Status:
RECRUITING
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).
Lead Sponsor:
Eupraxia Pharmaceuticals Inc.
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 under...
Eligibility Criteria
Inclusion 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 (randomized 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 criteria 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 weeks prior to Screening, or the need for dilation prior to EGD at Baseline;
- 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 / cosyntropin (used in the ACTH stimulation test);
- 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 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.
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT05608681
Start Date
March 31 2023
End Date
December 1 2026
Last Update
March 19 2026
Active Locations (23)
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1
Campbelltown Private Hospital
Sydney, New South Wales, Australia
2
Mater Hospital Brisbane
Brisbane, Queensland, Australia
3
Princess Alexandra Hospital
Brisbane, Queensland, Australia
4
Coastal Digestive Health
Maroochydore, Queensland, Australia