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New injection could ease swallowing for eosinophilic esophagitis patients

NCT ID NCT05608681

Disease control Sponsor: Eupraxia Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new injectable steroid called EP-104GI for adults with eosinophilic esophagitis, a condition where the esophagus becomes inflamed and makes swallowing difficult. The drug is given during an endoscopy and is designed to release medication slowly over time. The trial involves about 160 participants and will check for safety, side effects, and whether it improves symptoms and reduces inflammation in the esophagus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EP-104GI (extended-release fluticasone propionate injection)
What this could lead to
If successful, this could provide a longer-lasting treatment option for eosinophilic esophagitis, reducing the need for daily medication.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The drug is a steroid, which can have side effects like adrenal suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 117 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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): 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 criteria or have other safety issue Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC

    ACTIVE_NOT_RECRUITING

    Amsterdam, 1105, Netherlands

  • Aotearoa Clinical Trials

    RECRUITING

    Papatoetoe, Auckland, New Zealand

  • Campbelltown Private Hospital

    RECRUITING

    Sydney, New South Wales, Australia

  • Capital Coast and Hutt

    RECRUITING

    Lower Hutt, New Zealand

  • Cardiff and Vale University Health Board-Wales

    RECRUITING

    Cardiff, United Kingdom

  • Coastal Digestive Health

    RECRUITING

    Maroochydore, Queensland, Australia

  • Eastern Health Box Hill

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Erasmus University Medical Center

    RECRUITING

    Holland, Netherlands

  • G.I. Research Institute

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Mater Hospital Brisbane

    RECRUITING

    Brisbane, Queensland, Australia

  • McGill University Health Center

    RECRUITING

    Montreal, Quebec, Canada

  • Norfolk and Norwich University Hospital

    RECRUITING

    Norwich, Norfolk, United Kingdom

  • Northern Hospital Epping

    RECRUITING

    Epping, Victoria, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Brisbane, Queensland, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, Australia

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, Australia

  • St George's University of London

    RECRUITING

    London, United Kingdom

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • University of Calgary

    RECRUITING

    Calgary, Alberta, Canada

  • Universitätsspital Zürich

    RECRUITING

    Zurich, Switzerland

  • UoA - South Edmonton Gastroenterology Research Clinic

    RECRUITING

    Edmonton, Alberta, Canada

  • Waikato Hospital

    RECRUITING

    Hamilton, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.