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Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part A: Dupilumab or Placebo

Part B: Dupilumab or Placebo

Part C: Dupilumab

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24

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.

Secondary Outcome Measures

Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24

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.

Percent Change From Baseline in DSQ Total Score at Week 24

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.

Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24

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.

Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24

Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24

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.

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24

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).

NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24

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.

Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24

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.

Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24

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.

Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24

Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24

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

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52

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.

Percent Change in DSQ Total Score at Week 52

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.

Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52

Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52

Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52

Absolute Change in EoEHSS Mean Stage Score at Week 52

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52

Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

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.

Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period

NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52

NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52

Concentration of Functional Dupilumab in Serum at Week 52

Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response

Number of treatment-emergent ADA responses to dupilumab reported.

Full Information

NCT ID

NCT03633617

First Posted

August 14, 2018

Last Updated

June 2, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03633617

Brief Title

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 24, 2018 (Actual)

Primary Completion Date

September 9, 2021 (Actual)

Study Completion Date

June 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

321 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: Dupilumab or Placebo

Arm Type

Experimental

Arm Description

Arm Title

Part B: Dupilumab or Placebo

Arm Type

Experimental

Arm Description

Arm Title

Part C: Dupilumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

DUPIXENT, REGN668, SAR231893

Intervention Description

Solution for injection administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

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

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 24

Title

Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24

Description

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.

Time Frame

Baseline and week 24

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24

Description

Time Frame

Baseline and week 24

Title

Percent Change From Baseline in DSQ Total Score at Week 24

Description

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.

Time Frame

Baseline and week 24

Title

Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24

Description

Time Frame

Baseline and week 24

Title

Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24

Description

Time Frame

Baseline and week 24

Title

Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24

Description

Time Frame

Baseline and week 24

Title

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 24

Title

Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24

Description

Time Frame

Baseline and week 24

Title

NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24

Description

Time Frame

Baseline and week 24

Title

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 24

Title

Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24

Description

Time Frame

Baseline and week 24

Title

Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24

Description

Time Frame

Baseline and week 24

Title

Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24

Description

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.

Time Frame

Baseline and week 24

Title

Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24

Time Frame

At week 24

Title

Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24

Time Frame

At week 24

Title

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

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 52

Title

Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52

Description

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.

Time Frame

Baseline (of previous study part) and week 52

Title

Percent Change in DSQ Total Score at Week 52

Description

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.

Time Frame

Baseline (of previous study part) and week 52

Title

Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Absolute Change in EoEHSS Mean Stage Score at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 52

Title

Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52

Description

Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

Time Frame

At week 52

Title

Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52

Description

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.

Time Frame

Baseline (of previous study part) and week 52

Title

Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period

Time Frame

Baseline (of Part C) to week 28

Title

NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52

Description

Time Frame

Baseline (of previous study part) and week 52

Title

Concentration of Functional Dupilumab in Serum at Week 52

Time Frame

Baseline (of Part C) up to week 52

Title

Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response

Description

Number of treatment-emergent ADA responses to dupilumab reported.

Time Frame

Baseline (of previous study part) up to week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Study Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Regeneron Study Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Regeneron Study Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Regeneron Study Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Regeneron Study Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Regeneron Study Site

City

Mountain View

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Regeneron Study Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Regeneron Study Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Regeneron Study Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Regeneron Study Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Regeneron Study Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Regeneron Study Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Regeneron Study Site

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80124

Country

United States

Facility Name

Regeneron Study Site

City

Bristol

State/Province

Connecticut

ZIP/Postal Code

06010

Country

United States

Facility Name

Regeneron Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Regeneron Study Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Regeneron Study Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Regeneron Study Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Regeneron Study Site #1

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Regeneron Study Site #2

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Regeneron Study Site

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Regeneron Study Site

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

Regeneron Study Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Regeneron Study Site

City

Clive

State/Province

Iowa

ZIP/Postal Code

50325

Country

United States

Facility Name

Regeneron Study Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Regeneron Study Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Regeneron Study Site

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Regeneron Study Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Regeneron Study Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Regeneron Study Site

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Regeneron Study Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55446

Country

United States

Facility Name

Regeneron Study Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Regeneron Study Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68505

Country

United States

Facility Name

Regeneron Study Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Regeneron Study Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Regeneron Study Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Regeneron Study Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11023

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Regeneron Study Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Regeneron Study Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Regeneron Study Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Regeneron Study Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45415

Country

United States

Facility Name

Regeneron Study Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Regeneron Study Site

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Regeneron Study Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Regeneron Study Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Regeneron Study Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Regeneron Study Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Regeneron Study Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Facility Name

Regeneron Study Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

Regeneron Study Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75207

Country

United States

Facility Name

Regeneron Study Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Regeneron Study Site

City

Garland

State/Province

Texas

ZIP/Postal Code

75044

Country

United States

Facility Name

Regeneron Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Regeneron Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Regeneron Study Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Regeneron Study Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Regeneron Study Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24013

Country

United States

Facility Name

Regeneron Study Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98115

Country

United States

Facility Name

Regeneron Study Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Regeneron Study Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Regeneron Study Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Regeneron Study Site

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Regeneron Study Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Regeneron Study Site

City

Bruges

ZIP/Postal Code

8310

Country

Belgium

Facility Name

Regeneron Study Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Regeneron Study Site

City

Leuven

ZIP/Postal Code

03000

Country

Belgium

Facility Name

Regeneron Study Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A5W9

Country

Canada

Facility Name

Regeneron Study Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G6S6

Country

Canada

Facility Name

Regeneron Study Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T1C5

Country

Canada

Facility Name

Regeneron Study Site

City

Hamilton

ZIP/Postal Code

L8S 1G5

Country

Canada

Facility Name

Regeneron Study Site

City

Pessac

ZIP/Postal Code

33604 Cedex

Country

France

Facility Name

Regeneron Study Site

City

Toulouse

ZIP/Postal Code

TSA 50032-31059

Country

France

Facility Name

Regeneron Study Site

City

Hannover

ZIP/Postal Code

30459

Country

Germany

Facility Name

Regeneron Study Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Regeneron Study Site

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Regeneron Study Site

City

Genoa

ZIP/Postal Code

16132

Country

Italy

Facility Name

Regeneron Study Site

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Regeneron Study Site

City

Naples

ZIP/Postal Code

80100

Country

Italy

Facility Name

Regeneron Study Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Regeneron Study Site

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Regeneron Study Site

City

Rome

ZIP/Postal Code

00165

Country

Italy

Facility Name

Regeneron Study Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Regeneron Study Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Regeneron Study Site

City

Maastricht

ZIP/Postal Code

6229HX

Country

Netherlands

Facility Name

Regeneron Study Site

City

Nijmegen

ZIP/Postal Code

6525GA

Country

Netherlands

Facility Name

Regeneron Study Site

City

Tomelloso

State/Province

Ciudad Real

ZIP/Postal Code

13700

Country

Spain

Facility Name

Regeneron Study Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Regeneron Study Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Regeneron Study Site

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Regeneron Study Site

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

Facility Name

Regeneron Study Site

City

London

State/Province

Whitechapel

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Regeneron Study Site

City

Barnsley

State/Province

Yorkshire

ZIP/Postal Code

S752EP

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

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Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial