Evaluating EP-104IAR for treating eosinophilic esophagitis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Pranali Ravikumar, MS
• Email: pravikumar@eupraxiapharma.com
• Phone: 647-895-3016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a mucosal impedance device to help diagnose chronic esophageal problems

  This test tries a mucosal impedance device during upper endoscopy to see if it helps diagnose people with chronic reflux (GERD) or eosinophilic esophagitis.

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• Esophageal string test to screen for eosinophilic esophagitis in adults of African descent with swallowing problems

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• Improving management of eosinophilic esophagitis in children and adolescents

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• How common FIRE is and what it looks like in children with eosinophilic esophagitis

  This project will see how often and in what ways Food Induced Immediate Response of the Esophagus (FIRE) occurs in children aged 6–17 who have eosinophilic esophagitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.