A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).

Last updated: July 26, 2024
Sponsor: Eupraxia Pharmaceuticals Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Heartburn (Pediatric)

Esophageal Disorders

Heartburn

Treatment

EP-104IAR

Clinical Study ID

NCT05608681
EP-104IAR-102 (RESOLVE)
  • Ages 18-75
  • All Genders

Study Summary

An open-label, dose-escalation study to explore the safety, tolerability and pharmacokinetics of EP-104IAR in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104IAR on eosinophilic EoE disease activity.

Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort in approximately 9 cohorts. The number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded.

An additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (RP2D).

The study involves 8-10 site visits spread over approximately 24-52 weeks.

All participants will receive active study drug (EP-104IAR), The study drug will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit.

Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104IAR.

Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-4 EGDs with esophageal biopsies at the Baseline/Dosing Visit, at 4, 12 and 36 weeks post dose.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic EoE;

  • For women of childbearing potential, a negative pregnancy test and willing to use ahighly 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.

Exclusion

Exclusion Criteria:

  • Concomitant esophageal disease, relevant GI disease, or any condition, history, orlaboratory 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 EGDor biopsy, or narrowing of the esophagus that precludes EGD with a standard 9-10 mmendoscope, stricture requiring dilation within 8 weeks prior to Screening, or theneed for dilation prior to EGD at Baseline;

  • Any condition for which the use of corticosteroids is contraindicated (Participantswith well controlled non-insulin dependent diabetes are permitted);

  • Active or quiescent systemic fungal, bacterial, viral, or parasitic infections, orocular herpes simplex. Or recent use of IV or oral antibiotics;

  • Hypersensitivity, or intolerance to corticosteroids, or to any of the ingredients inthe investigational medicinal product;

  • Recent use of disallowed medications, or unwillingness to not use disallowedmedications during the study;

  • Recent initiation of a elimination or elemental diet (dietary therapy must remainstable 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 thestudy;

  • Malignancies or history of malignancy within prior 5 years, except for treated orexcised 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 altersparticipant risk, confounds results, or prevents the participant from complying withstudy requirements.

Study Design

Total Participants: 57
Treatment Group(s): 1
Primary Treatment: EP-104IAR
Phase: 1/2
Study Start date:
March 31, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Princess Alexandra Hospital

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • G.I. Research Institute

    Vancouver, British Columbia V6Z 2K5
    Canada

    Active - Recruiting

  • McGill University Health Center

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam, 1105
    Netherlands

    Active - Recruiting

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