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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05608681
Registration number
NCT05608681
Ethics application status
Date submitted
19/10/2022
Date registered
8/11/2022
Titles & IDs
Public title
A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).
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Scientific title
A Phase 1b/2a, Open Label Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104IAR in Adults With Eosinophilic Esophagitis (RESOLVE)
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Secondary ID [1]
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EP-104IAR-102 (RESOLVE)
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Universal Trial Number (UTN)
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Trial acronym
RESOLVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Inflammatory and Immune System
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0
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EP-104IAR
Experimental: EP-104IAR 4 mg - 4 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 8 mg - 8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 20 mg - 8 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 30 mg - 12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 48 mg - 12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 64 mg - 16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 72 mg - 12 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 96 mg - 16 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Experimental: EP-104IAR 120 mg - 20 submucosal injections of EP-104IAR administered during an EGD procedure at the Baseline/Dosing visit.
Treatment: Drugs: EP-104IAR
Long-acting fluticasone propionate for injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment emergent adverse events (TEAEs)
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Assessment method [1]
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TEAEs will be summarized by dose/cohort
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Timepoint [1]
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52 weeks
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Primary outcome [2]
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Severity of treatment emergent adverse events (TEAEs)
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Assessment method [2]
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TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).
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Timepoint [2]
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0
52 weeks
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Primary outcome [3]
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Change from baseline in morning serum cortisol levels
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Assessment method [3]
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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.
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Timepoint [3]
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52 weeks
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Primary outcome [4]
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Plasma concentrations of fluticasone propionate
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Assessment method [4]
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Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
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Timepoint [4]
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52 weeks
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Primary outcome [5]
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Change from baseline in clinical safety laboratory measurements
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Assessment method [5]
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Clinical safety laboratory measurements will be summarized by dose/cohort and over time and compared to pre-dose values.
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Timepoint [5]
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12 weeks
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Primary outcome [6]
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Change from baseline in vital signs and physical examination results
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Assessment method [6]
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Vital signs and physical examination results will be summarized by dose/cohort and over time and compared to pre-dose values.
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Timepoint [6]
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12 weeks
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Secondary outcome [1]
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Peak eosinophil count (PEC)
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Assessment method [1]
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Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
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Timepoint [1]
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4 weeks
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Secondary outcome [2]
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Peak eosinophil count (PEC)
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Assessment method [2]
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Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
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Timepoint [2]
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0
12 weeks
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Secondary outcome [3]
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0
Peak eosinophil count (PEC)
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Assessment method [3]
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Biopsy specimens will be used to evaluate peak eosinophil counts (PEC). A higher number of eosinophils indicates more severe histological disease.
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Timepoint [3]
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36 weeks
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Secondary outcome [4]
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Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [4]
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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.
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Timepoint [4]
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2 weeks
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Secondary outcome [5]
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Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [5]
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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.
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [6]
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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.
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Timepoint [6]
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8 weeks
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Secondary outcome [7]
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Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [7]
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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.
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Timepoint [7]
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12 weeks
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Secondary outcome [8]
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0
Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [8]
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0
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.
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Timepoint [8]
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24 weeks
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Secondary outcome [9]
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0
Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [9]
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0
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.
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Timepoint [9]
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36 weeks
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Secondary outcome [10]
0
0
Change from baseline in the Straumann Dysphagia Index (SDI) score
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Assessment method [10]
0
0
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.
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Timepoint [10]
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52 weeks
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Secondary outcome [11]
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Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [11]
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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.
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Timepoint [11]
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4 weeks
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Secondary outcome [12]
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Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [12]
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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.
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Timepoint [12]
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8 weeks
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Secondary outcome [13]
0
0
Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [13]
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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.
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Timepoint [13]
0
0
12 weeks
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Secondary outcome [14]
0
0
Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [14]
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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.
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Timepoint [14]
0
0
24 weeks
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Secondary outcome [15]
0
0
Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [15]
0
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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.
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Timepoint [15]
0
0
36 weeks
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Secondary outcome [16]
0
0
Change from baseline in dysphagia measured on an 11 point Likert scale
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Assessment method [16]
0
0
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.
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Timepoint [16]
0
0
52 weeks
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Secondary outcome [17]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [17]
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The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [17]
0
0
4 weeks
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Secondary outcome [18]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [18]
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The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [18]
0
0
8 weeks
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Secondary outcome [19]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [19]
0
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The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [19]
0
0
12 weeks
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Secondary outcome [20]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [20]
0
0
The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [20]
0
0
24 weeks
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Secondary outcome [21]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [21]
0
0
The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [21]
0
0
36 weeks
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Secondary outcome [22]
0
0
Change from baseline in odynophagia measured on an 11 point Likert scale
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Assessment method [22]
0
0
The participant will assess the severity of their pain during swallowing over the previous 7 days using an 11 point Likert scale where 0 = no pain and 10 = most severe pain during swallowing.
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Timepoint [22]
0
0
52 weeks
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Secondary outcome [23]
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Change from baseline in the EoE Endoscopic Reference Score (EREFS)
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Assessment method [23]
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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.
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Timepoint [23]
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4 weeks
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Secondary outcome [24]
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Change from baseline in the EoE Endoscopic Reference Score (EREFS)
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Assessment method [24]
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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.
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Timepoint [24]
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12 weeks
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Secondary outcome [25]
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Change from baseline in the EoE Endoscopic Reference Score (EREFS)
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Assessment method [25]
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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.
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Timepoint [25]
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36 weeks
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Secondary outcome [26]
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Change from baseline in EoE Histology Scoring System (EoEHSS) score
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Assessment method [26]
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The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
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Timepoint [26]
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4 weeks
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Secondary outcome [27]
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Change from baseline in EoE Histology Scoring System (EoEHSS) score
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Assessment method [27]
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The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
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Timepoint [27]
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12 weeks
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Secondary outcome [28]
0
0
Change from baseline in EoE Histology Scoring System (EoEHSS) score
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Assessment method [28]
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0
The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
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Timepoint [28]
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36 weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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;
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
57
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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0
Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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0
Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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0
- Brisbane
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Recruitment postcode(s) [2]
0
0
- Adelaide
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Recruitment outside Australia
Country [1]
0
0
Canada
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State/province [1]
0
0
British Columbia
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Country [2]
0
0
Canada
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State/province [2]
0
0
Quebec
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Country [3]
0
0
Netherlands
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State/province [3]
0
0
Amsterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eupraxia Pharmaceuticals Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05608681
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Amanda Malone, PhD
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Address
0
0
Eupraxia Pharmaceuticals
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Christine Dobek, MSc
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Address
0
0
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Country
0
0
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Phone
0
0
778-873-8939
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05608681