal) 3. Any oropharyngeal or dental condition that prevents normal eating 4. Known severe esophageal motility disorders other than EoE 5. Contraindication to or factors that substantially increase the risk associated with EGD or esophageal biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mm endoscope, stricture requiring dilation within the 8 weeks prior to Screening, or the need for dilation prior to EGD at baseline A history or presence of any condition for which the use of corticosteroids is contraindicated (e.g., insulin-dependent diabetes mellitus, Cushing*s syndrome, Addison*s disease, cortisol-related endocrinopathy, etc.) 6.Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]), or parasitic infections, or ocular herpes simplex. Or any infection requiring intravenous [IV] antibiotics within 4 weeks of baseline, or oral antibiotics within 2 weeks of baseline. 7. Known hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product, including carboxymethyl cellulose, hyaluronic acid, and polysorbate 80, or to the ingredients in Synacthen (used in the ACTH stimulation test) 8. Use of systemic corticosteroids within 60 days prior to baseline, or swallowed topical corticosteroids within 60 days prior to baseline, or extended use of high-potency dermal topical corticosteroids within 60 days prior to baseline 09. Use of a new inhaled or intranasal corticosteroid within 60 days prior to baseline, or a change in dose of an inhaled or intranasal corticosteroid within 60 days of baseline (a temporary dose change lasting <= 14 days is permitted) 10. Initiation of an elimination diet or elemental diet within 30 days prior to baseline (dietary therapy must remain stable throughout the study) 11. Use of biologic immunomodulators in the 90 days prior to baseline 12. Use of immunosuppressive drugs, or potent cytochrome CYP3A4 inhibitors in the 90 days prior to baseline 13. Initiated, discontinued, or changed dosage regimen of PPIs for any condition such as GERD or allergic rhinitis within 4 weeks prior to baseline. Doses must remain stable throughout the study 14. Morning serum cortisol level <= 5 µg/dL (138 nmol/L) at Screening visit 15. Use of another investigational product within the 30 days prior to baseline, or an investigational biologic within 90 days prior to baseline, or current/planned participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety • Frequency and severity of treatment-emergent adverse events (TEAEs) • Change from baseline in clinical safety laboratory measurements at Weeks 4 and 12 • Change from baseline in morning serum cortisol levels 24 hours postdose and at Weeks 2, 4, 8, 12, and 24 and Week 52 for participants who receive >40 mg total dose • Change from baseline in vital signs at 1 and 24 hours postdose and at Weeks 2, 4, 8, 12 and physical examination results at Weeks 2, 4, 8, 12 Pharmacokinetics: • Plasma concentrations of FP, measured at baseline (predose), 2 and 24 hours postdose, and at Weeks 2, 4, 8, 12, 24, and Weeks 36 and 52 for participants who receive >40 mg total dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: • Histological response mapped over the surface of the esophagus as a function of proximity to, and size of dose, measured by peak eosinophil count (PEC) at Weeks 4 and 12 and at Week 36 for participants who receive >40 mg total dose. • Change from baseline in the Straumann Dysphagia Index (SDI) patient-reported outcome (PRO) score at Weeks 2, 4, 8, 12, 24, and Weeks 36 and 52 for participants who receive >40 mg total dose. • Change from baseline in dysphagia measured on an 11 point Likert scale at Weeks 2, 4, 8, 12, 24, and Week 36 and 52 for participants who receive >40 mg total dose • Change from baseline in odynophagia measured on an 11 point Likert scale at Weeks 2, 4, 8, 12, 24, and Week 36 and 52 for participants who receive >40 mg total dose • Change from baseline in the EoE Endoscopic Reference Score (EREFS) at Weeks 4 and 12, and at Week 36 for participants who receive >40 mg total dose. • Change from baseline in EoE Histology Scoring System (EoEHSS) score at Weeks 4 and 12, and at Week 36 for participants who receive >40 mg total dose. | — |
Countries
Netherlands
Outcome results
None listed