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

ConditionEosinophilic Esophagitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEupraxia Pharmaceuticals Inc.

About this trial

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 understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. 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). In the Phase 2 randomized dose optimization portion of the study, approximately 120 subjects will be randomized to Dose A (120 mg total dose), Dose B (160 mg total dose), or matching vehicle control, with an overall assignment ratio of 1:1:1. The total number of participants in both portions of the study will be approximately 160. The study involves 8-10 site visits spread over approximately 52 weeks. Participants in an extended PK sub study will have up to 4 additional visits, to a maximum of 108 weeks post-dose. The participants will either receive the active study drug (EP-104GI) or matching vehicle control. Matching vehicle control will be used only in randomized dose optimization portion of the study. Participants randomized to receive vehicle control may receive EP-104GI (Dose A or Dose B) following the completion of Week 24 providing they meet eligibility criteria for crossover to EP-104GI. Participants randomized to receive EP-104GI on Day 0 will not receive EP-104GI or vehicle control at Week 24. The study drug or matching vehicle control 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-104GI. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-5 EGDs with esophageal biopsies at the Baseline, Week 4 (dose escalation phase only), Week 12, Week 24 (randomized dose optimization phase only), Week 26, and Week 52 (randomized dose optimization phase only).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • EP-104GI

    Drug

    Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle

  • Matching vehicle control

    Other intervention

    A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.

Treatment groups

117 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: EP-104GI 4 mgExperimental treatment 1 intervention
Group B: EP-104GI 8 mgExperimental treatment 1 intervention
Group C: EP-104GI 20 mgExperimental treatment 1 intervention
Group D: EP-104GI 30 mgExperimental treatment 1 intervention
Group E: EP-104GI 48 mgExperimental treatment 1 intervention
Group F: EP-104GI 64 mgExperimental treatment 1 intervention
Group G: EP-104GI 80 mgExperimental treatment 1 intervention
Group H: EP-104GI 96 mgExperimental treatment 1 intervention
Group I: EP-104GI 120 mgExperimental treatment 1 intervention
Group J: EP-104GI Dose A or matching vehicle controlPlacebo comparator 2 interventions
Group K: EP-104GI 160 mgExperimental treatment 1 intervention
Group L: EP-104GI Dose B or matching vehicle controlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)

TEAEs will be summarized by dose/cohort

Time frame
52 weeks
2

Dose Escalation- Severity of treatment emergent adverse events (TEAEs)

TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).

Time frame
52 weeks
3

Dose Escalation- Change from baseline in morning serum cortisol levels

Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency.

Time frame
52 weeks
4

Dose Escalation- Plasma concentrations of fluticasone propionate

Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.

Time frame
108 weeks

Secondary outcomes

1

Dose Escalation- Peak eosinophil count (PEC)

Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.

Time frame
36 weeks
2

Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score

The SDI is a patient-reported outcome measure of dysphagia with a 7-day recall period. The SDI assesses the frequency and intensity of dysphagia on two separate 5-point and 6-point scales. Total SDI scores are calculated by adding the two sub-scores (range, 0-9), with a higher total score indicating more severe dysphagia.

Time frame
52 weeks
3

Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale

The participant will assess the severity of their dysphagia symptoms (troubles to swallow) over the previous 7-days using an 11-point Likert scale where 0 = no trouble and 10 = most severe trouble swallowing.

Time frame
52 weeks
4

Dose Escalation- Change from baseline in the EoE Endoscopic Reference Score (EREFS)

Endoscopic Reference Score (EREFS) scoring system is used to determine the severity of 5 endoscopic findings: edema, rings, exudates, furrows, and strictures. The total EREFS is calculated by summing the grades of the 5 individual endoscopic items (range, 0 to 9), with higher scores indicating more severe endoscopic disease.

Time frame
36 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eupraxia Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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