A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (NCT05608681)
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Campbelltown Private Hospital — Sydney, New South Wales
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Campbelltown Private Hospital — Sydney, New South Wales
- Mater Hospital Brisbane — Brisbane, Queensland
- Princess Alexandra Hospital — Brisbane, Queensland
- Coastal Digestive Health — Maroochydore, Queensland
- Royal Adelaide Hospital — Adelaide, South Australia
- Eastern Health Box Hill — Box Hill, Victoria
- Northern Hospital Epping — Epping, Victoria
- The Alfred Hospital — Melbourne, Victoria
- Royal Melbourne Hospital — Parkville, Victoria
- University of Calgary — Calgary, Alberta
- UoA - South Edmonton Gastroenterology Research Clinic — Edmonton, Alberta
- G.I. Research Institute — Vancouver, British Columbia
- McGill University Health Center — Montreal, Quebec
- Amsterdam UMC — Amsterdam,
- Erasmus University Medical Center — Holland,
- Aotearoa Clinical Trials — Papatoetoe, Auckland
- Waikato Hospital — Hamilton,
- Capital Coast and Hutt — Lower Hutt,
- Universitätsspital Zürich — Zurich,
- Norfolk and Norwich University Hospital — Norwich, Norfolk
- Cardiff and Vale University Health Board-Wales — Cardiff,
- Royal Liverpool University Hospital — Liverpool,
- St George's University of London — London,
📞 Contact the Study Coordinator
Phone: (647) 895-3016
Email: pravikumar@eupraxiapharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Eosinophilic Esophagitis
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- Efficacy of Low-Dose Topical Steroids in Maintaining Remission of Eosinophilic Esophagitis in Children — Chicago, Illinois
- A Prospective Study of the Four Food Elimination Diet for Treatment of Eosinophilic Esophagitis — Chicago, Illinois
- Dupilumab for Eosinophilic Esophagitis With Severe Strictures — Chapel Hill, North Carolina
- Cow's Milk Elimination for Treatment of Eosinophilic Esophagitis — Chicago, Illinois
- A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks — Little Rock, Arkansas
Explore by condition: All Eosinophilic Esophagitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.