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EP-104IAR for EoE (RESOLVE Trial)
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.
RESOLVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESOLVE Trial Design
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Who is running the clinical trial?
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- I have previously participated in this study and received treatment.I have an infection in my mouth or throat.I have symptoms of EoE.I have mouth or teeth problems that stop me from eating normally.I do not have any stomach or esophagus problems that could affect the study.I have no cancer history in the last 5 years, except for certain skin cancers or cervical pre-cancer.I am not using, and willing to avoid, certain medications during the study.I cannot take corticosteroids, but my diabetes is well-controlled without insulin.I do not have severe esophageal motility disorders except for EoE.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I do not have any active infections or recent use of antibiotics.I cannot safely undergo an EGD or biopsy due to high risks or esophagus issues.
- Group 1: EP-104IAR 4 mg
- Group 2: EP-104IAR 8 mg
- Group 3: EP-104IAR 12 mg
- Group 4: EP-104IAR 16 mg
- Group 5: EP-104IAR 10 mg
- Group 6: EP-104IAR 20 mg
- Group 7: EP-104IAR 30 mg
- Group 8: EP-104IAR 40 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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."
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