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A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
Sponsor: Eupraxia Pharmaceuticals Inc.
Summary
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 to receive vehicle control may receive EP-104GI (Dose A or Dose B) following the completion of Week 24 providing they meet eligibility criteria for crossover to EP-104GI. Participants randomized to receive EP-104GI on Day 0 will not receive EP-104GI or vehicle control at Week 24. The study drug or matching vehicle control 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-104GI. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-5 EGDs with esophageal biopsies at the Baseline, Week 4 (dose escalation phase only), Week 12, Week 24 (randomized dose optimization phase only), Week 26, and Week 52 (randomized dose optimization phase only).
Official title: A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2023-03-31
Completion Date
2026-12
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Locations (23)
Campbelltown Private Hospital
Sydney, New South Wales, Australia
Mater Hospital Brisbane
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Coastal Digestive Health
Maroochydore, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Eastern Health Box Hill
Box Hill, Victoria, Australia
Northern Hospital Epping
Epping, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
G.I. Research Institute
Vancouver, British Columbia, Canada
McGill University Health Center
Montreal, Quebec, Canada
Amsterdam UMC
Amsterdam, Netherlands
Erasmus University Medical Center
Holland, Netherlands
Aotearoa Clinical Trials
Papatoetoe, Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Capital Coast and Hutt
Lower Hutt, New Zealand
Universitätsspital Zürich
Zurich, Switzerland
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Cardiff and Vale University Health Board-Wales
Cardiff, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
St George's University of London
London, United Kingdom