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Taking peoplePhase 1/2

Studying EP-104GI in adults with eosinophilic esophagitis

Tests the safety of EP-104GI in adults with eosinophilic esophagitis.

Key facts

Who runs it
Eupraxia Pharmaceuticals Inc.
Where
Australia, Canada, Netherlands, New Zealand, Switzerland, and United Kingdom23 sites in 6 countriesChoose a country to see its sites
Registry title
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
Status
Recruiting
Phase
Phase 1/2
People taking part
117 people, planned
Started
31 Mar 2023
Expected to end
Dec 2026
Type of study
Interventional, 12 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • EP-104GI
  • Matching vehicle control
Record updated
19 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with eosinophilic esophagitis (EoE) who have symptoms. It tests EP-104GI, injected into the food pipe wall during an endoscopy.

Age
18 Years to 75 Years
Sex
All sexes can join.
Disease stage
Symptomatic EoE (EoE that causes symptoms).
Earlier treatment
People who recently started an elimination or elemental diet cannot join. Any diet therapy must stay the same during the study. Recent use of disallowed medicines or of IV or oral antibiotics is not allowed.
Biomarker or test result
Morning blood cortisol level must be above 5 μg/dL (138 nmol/L). Women who can become pregnant need a negative pregnancy test.

Main reasons for not taking part

  • Other esophageal or gut disease, or a mouth or esophagus infection
  • Narrowing of the esophagus that blocks a standard 9-10 mm endoscope, or needing widening (dilation) within 8 weeks before screening
  • Any reason corticosteroids cannot be used, or allergy to corticosteroids or study drug ingredients
  • Pregnant, breastfeeding or planning pregnancy
  • Cancer within the past 5 years (some skin and cervical cases allowed), or alcohol or drug abuse

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

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

Who cannot take part

  • 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
  • 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)
  • Previous participation in this study and had received study treatment
  • 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
  • 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)
  • 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
  • Concomitant esophageal disease, relevant GI disease, or any condition, history, or laboratory abnormality that might interfere with 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
  • Females who are pregnant, breastfeeding, or planning to become pregnant during the study
  • Any other reason, that, in the Investigator's opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in 6 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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).

The 12 groups in the trial

  • EP-104GI 4 mgTreatment being tested

    4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 8 mgTreatment being tested

    8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 20 mgTreatment being tested

    8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 30 mgTreatment being tested

    12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 48 mgTreatment being tested

    12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 64 mgTreatment being tested

    16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 80 mgTreatment being tested

    20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 96 mgTreatment being tested

    16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI 120 mgTreatment being tested

    20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI Dose A or matching vehicle controlPlacebo, for comparison

    20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI and Matching vehicle control

  • EP-104GI 160 mgTreatment being tested

    20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI

  • EP-104GI Dose B or matching vehicle controlPlacebo, for comparison

    20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.

    Treatment: EP-104GI and Matching vehicle control

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
Plain-language title
Studying EP-104GI in adults with eosinophilic esophagitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT05608681, who can take part
Record updated
19 March 2026