Evaluating EP-104IAR for treating eosinophilic esophagitis in adults

A Phase 1b/2 Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104GI in Adults With Eosinophilic Esophagitis (RESOLVE)

This study is testing a new treatment called EP-104IAR to see if it can help adults with eosinophilic esophagitis feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eupraxia Pharmaceuticals Inc. (Industry-sponsored)
• Locations: 23 sites (Sydney, New South Wales and 22 other locations)
• Trial ID: NCT05608681 on ClinicalTrials.gov

What this trial studies

This is an open-label, dose-escalation trial assessing the safety, tolerability, and pharmacokinetics of EP-104IAR in adults diagnosed with eosinophilic esophagitis (EoE). The study will enroll approximately 27 to 33 participants across multiple dose cohorts, with additional participants in selected tolerable dose regimens to identify the recommended phase 2 doses. Participants will undergo endoscopic and histologic evaluations to measure the local effects of the treatment on EoE disease activity over a period of 24-52 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults with symptomatic eosinophilic esophagitis who can adhere to study procedures.

Not a fit: Patients with other significant esophageal diseases or conditions that interfere with the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from eosinophilic esophagitis.

How similar studies have performed: While this approach is novel, similar studies targeting eosinophilic esophagitis have shown promise in exploring new treatments.

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.

Where this trial is running

Sydney, New South Wales and 22 other locations

• Campbelltown Private Hospital — Sydney, New South Wales, Australia (Recruiting)
• Mater Hospital Brisbane — Brisbane, Queensland, Australia (Recruiting)
• Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
• Coastal Digestive Health — Maroochydore, Queensland, Australia (Recruiting)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
• Eastern Health Box Hill — Box Hill, Victoria, Australia (Recruiting)
• Northern Hospital Epping — Epping, Victoria, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)
• University of Calgary — Calgary, Alberta, Canada (Recruiting)
• UoA - South Edmonton Gastroenterology Research Clinic — Edmonton, Alberta, Canada (Recruiting)
• G.I. Research Institute — Vancouver, British Columbia, Canada (Recruiting)
• McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
• Amsterdam UMC — Amsterdam, Netherlands (Active_not_recruiting)
• Erasmus University Medical Center — Holland, Netherlands (Recruiting)
• Aotearoa Clinical Trials — Papatoetoe, Auckland, New Zealand (Recruiting)
• Waikato Hospital — Hamilton, New Zealand (Recruiting)
• Capital Coast and Hutt — Lower Hutt, New Zealand (Recruiting)
• Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
• Norfolk and Norwich University Hospital — Norwich, Norfolk, United Kingdom (Recruiting)
• Cardiff and Vale University Health Board-Wales — Cardiff, United Kingdom (Recruiting)
• Royal Liverpool University Hospital — Liverpool, United Kingdom (Recruiting)
• St George's University of London — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Pranali Ravikumar, MS

Conditions Eosinophilic Esophagitis