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New treatment option for Eosinophilic Esophagitis
Official title A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
ClinicalTrials.gov ID: NCT05608681
What this study is testing
What is EP-104GI?
EP-104GI is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for eosinophilic esophagitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 (assigned by chance dose optimization portion):
- Has completed the assigned by chance dose optimization portion of the trial to Week 24, inclusive
You likely can't join if
- 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...
See the full eligibility 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 (assigned by chance dose optimization portion):
- Has completed the assigned by chance dose optimization portion of the trial to Week 24, inclusive
- Without safety concerns for receiving EP 104GI ie, does not meet
- 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...
- 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 /...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Maroochydore, Queensland, Australia
- Adelaide, South Australia, Australia
- Box Hill, Victoria, Australia
- Epping, Victoria, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
- Amsterdam, Netherlands
- Holland, Netherlands
- Papatoetoe, Auckland, New Zealand
- Hamilton, New Zealand
- Lower Hutt, New Zealand
- Zurich, Switzerland
- Norwich, Norfolk, United Kingdom
- Cardiff, United Kingdom
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Maroochydore, Queensland, Australia; Adelaide, South Australia, Australia; Box Hill, Victoria, Australia; Epping, Victoria, Australia and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.