Testing EP-104GI against a placebo for eosinophilic esophagitis
Official title: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)
- Phase 1
- 12 groups
- Sites in Calgary, Edmonton and 2 more cities
- Recruiting
Interventions
- Medication
EP-104GI
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
- Other intervention
Matching vehicle control
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
UoA - South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta
- Recruiting
G.I. Research Institute
Vancouver, British Columbia
- Recruiting
McGill University Health Center
Montreal, Quebec
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Symptomatic EoE;
- +Willing and able to adhere to study-related procedures and visit schedule;
- +Willing and able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Criteria for crossoverCrossoverEach participant receives both treatments in turn, in a set order.Read more → to EP 104GI from vehicle controlControl groupThe group a new treatment is measured against.Read more → (randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → or have other safety issue
- +For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study;
Exclusion
- −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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or the need for dilation prior to EGD at BaselineBaselineYour starting measurements, taken before treatment begins.Read more →;
- −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);
- −or have other safety issue
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −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;
- −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;
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more → ;
- −Previous participation in this study and had received study treatment;
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, unfavorably alters participant risk, confounds results, or prevents the participant from complying with study requirements.
- −Females who are pregnant, breastfeeding, or planning to become pregnant during the study;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 12 groups in this study.
Groups A, B, C, D, E, F, G, H, I and K receive EP-104GI.
Registry label: A: EP-104GI 4 mg · B: EP-104GI 8 mg · C: EP-104GI 20 mg · D: EP-104GI 30 mg · E: EP-104GI 48 mg · F: EP-104GI 64 mg · G: EP-104GI 80 mg · H: EP-104GI 96 mg · I: EP-104GI 120 mg · K: EP-104GI 160 mg
Groups J and L, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive EP-104GI and Matching vehicle controlControl groupThe group a new treatment is measured against.Read more →.
Registry label: J: EP-104GI Dose A or matching vehicle control · L: EP-104GI Dose B or matching vehicle control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 117 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 52 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →- Incidence of treatment emergent adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs) — measured over 52 weeks.
Dose Escalation- Severity of treatment emergent adverse events (TEAEs) — measured over 52 weeks.
Dose Escalation- Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in morning serum cortisol levels — measured over 52 weeks.
Dose Escalation- Plasma concentrations of fluticasone propionate — measured over 108 weeks.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05608681 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About EP-104GIDrug
Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Matching vehicle controlOther
A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 52 weeks.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 117 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.