Eosinophilic EsophagitisPhase 1/2RESOLVENCT05608681
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
A Phase 1/2 study testing EP-104GI in people with Eosinophilic Esophagitis, run by Eupraxia Pharmaceuticals Inc. at 23 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- EP-104GI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 31 Mar 2023to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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);
Show all 18Show fewer
- 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.
Trial locations and contacts
23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 6 countries
Australia9 sites, 9 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
Joshua Zobel, joshua.zobel@sa.gov.au
Nam Nguyen, MD
- Recruiting
Eastern Health Box Hill
Box Hill, Victoria, 3128
Emma Dimitri, emma.dimitri@monash.edu
Sanjay Nandurkar, MD
- Recruiting
Mater Hospital Brisbane
Brisbane, Queensland
Sharyn Grossman, Sharyn.Grossman@mater.org.au
Yoon-Kyo An
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland
Teressa Hansen, Teressa.Hansen@health.qld.gov.au
Gerald Holtmann, MD
- Recruiting
Northern Hospital Epping
Epping, Victoria
Gloria Sepe, Gloria.sepe@nh.org.au
Mayur Garg
- Recruiting
Coastal Digestive Health
Maroochydore, Queensland
Charlotte Early, charlotte@cdhresearch.com.au
Hans Seltenreich
- Recruiting
The Alfred Hospital
Melbourne, Victoria
Jean Zhang, jean.zhang@alfred.org.au
Rebecca Burgell
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria
Irene Bell, Irene.bell@mh.org.au
Nicholas Hannah
- Recruiting
Campbelltown Private Hospital
Sydney, New South Wales
Rashmi Gamage, rashmi@sydneyclinicaltrials.com.au
Vincent Ho, MD
Canada4 sites, 4 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
shaalan@ualberta.ca
Milli Gupta
- Recruiting
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta
Claire Graham, claire@percuro.ca
Jesse Siffledeen
- Recruiting
McGill University Health Center
Montreal, Quebec
Kim Azem, nurse@cliniqueimd.com
Waqqas Afif, MD
- Recruiting
G.I. Research Institute
Vancouver, British Columbia, V6Z 2K5
Maria Ancheta-Schmit, marias@giribc.com
Hin Hin Ko, MD
United Kingdom4 sites, 4 recruiting
- Recruiting
Cardiff and Vale University Health Board-Wales
Cardiff
Maryanne Bray, Maryanne.Bray3@wales.nhs.uk
Hasan N Haboubi
- Recruiting
Royal Liverpool University Hospital
Liverpool
CLAIRE BURSTON, claire.burston@liverpoolft.nhs.uk
Andrew Moore
- Recruiting
St George's University of London
London
Timtayo Oke, timtayo.oke@stgeorges.nhs.uk
Jamal Hayat
- Recruiting
Norfolk and Norwich University Hospital
Norwich, Norfolk
Sally Ann Copsey, Sally-Ann.Copsey@nnuh.nhs.uk
Ian Beales
New Zealand3 sites, 3 recruiting
- Recruiting
Waikato Hospital
Hamilton
Heather Logan, heather.logan@waikatodhb.health.nz
Frank Weilert
- Recruiting
Capital Coast and Hutt
Lower Hutt
Ana Enriquez, ana.enriquez@ccdhb.org.nz
Stephen Inns
- Recruiting
Aotearoa Clinical Trials
Papatoetoe, Auckland
Indu Muniraj, Indu.Muniraj@aotearoatrials.nz
Tien Huey Lim
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Amsterdam UMC
Amsterdam, 1105
- Recruiting
Erasmus University Medical Center
Holland
Milko van Langen, m.vanlangen@erasmusmc.nl
Peter Siersema
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich
Sabine Burk, sabine.burk@usz.ch
Christopher Schlag
About this study
Official title: 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).
- Conditions
- Eosinophilic Esophagitis
- Being tested
- EP-104GI, Matching vehicle control
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-104GIDrug
Extended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle controlOther
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
| Study group | Role | What they receive |
|---|---|---|
| EP-104GI 4 mg | Experimental | 4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 8 mg | Experimental | 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 20 mg | Experimental | 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 30 mg | Experimental | 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 48 mg | Experimental | 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 64 mg | Experimental | 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 80 mg | Experimental | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 96 mg | Experimental | 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI 120 mg | Experimental | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI Dose A or matching vehicle control | Placebo comparator | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI; Other: Matching vehicle control |
| EP-104GI 160 mg | Experimental | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI |
| EP-104GI Dose B or matching vehicle control | Placebo comparator | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. Receives: Drug: EP-104GI; Other: Matching vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
TEAEs will be summarized by dose/cohort
Measured: 52 weeks
Dose Escalation- Severity of treatment emergent adverse events (TEAEs)
TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).
Measured: 52 weeks
Dose Escalation- Change from baseline in morning serum cortisol levels
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.
Measured: 52 weeks
Dose Escalation- Plasma concentrations of fluticasone propionate
Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
Measured: 108 weeks
Dose Escalation- Change from baseline in physical examination results, BMI and weight change.
Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.
Measured: 12 weeks
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)
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.
Measured: 24 weeks
Secondary outcomes (19)
Dose Escalation- Peak eosinophil count (PEC)
Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
Measured: 36 weeks
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
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.
Measured: 52 weeks
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
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.
Measured: 52 weeks
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)
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.
Measured: 36 weeks
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale
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.
Measured: 52 weeks
Dose Escalation- Change from baseline in EoE Histology Scoring System (EoEHSS) score
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.
Measured: 36 weeks
Randomised Dose Optimization- Change from baseline in the Straumann Dysphagia Index (SDI) score
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.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days"
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?
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EoE IQ)
The EoE-IQ is a validated PRO instrument consisting of 11 questions assessing the impact of EoE on health related quality of life.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Change (PGIC)
The PGIC reflects a participant's belief about the efficacy of treatment on a 7 point scale rating on a 4 point scale.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Severity (PGIS)
The PGIS reflects a participant's belief about the efficacy of treatment based on severity ranging from none to very severe.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in peak eosinophil count (PEC)
Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
Measured: 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)
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.
Measured: 52 weeks
Randomised Dose Optimization- Change in endoscopist's global impression of severity
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
Measured: 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
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.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in morning serum cortisol levels
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.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in vital signs (temperature, blood pressure, pulse, and respiratory rate) results
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.
Measured: 52 weeks
Randomised Dose Optimization- Change from baseline in physical examination results, BMI and weight change.
Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.
Measured: 52 weeks
Randomised Dose Optimization- Plasma concentrations of fluticasone propionate
Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
Measured: 108 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start31 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kowalski, MD PhD, Study director, Eupraxia Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608681
- Sponsor's protocol ID
- EP-104IAR-102 (RESOLVE)
- Acronym
- RESOLVE
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
- ClinicalTrials.gov ID
- NCT05608681
- Acronym / sponsor ID
- RESOLVE / EP-104IAR-102 (RESOLVE)
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| EP-104GI 4 mg | Experimental | Drug: EP-104GI4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 8 mg | Experimental | Drug: EP-104GI8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 20 mg | Experimental | Drug: EP-104GI8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 30 mg | Experimental | Drug: EP-104GI12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 48 mg | Experimental | Drug: EP-104GI12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 64 mg | Experimental | Drug: EP-104GI16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 80 mg | Experimental | Drug: EP-104GI20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 96 mg | Experimental | Drug: EP-104GI16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 120 mg | Experimental | Drug: EP-104GI20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI Dose A or matching vehicle control | Placebo comparator | Drug: EP-104GI, Other: Matching vehicle control20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 160 mg | Experimental | Drug: EP-104GI20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI Dose B or matching vehicle control | Placebo comparator | Drug: EP-104GI, Other: Matching vehicle control20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP-104GIExtended-release fluticasone propionate [FP] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle | Drug | EP-104GI 120 mg, EP-104GI 160 mg, EP-104GI 20 mg, EP-104GI 30 mg, EP-104GI 4 mg, EP-104GI 48 mg, EP-104GI 64 mg, EP-104GI 8 mg, EP-104GI 80 mg, EP-104GI 96 mg, EP-104GI Dose A or matching vehicle control, EP-104GI Dose B or matching vehicle control |
| Matching vehicle controlA sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder. | Other | EP-104GI Dose A or matching vehicle control, EP-104GI Dose B or matching vehicle control |
Primary outcome
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
Time frame: 52 weeks
TEAEs will be summarized by dose/cohort
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).
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.
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.
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.
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.
19 secondary outcomes
Dose Escalation- Peak eosinophil count (PEC)
Time frame: 36 weeks
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
Time frame: 52 weeks
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
Time frame: 52 weeks
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)
Time frame: 36 weeks
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale
Time frame: 52 weeks
Dose Escalation- Change from baseline in EoE Histology Scoring System (EoEHSS) score
Time frame: 36 weeks
Randomised Dose Optimization- Change from baseline in the Straumann Dysphagia Index (SDI) score
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in the Dysphagia symptom questionnaire (DSQ) v4.0 and "Dysphagia days"
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in the Eosinophilic Esophagitis Impact Questionnaire (EoE IQ)
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Change (PGIC)
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in the Patient Global Impression of Severity (PGIS)
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in peak eosinophil count (PEC)
Time frame: 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
Randomised Dose Optimization- Change in endoscopist's global impression of severity
Time frame: 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
Randomised Dose Optimization- Change from baseline in morning serum cortisol levels
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in vital signs (temperature, blood pressure, pulse, and respiratory rate) results
Time frame: 52 weeks
Randomised Dose Optimization- Change from baseline in physical examination results, BMI and weight change.
Time frame: 52 weeks
Randomised Dose Optimization- Plasma concentrations of fluticasone propionate
Time frame: 108 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Kowalski, MD PhD study director
Eupraxia Pharmaceuticals
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EP-104GI in people with Eosinophilic Esophagitis, run by Eupraxia Pharmaceuticals Inc. at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Australia, Canada, United Kingdom, New Zealand, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pranali Ravikumar, MS (647-895-3016, pravikumar@eupraxiapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs) (time frame: 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.