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

Last updated: March 17, 2026
Sponsor: Eupraxia Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

EP-104IAR

EP-104GI

Matching vehicle control

Clinical Study ID

NCT05608681
EP-104IAR-102 (RESOLVE)
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic EoE;

  • For women of childbearing potential, a negative pregnancy test and willing to use ahighly 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 criteriaor have other safety issue

Exclusion

Exclusion Criteria:

  • Concomitant esophageal disease, relevant GI disease, or any condition, history, orlaboratory 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 EGDor biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mmendoscope, stricture requiring dilation within 8 weeks prior to Screening, or theneed for dilation prior to EGD at Baseline;

  • Any condition for which the use of corticosteroids is contraindicated (Participantswith well controlled non-insulin dependent diabetes are permitted);

  • Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, orocular herpes simplex. Or recent use of IV or oral antibiotics;

  • Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients inthe investigational medicinal product, including carboxymethyl cellulose, andpolysorbate 80, or to the ingredients in Synacthen / cosyntropin (used in the ACTHstimulation test);

  • Recent use of disallowed medications, or unwillingness to not use disallowedmedications during the study;

  • Recent initiation of a elimination or elemental diet (dietary therapy must remainstable 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 thestudy;

  • Malignancies or history of malignancy within prior 5 years, except for treated orexcised 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 altersparticipant risk, confounds results, or prevents the participant from complying withstudy requirements.

Study Design

Total Participants: 117
Treatment Group(s): 3
Primary Treatment: EP-104IAR
Phase: 1/2
Study Start date:
March 31, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Campbelltown Private Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Campbelltown Private Hospital

    Sydney 2147714, New South Wales 2155400
    Australia

    Site Not Available

  • Mater Hospital Brisbane

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Coastal Digestive Health

    Maroochydore, Queensland
    Australia

    Active - Recruiting

  • Mater Hospital Brisbane

    Brisbane 2174003, Queensland 2152274
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane 2174003, Queensland 2152274
    Australia

    Site Not Available

  • Coastal Digestive Health

    Maroochydore 2207268, Queensland 2152274
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide 2078025, South Australia 2061327
    Australia

    Site Not Available

  • Eastern Health Box Hill

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Northern Hospital Epping

    Epping, Victoria
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria
    Australia

    Active - Recruiting

  • Eastern Health Box Hill

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Site Not Available

  • Northern Hospital Epping

    Epping 2167279, Victoria 2145234
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville 2153770, Victoria 2145234
    Australia

    Site Not Available

  • University of Calgary

    Calgary, Alberta
    Canada

    Active - Recruiting

  • UoA - South Edmonton Gastroenterology Research Clinic

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • University of Calgary

    Calgary 5913490, Alberta 5883102
    Canada

    Site Not Available

  • UoA - South Edmonton Gastroenterology Research Clinic

    Edmonton 5946768, Alberta 5883102
    Canada

    Site Not Available

  • G.I. Research Institute

    Vancouver, British Columbia V6Z 2K5
    Canada

    Active - Recruiting

  • G.I. Research Institute

    Vancouver 6173331, British Columbia 5909050 V6Z 2K5
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal, Quebec
    Canada

    Active - Recruiting

  • McGill University Health Center

    Montréal, Quebec
    Canada

    Site Not Available

  • McGill University Health Center

    Montreal 6077243, Quebec 6115047
    Canada

    Site Not Available

  • Amsterdam UMC

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • Amsterdam UMC

    Amsterdam 2759794, 1105
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Holland,
    Netherlands

    Active - Recruiting

  • Aotearoa Clinical Trials

    Papatoetoe, Auckland
    New Zealand

    Active - Recruiting

  • Aotearoa Clinical Trials

    Papatoetoe 6232008, Auckland 2193734
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton,
    New Zealand

    Active - Recruiting

  • Capital Coast and Hutt

    Lower Hutt,
    New Zealand

    Active - Recruiting

  • Capital Coast and Hutt

    Lower Hutt 2188164,
    New Zealand

    Site Not Available

  • Universitätsspital Zürich

    Zurich,
    Switzerland

    Active - Recruiting

  • Universitätsspital Zürich

    Zurich 2657896,
    Switzerland

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk
    United Kingdom

    Active - Recruiting

  • Norfolk and Norwich University Hospital

    Norwich 2641181, Norfolk
    United Kingdom

    Site Not Available

  • Cardiff and Vale University Health Board-Wales

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Cardiff and Vale University Health Board-Wales

    Cardiff 2653822,
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool,
    United Kingdom

    Active - Recruiting

  • St George's University of London

    London,
    United Kingdom

    Active - Recruiting

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