Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

117

participants targeted

Target at P75+ for phase_1

Timeline

7mo left

Started Mar 2023

Typical duration for phase_1

Geographic Reach

6 countries

23 active sites

Status

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

October 19, 2022

Last Update Submit

March 17, 2026

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (6)

Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
TEAEs will be summarized by dose/cohort
52 weeks
Dose Escalation- Severity of treatment emergent adverse events (TEAEs)
TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).
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.
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.
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.
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.
24 weeks

Secondary Outcomes (19)

Dose Escalation- Peak eosinophil count (PEC)
36 weeks
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
52 weeks
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
52 weeks
Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)
36 weeks
Dose Escalation- Change from baseline in odynophagia measured on an 11 point Likert scale
52 weeks
+14 more secondary outcomes

Drug: EP-104GIOther: Matching vehicle control

Interventions

EP-104GIDRUG

Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle

EP-104GI 120 mgEP-104GI 160 mgEP-104GI 20 mgEP-104GI 30 mgEP-104GI 4 mgEP-104GI 48 mgEP-104GI 64 mgEP-104GI 8 mgEP-104GI 80 mgEP-104GI 96 mgEP-104GI Dose A or matching vehicle controlEP-104GI Dose B or matching vehicle control

Matching vehicle controlOTHER

A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.

EP-104GI Dose A or matching vehicle controlEP-104GI Dose B or matching vehicle control

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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;
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eupraxia Pharmaceuticals Inc.lead

Study Sites (23)

Campbelltown Private Hospital

Sydney, New South Wales, Australia

RECRUITING

Mater Hospital Brisbane

Brisbane, Queensland, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, Australia

RECRUITING

Coastal Digestive Health

Maroochydore, Queensland, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

Eastern Health Box Hill

Box Hill, Victoria, 3128, Australia

RECRUITING

Northern Hospital Epping

Epping, Victoria, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, Australia

RECRUITING

University of Calgary

Calgary, Alberta, Canada

RECRUITING

UoA - South Edmonton Gastroenterology Research Clinic

Edmonton, Alberta, Canada

RECRUITING

G.I. Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

RECRUITING

Amsterdam UMC

Amsterdam, 1105, Netherlands

ACTIVE NOT RECRUITING

Erasmus University Medical Center

Holland, Netherlands

RECRUITING

Aotearoa Clinical Trials

Papatoetoe, Auckland, New Zealand

RECRUITING

Waikato Hospital

Hamilton, New Zealand

RECRUITING

Capital Coast and Hutt

Lower Hutt, New Zealand

RECRUITING

Universitätsspital Zürich

Zurich, Switzerland

RECRUITING

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

RECRUITING

Cardiff and Vale University Health Board-Wales

Cardiff, United Kingdom

RECRUITING

Royal Liverpool University Hospital

Liverpool, United Kingdom

RECRUITING

St George's University of London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Mark Kowalski, MD PhD
Eupraxia Pharmaceuticals
STUDY DIRECTOR

Central Study Contacts

Pranali Ravikumar, MS

CONTACT

647-895-3016 pravikumar@eupraxiapharma.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

November 8, 2022

Study Start

March 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing: Will not share

Locations

AU(9)NL(2)CH(1)GB(4)CA(4)NZ(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (19)

Study Arms (12)

EP-104GI 4 mg

EP-104GI 8 mg

EP-104GI 20 mg

EP-104GI 30 mg

EP-104GI 48 mg

EP-104GI 64 mg

EP-104GI 80 mg

EP-104GI 96 mg

EP-104GI 120 mg

EP-104GI Dose A or matching vehicle control

EP-104GI 160 mg

EP-104GI Dose B or matching vehicle control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations