A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (RESOLVE)

March 17, 2026 updated by: Eupraxia Pharmaceuticals Inc.

A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia
      • Brisbane, Queensland, Australia
      • Maroochydore, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Nam Nguyen, MD
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Eastern Health Box Hill
        • Contact:
        • Principal Investigator:
          • Sanjay Nandurkar, MD
      • Epping, Victoria, Australia
        • Recruiting
        • Northern Hospital Epping
        • Principal Investigator:
          • Mayur Garg
        • Contact:
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Rebecca Burgell
      • Parkville, Victoria, Australia
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
        • Principal Investigator:
          • Nicholas Hannah
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • University of Calgary
        • Contact:
        • Principal Investigator:
          • Milli Gupta
      • Edmonton, Alberta, Canada
        • Recruiting
        • UoA - South Edmonton Gastroenterology Research Clinic
        • Principal Investigator:
          • Jesse Siffledeen
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • G.I. Research Institute
        • Principal Investigator:
          • Hin Hin Ko, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health Center
        • Principal Investigator:
          • Waqqas Afif, MD
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Active, not recruiting
        • Amsterdam UMC
      • Holland, Netherlands
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
        • Principal Investigator:
          • Peter Siersema
  • New Zealand
      • Hamilton, New Zealand
      • Lower Hutt, New Zealand
        • Recruiting
        • Capital Coast and Hutt
        • Principal Investigator:
          • Stephen Inns
        • Contact:
    • Auckland
      • Papatoetoe, Auckland, New Zealand
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • UniversitätsSpital Zürich
        • Contact:
        • Principal Investigator:
          • Christopher Schlag
  • United Kingdom
      • Cardiff, United Kingdom
        • Recruiting
        • Cardiff and Vale University Health Board-Wales
        • Contact:
        • Principal Investigator:
          • Hasan N Haboubi
      • Liverpool, United Kingdom
      • London, United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Principal Investigator:
          • Ian Beales
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic EoE;
  • For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study;
  • Willing and able to adhere to study-related procedures and visit schedule;
  • Willing and able to provide informed consent.

Criteria for crossover to EP 104GI from vehicle control (randomized dose optimization portion):

  1. Has completed the randomized dose optimization portion of the trial to Week 24, inclusive
  2. Without safety concerns for receiving EP 104GI ie, does not meet exclusion criteria or have other safety issue

Exclusion Criteria:

  • Concomitant esophageal disease, relevant GI disease, or any condition, history, or laboratory abnormality that might interfere with the study;
  • Oral or esophageal mucosal infection of any type (bacterial, viral, or fungal);
  • Oropharyngeal or dental conditions that prevents normal eating;
  • Severe esophageal motility disorders other than EoE;
  • Contraindication to or factors that substantially increase risks associated with EGD or biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mm endoscope, stricture requiring dilation within 8 weeks prior to Screening, or the need for dilation prior to EGD at Baseline;
  • Any condition for which the use of corticosteroids is contraindicated (Participants with well controlled non-insulin dependent diabetes are permitted);
  • Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. Or recent use of IV or oral antibiotics;
  • Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients in the investigational medicinal product, including carboxymethyl cellulose, and polysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTH stimulation test);
  • Recent use of disallowed medications, or unwillingness to not use disallowed medications during the study;
  • Recent initiation of a elimination or elemental diet (dietary therapy must remain stable throughout the study);
  • Morning serum cortisol level ≤ 5 μg/dL (138 nmol/L);
  • Clinically significant abnormal laboratory values;
  • Recent or currently planned participation in another interventional trial ;
  • Previous participation in this study and had received study treatment;
  • Females who are pregnant, breastfeeding, or planning to become pregnant during the study;
  • Malignancies or history of malignancy within prior 5 years, except for treated or excised non-metastatic BCC, SCC of the skin, or cervical carcinoma in situ;
  • History of alcohol or drug abuse;
  • Any other reason, that, in the Investigator's opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EP-104GI 4 mg
4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 8 mg
8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 20 mg
8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 30 mg
12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 48 mg
12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 64 mg
16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 80 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 96 mg
16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Experimental: EP-104GI 120 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Placebo Comparator: EP-104GI Dose A or matching vehicle control
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Other: Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Experimental: EP-104GI 160 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Placebo Comparator: EP-104GI Dose B or matching vehicle control
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Drug: EP-104GI
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Other: Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randomised Dose Optimization- Change from baseline in EoEHSS grade and stage scored in 3 regions of the esophagus within the injection area (proximal, mid, distal)
Time Frame: 24 weeks
The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
24 weeks
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
Time Frame: 52 weeks
TEAEs will be summarized by dose/cohort
52 weeks
Dose Escalation- Severity of treatment emergent adverse events (TEAEs)
Time Frame: 52 weeks
TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).
52 weeks
Dose Escalation- Change from baseline in morning serum cortisol levels
Time Frame: 52 weeks
Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency.
52 weeks
Dose Escalation- Plasma concentrations of fluticasone propionate
Time Frame: 108 weeks
Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
108 weeks
Dose Escalation- Change from baseline in physical examination results, BMI and weight change.
Time Frame: 12 weeks
Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randomised Dose Optimization- Change from baseline in the Straumann Dysphagia Index (SDI) score
Time Frame: 52 weeks
The SDI is a patient-reported outcome measure of dysphagia with a 7-day recall period. The SDI assesses the frequency and intensity of dysphagia on two separate 5-point and 6-point scales. Total SDI scores are calculated by adding the two sub-scores (range, 0-9), with a higher total score indicating more severe dysphagia.
52 weeks
Randomised Dose Optimization- Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days"
Time Frame: 52 weeks
The DSQ is assessed daily over a period of 14 days and comprises four questions; one question on whether the participant has eaten solid food and three questions on the presence and severity of EoE dysphagia."Dysphagia Days" is defined as the number of days with a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest?
52 weeks
Randomised Dose Optimization- Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EoE IQ)
Time Frame: 52 weeks
The EoE-IQ is a validated PRO instrument consisting of 11 questions assessing the impact of EoE on health related quality of life.
52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Change (PGIC)
Time Frame: 52 weeks
The PGIC reflects a participant's belief about the efficacy of treatment on a 7 point scale rating on a 4 point scale.
52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Severity (PGIS)
Time Frame: 52 weeks
The PGIS reflects a participant's belief about the efficacy of treatment based on severity ranging from none to very severe.
52 weeks
Randomised Dose Optimization- Change from baseline in peak eosinophil count (PEC)
Time Frame: 52 weeks
Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
52 weeks
Randomised Dose Optimization- Change from baseline in the EoE Endoscopic Reference Score (EREFS) in 3 regions of the esophagus within the injection area (proximal, mid, distal)
Time Frame: 52 weeks
Endoscopic Reference Score (EREFS) scoring system is used to determine the severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. The total EREFS is calculated by summing the grades of the 5 individual endoscopic items (range, 0 to 9), with higher scores indicating more severe endoscopic disease.
52 weeks
Randomised Dose Optimization- Change in endoscopist's global impression of severity
Time Frame: 52 weeks
The PGIC reflects a participant's belief about the efficacy of treatment on a 7 point scale rating overall improvement; the PGIS reflects a participant's belief about the severity of their symptoms on a 4 point scale
52 weeks
Randomised Dose Optimization- Change from baseline in EoE Histology Scoring System (EoEHSS) score in 3 regions of the esophagus within the injection area (proximal, mid, distal), excluding Week 24 as this is the primary endpoint
Time Frame: 52 weeks
The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
52 weeks
Randomised Dose Optimization- Change from baseline in morning serum cortisol levels
Time Frame: 52 weeks
Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency.
52 weeks
Randomised Dose Optimization- Change from baseline in vital signs (temperature, blood pressure, pulse, and respiratory rate) results
Time Frame: 52 weeks
Vital signs (temperature, blood pressure, pulse, and respiratory rate) results will be summarized by dose/cohort and over time and compared to pre-dose values.
52 weeks
Randomised Dose Optimization- Change from baseline in physical examination results, BMI and weight change.
Time Frame: 52 weeks
Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.
52 weeks
Dose Escalation- Peak eosinophil count (PEC)
Time Frame: 36 weeks
Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
36 weeks
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
Time Frame: 52 weeks
The SDI is a patient-reported outcome measure of dysphagia with a 7-day recall period. The SDI assesses the frequency and intensity of dysphagia on two separate 5-point and 6-point scales. Total SDI scores are calculated by adding the two sub-scores (range, 0-9), with a higher total score indicating more severe dysphagia.
52 weeks
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
Time Frame: 52 weeks
The participant will assess the severity of their dysphagia symptoms (troubles to swallow) over the previous 7-days using an 11-point Likert scale where 0 = no trouble and 10 = most severe trouble swallowing.
52 weeks
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Time Frame: 36 weeks
Endoscopic Reference Score (EREFS) scoring system is used to determine the severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. The total EREFS is calculated by summing the grades of the 5 individual endoscopic items (range, 0 to 9), with higher scores indicating more severe endoscopic disease.
36 weeks
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale
Time Frame: 52 weeks
The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
52 weeks
Dose Escalation- Change from baseline in EoE Histology Scoring System (EoEHSS) score
Time Frame: 36 weeks
The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
36 weeks
Randomised Dose Optimization- Plasma concentrations of fluticasone propionate
Time Frame: 108 weeks
Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
108 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eupraxia Pharmaceuticals Inc.

Investigators

  • Study Director: Mark Kowalski, MD PhD, Eupraxia Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-104IAR-102 (RESOLVE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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