Actively Recruiting
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
Led by Eupraxia Pharmaceuticals Inc. · Updated on 2026-03-19
117
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes EP-104GI, an extended-release fluticasone propionate injectable suspension, in adults with eosinophilic esophagitis (EoE). This Phase 1b/2 study aims to understand the local effects of EP-104GI on disease activity using endoscopic and tissue assessments. About 160 participants will be enrolled across dose escalation and randomized dose optimization phases to identify recommended doses and assess outcomes. Participants will receive EP-104GI or a matching vehicle control through submucosal injections during an esophagogastroduodenoscopy (EGD) procedure at the baseline dosing visit. The dose escalation phase will enroll 27 to 33 participants in different dose cohorts, while the randomized phase will assign about 120 participants to one of two dose levels or vehicle control. Those on vehicle control may switch to EP-104GI after 24 weeks if eligible. Additional substudies may include extended pharmacokinetic follow-up. During the study, participants will attend 8 to 10 visits over approximately 52 weeks, with some having up to 4 extra visits extending to 108 weeks. They will undergo 3 to 5 EGD procedures with biopsies to monitor disease changes and safety. Blood and urine samples will be collected for laboratory tests and drug level measurement. Questionnaires will track symptoms like difficulty swallowing and pain when swallowing. Safety and physical health will be regularly assessed throughout the trial.
CONDITIONS
Brief Title
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with symptomatic eosinophilic esophagitis (EoE)
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control until study end
- Willing and able to follow study procedures and visit schedule
- Able to provide informed consent
- For crossover from vehicle control, participants must have completed Week 24 of randomized dose optimization and have no safety concerns
You will not qualify if you...
- Presence of other esophageal or relevant gastrointestinal diseases
- Oral or esophageal infections of any type
- Dental or throat conditions that prevent normal eating
- Severe esophageal motility disorders besides EoE
- Contraindications or increased risks related to endoscopy or biopsy procedures
- Narrowing or strictures of the esophagus that prevent standard endoscopy
- Conditions contraindicating corticosteroid use (except well-controlled non-insulin dependent diabetes)
- Active or recent systemic infections or recent use of IV/oral antibiotics
- Allergies or intolerance to corticosteroids or study product ingredients
- Recent use of disallowed medications or unwillingness to avoid them during the study
- Recent start of elimination or elemental diet
- Low morning serum cortisol levels (≤ 5 µg/dL)
- Significant abnormal lab values
- Recent or planned participation in another interventional trial
- Previous participation in this study with study treatment
- Pregnancy, breastfeeding, or planning pregnancy during study
- History of malignancy within 5 years except certain treated skin or cervical cancers
- History of substance abuse
- Any other condition judged by the investigator to increase risk or interfere with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dosing visit with effects monitored up to 52 weeks
Participants receive 4 to 20 submucosal injections of EP-104GI or matching vehicle control administered during an endoscopic procedure at the baseline/dosing visit.
1 baseline/dosing visit and multiple follow-up visits over 52 weeks
Duration - Up to 108 weeks
Participants are monitored for safety, pharmacokinetics, and efficacy outcomes including adverse events, cortisol levels, and esophageal assessments.
Multiple follow-up visits up to 108 weeks
Trial Site Locations
Total: 23 locations
1
Campbelltown Private Hospital
Sydney, New South Wales, Australia
Actively Recruiting
2
Mater Hospital Brisbane
Brisbane, Queensland, Australia
Actively Recruiting
3
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Actively Recruiting
4
Coastal Digestive Health
Maroochydore, Queensland, Australia
Actively Recruiting
5
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Actively Recruiting
6
Eastern Health Box Hill
Box Hill, Victoria, Australia, 3128
Actively Recruiting
7
Northern Hospital Epping
Epping, Victoria, Australia
Actively Recruiting
8
The Alfred Hospital
Melbourne, Victoria, Australia
Actively Recruiting
9
Royal Melbourne Hospital
Parkville, Victoria, Australia
Actively Recruiting
10
University of Calgary
Calgary, Alberta, Canada
Actively Recruiting
11
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
Actively Recruiting
12
G.I. Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Actively Recruiting
13
McGill University Health Center
Montreal, Quebec, Canada
Actively Recruiting
14
Amsterdam UMC
Amsterdam, Netherlands, 1105
Active, Not Recruiting
15
Erasmus University Medical Center
Holland, Netherlands
Actively Recruiting
16
Aotearoa Clinical Trials
Papatoetoe, Auckland, New Zealand
Actively Recruiting
17
Waikato Hospital
Hamilton, New Zealand
Actively Recruiting
18
Capital Coast and Hutt
Lower Hutt, New Zealand
Actively Recruiting
19
Universitätsspital Zürich
Zurich, Switzerland
Actively Recruiting
20
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Actively Recruiting
21
Cardiff and Vale University Health Board-Wales
Cardiff, United Kingdom
Actively Recruiting
22
Royal Liverpool University Hospital
Liverpool, United Kingdom
Actively Recruiting
23
St George's University of London
London, United Kingdom
Actively Recruiting
Research Team
P
Pranali Ravikumar, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
12
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here