A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
NCT ID: NCT05608681
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
117 participants
INTERVENTIONAL
2023-03-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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EP-104GI 4 mg
4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 8 mg
8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 20 mg
8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 30 mg
12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 48 mg
12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 64 mg
16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 80 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 96 mg
16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI 120 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI Dose A or matching vehicle control
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
EP-104GI 160 mg
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
EP-104GI Dose B or matching vehicle control
20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Interventions
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EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Eupraxia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Kowalski, MD PhD
Role: STUDY_DIRECTOR
Eupraxia Pharmaceuticals
Locations
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Campbelltown Private Hospital
Sydney, New South Wales, Australia
Mater Hospital Brisbane
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Coastal Digestive Health
Maroochydore, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Eastern Health Box Hill
Box Hill, Victoria, Australia
Northern Hospital Epping
Epping, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
G.I. Research Institute
Vancouver, British Columbia, Canada
McGill University Health Center
Montreal, Quebec, Canada
Amsterdam UMC
Amsterdam, , Netherlands
Aotearoa Clinical Trials
Papatoetoe, Auckland, New Zealand
Capital Coast and Hutt
Lower Hutt, , New Zealand
Universitätsspital Zürich
Zurich, , Switzerland
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Cardiff and Vale University Health Board-Wales
Cardiff, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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EP-104IAR-102 (RESOLVE)
Identifier Type: -
Identifier Source: org_study_id
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