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EP-104IAR for EoE (RESOLVE Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Eupraxia Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

RESOLVE Trial Summary

This trial studies EP-104IAR to treat eosinophilic esophagitis (EoE). It will explore safety, tolerability and effects on disease activity over 32 weeks.

Who is the study for?
Adults with eosinophilic esophagitis (EoE) who can consent and follow the study plan. Women must test negative for pregnancy and use birth control. Excluded are those with other esophageal diseases, infections, severe swallowing disorders, risks from endoscopy or biopsy procedures, recent steroid contraindications, certain medication use, dietary changes or another trial participation.Check my eligibility
What is being tested?
The safety and effects of varying doses of EP-104IAR in adults with EoE are being tested. Up to 24 participants will receive the drug during an endoscopic procedure over about 32 weeks. The study includes blood/urine tests for safety monitoring and questionnaires on swallowing difficulties.See study design
What are the potential side effects?
While specific side effects aren't listed here, the trial monitors for adverse reactions through regular blood and urine tests after administering EP-104IAR via endoscopy.

RESOLVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in morning serum cortisol levels
Therapeutic procedure
Plasma
+1 more
Secondary outcome measures
Change from baseline in EoE Histology Scoring System (EoEHSS) score
Deglutition Disorders
Change from baseline in odynophagia measured on an 11 point Likert scale
+3 more

RESOLVE Trial Design

8Treatment groups
Experimental Treatment
Group I: EP-104IAR 8 mgExperimental Treatment1 Intervention
8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group II: EP-104IAR 40 mgExperimental Treatment1 Intervention
16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group III: EP-104IAR 4 mgExperimental Treatment1 Intervention
4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group IV: EP-104IAR 30 mgExperimental Treatment1 Intervention
12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group V: EP-104IAR 20 mgExperimental Treatment1 Intervention
8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group VI: EP-104IAR 16 mgExperimental Treatment1 Intervention
16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group VII: EP-104IAR 12 mgExperimental Treatment1 Intervention
12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Group VIII: EP-104IAR 10 mgExperimental Treatment1 Intervention
4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EP-104IAR
2016
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Eupraxia Pharmaceuticals Inc.Lead Sponsor
2 Previous Clinical Trials
350 Total Patients Enrolled
Amanda MaloneStudy DirectorEupraxia Pharmaceuticals
1 Previous Clinical Trials
318 Total Patients Enrolled
Amanda Malone, PhDStudy DirectorEupraxia Pharmaceuticals

Media Library

EP-104IAR (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05608681 — Phase 1 & 2
Eosinophilic Esophagitis Research Study Groups: EP-104IAR 4 mg, EP-104IAR 8 mg, EP-104IAR 12 mg, EP-104IAR 16 mg, EP-104IAR 10 mg, EP-104IAR 20 mg, EP-104IAR 30 mg, EP-104IAR 40 mg
Eosinophilic Esophagitis Clinical Trial 2023: EP-104IAR Highlights & Side Effects. Trial Name: NCT05608681 — Phase 1 & 2
EP-104IAR (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608681 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this treatment program available for individuals at this time?

"As indicated on clinicaltrials.gov, this experiment is in the process of seeking participants. It was first uploaded to the website on March 31st 2023 and has been modified as recently as May 17th 2023."

Answered by AI

What results is this research endeavor aiming to generate?

"According to the data furnished by Eupraxia Pharmaceuticals Inc., this clinical trial's main objective, assessed over a period of 12 weeks, is measuring fluctuations in morning serum cortisol levels. Secondary outcomes recorded include changes from baseline on the Straumann Dysphagia Index (SDI), which gauges dysphagia frequency and intensity via two independent 5-point and 6-point scales; dysphagia severity based on an 11 point Likert scale ranging between 0(no trouble) - 10(most severe); and odynophagia pain relief quantified through another 11 point Likert Scale calibrated from 0(no"

Answered by AI

Is there an opportunity to partake in this experiment?

"This study seeks 24 candidates, aged between 18 and 75, suffering from eosinophilic esophagitis. Primary conditions of eligibility are being symptomatic with EoE; for women capable of bearing children, a negative pregnancy test is mandatory in addition to using highly effective contraceptives until the end of the trial; commitment to adhere to all procedures and visit schedule outlined by the research team; willingness to give informed consent."

Answered by AI

Is participation in this trial open to individuals 45 years and older?

"The parameters for patient inclusion in this clinical trial necessitate a minimum age of 18 and a maximum age of 75."

Answered by AI

Has the FDA granted EP-104IAR 20 mg regulatory approval?

"The safety of EP-104IAR 20 mg was rated at 1 due to the limited data available from Phase 1 trials, leaving efficacy and safety yet unconfirmed."

Answered by AI

How many medical settings are currently administering this experiment?

"Those interested in participating are able to choose from 4 different recruitment sites, which include Adelaide, Vancouver and Amsterdam among others. To minimize travel requirements if one is accepted into the trial, we recommend selecting the nearest site for enrollment."

Answered by AI

To what extent are individuals participating in this research?

"To begin this medical experiment, 24 volunteers that meet the predetermined inclusion criteria need to be recruited. The research is taking place in multiple locations such as Royal Adelaide Hospital of South Australia and G.I. Research Institute in Vancouver, British Columbia."

Answered by AI
~8 spots leftby Nov 2024