Condition: Eosinophilic Esophagitis · Sponsor: Eupraxia Pharmaceuticals Inc.
A Phase 1b/2 study to explore the safety, efficacy and pharmacokinetics of EP-104GI in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. 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). In the Phase 2 randomized dose optimization portion of the study, approximately 120 subjects will be randomized to Dose A (120 mg total dose), Dose B (160 mg total dose), or matching vehicle control, with an overall assignment ratio of 1:1:1. The total number of participants in both portions of the study will be approximately 160. The study involves 8-10 site visits spread over approximately 52 weeks. Participants in an extended PK sub study will have up to 4 additional visits, to a maximum of 108 weeks post-dose. The participants will either receive the active study drug (EP-104GI) or matching vehicle control. Matching vehicle control will be used only in randomized dose optimization portion of the study. Participants randomized …
This description comes directly from the study's public registry record.
Pranali Ravikumar, MS · 647-895-3016 · pravikumar@eupraxiapharma.com
Always discuss trial participation with your own doctor first.
| Campbelltown Private Hospital | Sydney, New South Wales, Australia | Recruiting |
| Mater Hospital Brisbane | Brisbane, Queensland, Australia | Recruiting |
| Princess Alexandra Hospital | Brisbane, Queensland, Australia | Recruiting |
| Coastal Digestive Health | Maroochydore, Queensland, Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| Eastern Health Box Hill | Box Hill, Victoria, Australia | Recruiting |
| Northern Hospital Epping | Epping, Victoria, Australia | Recruiting |
| The Alfred Hospital | Melbourne, Victoria, Australia | Recruiting |
| Royal Melbourne Hospital | Parkville, Victoria, Australia | Recruiting |
| University of Calgary | Calgary, Alberta, Canada | Recruiting |
| UoA - South Edmonton Gastroenterology Research Clinic | Edmonton, Alberta, Canada | Recruiting |
| G.I. Research Institute | Vancouver, British Columbia, Canada | Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05608681