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):

  1. Has completed the randomized dose optimization portion of the trial to Week 24, inclusive
  2. 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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (23 locations)

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