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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03633617
Registration number
NCT03633617
Ethics application status
Date submitted
14/08/2018
Date registered
16/08/2018
Date last updated
28/06/2023
Titles & IDs
Public title
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
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Scientific title
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
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Secondary ID [1]
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2018-000844-25
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Secondary ID [2]
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R668-EE-1774
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Universal Trial Number (UTN)
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Trial acronym
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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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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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Other inflammatory or immune system disorders
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Inflammatory and Immune System
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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 - Dupilumab
Treatment: Drugs - Placebo
Experimental: Part A: Dupilumab or Placebo - Part A consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Experimental: Part B: Dupilumab or Placebo - Part B consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab dosing regimen 1, dupilumab dosing regimen 2 or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Experimental: Part C: Dupilumab - Part C is a 28-week extended active treatment period. Participants will receive dupilumab dosing regimen 1, dupilumab dosing regimen 2. At the end of the treatment period (week 52), participants will enter a 12-week follow-up period.
Treatment: Drugs: Dupilumab
Solution for injection administered subcutaneously
Treatment: Drugs: Placebo
Matching placebo
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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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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of =6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24
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Assessment method [1]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [1]
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At week 24
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Primary outcome [2]
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Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24
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Assessment method [2]
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The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
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Timepoint [2]
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Baseline and week 24
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Secondary outcome [1]
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Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24
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Assessment method [1]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
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Timepoint [1]
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Baseline and week 24
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Secondary outcome [2]
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Percent Change From Baseline in DSQ Total Score at Week 24
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Assessment method [2]
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The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
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Timepoint [2]
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Baseline and week 24
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Secondary outcome [3]
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Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24
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Assessment method [3]
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Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
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Timepoint [3]
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Baseline and week 24
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Secondary outcome [4]
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Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24
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Assessment method [4]
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Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
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Timepoint [4]
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Baseline and week 24
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Secondary outcome [5]
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Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24
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Assessment method [5]
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EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
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Timepoint [5]
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Baseline and week 24
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Secondary outcome [6]
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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24
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Assessment method [6]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [6]
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At week 24
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Secondary outcome [7]
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Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24
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Assessment method [7]
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NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
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Timepoint [7]
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Baseline and week 24
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Secondary outcome [8]
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NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24
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Assessment method [8]
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NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
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Timepoint [8]
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Baseline and week 24
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Secondary outcome [9]
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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of =1 Eos/Hpf in All Three Regions at Week 24
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Assessment method [9]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [9]
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At week 24
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Secondary outcome [10]
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Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24
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Assessment method [10]
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The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
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Timepoint [10]
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Baseline and week 24
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Secondary outcome [11]
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Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24
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Assessment method [11]
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The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
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Timepoint [11]
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Baseline and week 24
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Secondary outcome [12]
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Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24
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Assessment method [12]
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The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
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Timepoint [12]
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Baseline and week 24
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Secondary outcome [13]
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Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24
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Assessment method [13]
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Timepoint [13]
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At week 24
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Secondary outcome [14]
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Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24
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Assessment method [14]
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Timepoint [14]
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At week 24
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Secondary outcome [15]
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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of =6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 52
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Assessment method [15]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [15]
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At week 52
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Secondary outcome [16]
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Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52
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Assessment method [16]
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The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
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Timepoint [16]
0
0
Baseline (of previous study part) and week 52
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Secondary outcome [17]
0
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Percent Change in DSQ Total Score at Week 52
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Assessment method [17]
0
0
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
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Timepoint [17]
0
0
Baseline (of previous study part) and week 52
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Secondary outcome [18]
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Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52
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Assessment method [18]
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EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
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Timepoint [18]
0
0
Baseline (of previous study part) and week 52
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Secondary outcome [19]
0
0
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52
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Assessment method [19]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
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Timepoint [19]
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Baseline (of previous study part) and week 52
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Secondary outcome [20]
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Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52
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Assessment method [20]
0
0
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
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Timepoint [20]
0
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Baseline (of previous study part) and week 52
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Secondary outcome [21]
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Absolute Change in EoEHSS Mean Stage Score at Week 52
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Assessment method [21]
0
0
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
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Timepoint [21]
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Baseline (of previous study part) and week 52
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Secondary outcome [22]
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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52
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Assessment method [22]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [22]
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At week 52
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Secondary outcome [23]
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Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of =1 Eos/Hpf in All Three Regions at Week 52
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Assessment method [23]
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Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
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Timepoint [23]
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At week 52
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Secondary outcome [24]
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Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52
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Assessment method [24]
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0
The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
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Timepoint [24]
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Baseline (of previous study part) and week 52
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Secondary outcome [25]
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Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
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Assessment method [25]
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The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
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Timepoint [25]
0
0
Baseline (of previous study part) and week 52
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Secondary outcome [26]
0
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Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
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Assessment method [26]
0
0
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
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Timepoint [26]
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0
Baseline (of previous study part) and week 52
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Secondary outcome [27]
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Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period
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Assessment method [27]
0
0
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Timepoint [27]
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Baseline (of Part C) to week 28
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Secondary outcome [28]
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NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52
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Assessment method [28]
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NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
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Timepoint [28]
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0
Baseline (of previous study part) and week 52
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Secondary outcome [29]
0
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NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52
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Assessment method [29]
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NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
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Timepoint [29]
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Baseline (of previous study part) and week 52
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Secondary outcome [30]
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Concentration of Functional Dupilumab in Serum at Week 52
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Assessment method [30]
0
0
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Timepoint [30]
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Baseline (of Part C) up to week 52
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Secondary outcome [31]
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Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response
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Assessment method [31]
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Number of treatment-emergent ADA responses to dupilumab reported.
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Timepoint [31]
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Baseline (of previous study part) up to week 52
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Eligibility
Key inclusion criteria
Key Inclusion Criteria (Parts A & B):
- A documented diagnosis of EoE by endoscopic biopsy
- Baseline endoscopic biopsies with a demonstration on central reading of
intraepithelial eosinophilic infiltration
- History (by patient report) of an average of at least 2 episodes of dysphagia (with
intake of solids) per week in the 4 weeks prior to screening
Key
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Minimum age
12
Years
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Maximum age
No limit
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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
Exclusion Criteria (Parts A & B):
- Body weight =40 kg
- Prior participation in a dupilumab clinical trial, or past or current treatment with
dupilumab
- Initiation or change of a food-elimination diet regimen or re-introduction of a
previously eliminated food group in the 6 weeks prior to screening.
- Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic
syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
- Active Helicobacter pylori infection
- History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior
esophageal surgery
- Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm
upper endoscope or any critical esophageal stricture that requires dilation at
screening
- History of bleeding disorders or esophageal varices
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study
Key Exclusion Criteria (Part C):
- Participants who, during Part A or Part B, developed a serious adverse event (SAE)
and/or adverse event (AE) deemed related to study drug, which in the opinion of the
investigator could indicate that continued treatment with study drug may present an
unreasonable risk for the participant
- Participants who became pregnant during Part A or Part B
- Participants who are prematurely discontinued from study drug due to an AE (patients
who are prematurely discontinued from study drug due to lack of efficacy are eligible
to enter Part C)
- Patients who did not undergo endoscopy with biopsies prior to receiving rescue
treatment
Note: Other inclusion/ exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
24/09/2018
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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
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Actual
7/06/2022
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Sample size
Target
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Accrual to date
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Final
321
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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0
Regeneron Study Site - Camperdown
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Recruitment hospital [2]
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Regeneron Study Site - Woolloongabba
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Recruitment hospital [3]
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Regeneron Study Site - Elizabeth Vale
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Recruitment hospital [4]
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Regeneron Study Site - Melbourne
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Recruitment postcode(s) [1]
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0
2050 - Camperdown
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Idaho
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Indiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Iowa
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kansas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Maryland
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Michigan
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Minnesota
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Nebraska
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Country [17]
0
0
United States of America
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State/province [17]
0
0
New York
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Country [18]
0
0
United States of America
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State/province [18]
0
0
North Carolina
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Ohio
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Pennsylvania
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Country [21]
0
0
United States of America
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State/province [21]
0
0
South Carolina
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Tennessee
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Sanofi
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Summary
Brief summary
The primary objectives of the study by study part are:
Part A:
To determine the treatment effect of dupilumab compared with placebo in adult and adolescent
patients with EoE after 24 weeks of treatment as assessed by histological and clinical
measures and to inform/confirm the final sample size determination for Part B.
Part B:
To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and
adolescent patients with EoE after 24 weeks of treatment as assessed by histological and
clinical measures.
Part C:
To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients
with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.
The secondary objectives of the study are:
- To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up
to 52 weeks in adult and adolescent patients with EoE
- To explore the relationship between dupilumab concentration and responses in adult and
adolescent patients with EoE, using descriptive analyses
- To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE
and type 2 inflammation
- To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks
and 52 weeks of treatment in adult and adolescent patients with EoE who have previously
received swallowed topical corticosteroids
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03633617
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Contacts
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Regeneron Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03633617
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