RESOLVE EoE study
Summary
This study is evaluating an investigational treatment for Eosinophilic Esophagitis (EoE) called EP-104GI, which may help reduce inflammation and improve symptoms.
EP-104GI is a long-acting injectable corticosteroids [fluticasone propionate] to be injected directly into the esophagus during an Endoscopy procedure.
Eligibility
Eligible ages: 18 to 75
Inclusion criteria:
1. Adults 18 to 75 years of age, inclusive
2. Symptomatic EoE with confirmed historical diagnosis of EoE
3. For women of childbearing potential, a negative pregnancy test (at baseline) and willing to use a highly effective method of birth control for the entire duration of the study
4. Willing and able to adhere to study-related procedures and visit schedule
5. Willing and able to provide informed consent
Exclusion criteria:
• You have other known conditions affecting your esophagus or digestive system, such as:
o Barrett’s esophagus
o Celiac disease
o Inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis)
o Past surgery on your esophagus
Note: Occasional acid reflux (heartburn) is okay.
• You currently have an infection in your mouth or esophagus (for example, a fungal, viral, or bacterial infection).
• You have problems with your mouth, throat, or teeth that make it difficult to eat normally (other than EoE).
• You have been told you have a serious problem with how your esophagus moves (other than EoE).
• You have had your esophagus stretched (dilation) within the past 8 weeks, or have been told you may need this procedure soon.
• You have a condition where steroid medications are not safe for you (for example, certain hormone or endocrine disorders).
Note: Well-controlled type 2 diabetes is okay.
• You currently have an active infection (such as tuberculosis, hepatitis B or C, HIV, or another serious infection), or:
o Needed IV antibiotics in the past 4 weeks, or
o Took oral antibiotics in the past 2 weeks
• You are allergic to steroid medications or similar ingredients.
• You are pregnant, breastfeeding, or planning to become pregnant within the next year.
• You have had cancer in the past 5 years (except for certain treated skin cancers or cervical pre-cancer).
• You have had issues with alcohol or drug abuse in the past 6 months.
• You are not willing or able to stop certain medications that are not allowed during the study (e.g. Pulmicort, Budesonide, Dupixent)
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
Eva Mak, Research Coordinator (eva.mak@ucalgary.ca)
Principal investigator:
Milli Gupta
Clinical trial:
Yes
REB-ID:
REB25-0942