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Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)

Primary Purpose

Eosinophilic Esophagitis (EoE)

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dupilumab

Matching Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis (EoE)

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

A documented diagnosis of eosinophilic esophagitis (EoE)
Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration

Key Exclusion Criteria:

Body weight <5 kg or ≥60 kg at screening
Other causes of esophageal eosinophilia
Active Helicobacter pylori
History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure
Active parasitic infection or suspected parasitic infection
Known or suspected immunodeficiency disorder

Key Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in protocol):

Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country
Patients who, during their previous participation in this clinical trial, developed an SAE and/or AE deemed related to dupilumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient
Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or prior to receiving rescue treatment Note: If the endoscopy with biopsies could not occur due to COVID-19 restrictions and rescue treatment was needed to be initiated without delay, these patients will be eligible to participate in Part C
Patients who became pregnant during their previous participation in this dupilumab clinical trial
Patients who, during their previous participation in this trial, were prematurely withdrawn because of a protocol violation, poor compliance, or inability to complete required study assessments

NOTE: Other protocol defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Part A - High Dose

Part A - Low Dose

Part B - High Dose

Part B - Low Dose

Part C - High Dose

Arm Description

Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight

Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight

Part C consists of up to 108-week open-label extension period. All patients will receive higher exposure dupilumab subcutaneous (SC) administration at tiered dosing regimens based on body weight. No matching placebo administered in Part C.

Outcomes

Primary Outcome Measures

Proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6 eos/hpf (400×)

Secondary Outcome Measures

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Part A

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Part B

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Part C

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Part C

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Part A

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Part B

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Part C

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Part C

Absolute change in mean eosinophilic esophagitis (EoE) Histology Scoring System (EoE-HSS)

Part A The EoEHSS assesses the severity (grade) and extent (stage) of abnormalities using a 4-point scale (0 normal; 3 maximum change).

Absolute change in mean EoE-HSS

Part B The EoEHSS as stated above.

Absolute change in mean EoE-HSS

Part C The EoEHSS as stated above.

Absolute change in mean EoE-HSS

Part C The EoEHSS as stated above.

Absolute change in Eosinophilic Esophagitis-Endoscopic Reference (EoE EREFS)

Part A EoE esophageal characteristics will be analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease using both overall scores and scores for each individual characteristic. The proximal and distal esophageal regions will be scored separately; The score for each region ranges from 0 to 9 and the overall score ranges from 0 to 18.

Absolute change in EoE-EREFS

Part B EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Absolute change in EoE-EREFS

Part C EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Absolute change in EoE-EREFS

Part C EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Change in the type 2 inflammation transcriptional signature

Part A

Change in the type 2 inflammation transcriptional signature

Part B

Change in the proportion of days with 1 or more EoE signs as measured by the Pediatric EoE Sign/Symptom Questionnaire- Caregiver version (PESQ-C)

Part A: For patients aged ≥1 to <12 years The PESQ-C is an observer-reported outcome measure intended to be completed independently by caregivers. The PESQ-C will measure occurrence of signs of EoE and will be completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding the week 16 visit will be used to calculate the proportion of days or total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE signs.

Change in the proportion of days with 1 or more EoE signs as measured by the PESQ-C

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Number of sign-free days during the 14-day period preceding week 16 as measured by the PESQ-C

Part A: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Number of sign-free days during the 14-day period preceding week 52 as measured by the PESQ-C

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Change in the proportion of total segments within a day with 1 or more EoE signs as measured by the PESQ-C

Part A: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Change in the proportion of total segments within a day with 1 or more EoE signs as measured by the PESQ-C

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Change in the proportion of days with 1 or more EoE symptoms as measured by the Pediatric EoE Sign/Symptom Questionnaire- Patient version (PESQ-P)

Part A: For patients aged ≥8 to <12 years The PESQ-P is a patient-reported outcome measure intended to be completed independently by EoE patients. The PESQ-P will measure occurrence and severity of EoE symptoms and will be completed once daily via an electronic diary. Data from a 14-day period preceding the baseline visit and a 14-day period preceding the week 16 visit will be used to calculate the proportion of days or total time segments within a day (night, morning, afternoon, evening) with 1 or more EoE symptoms.

Change in the proportion of days with 1 or more EoE symptoms as measured by the PESQ-P

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Number of symptom-free days during the 14-day period preceding week 16 as measured by the PESQ-P

Part A: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Number of symptom-free days during the 14-day period preceding week 52 as measured by the PESQ-P

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by the PESQ-P

Part A: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by the PESQ-P

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Change in total score as measured by the PEESSv2.0-caregiver version questionnaire

Part A: For patients aged ≥1 to <12 years The PEESSv2.0-caregiver version assesses the frequency and severity of EoE symptoms among pediatric patients (Franciosi, 2011). The PEESSv2.0 consists of 20 items and has a one-month recall period. The total score ranges from 0 to 100; higher scores indicate greater symptom burden of among pediatric EoE patients

Change in total score as measured by the PEESSv2.0- caregiver version questionnaire

Part C The PEESSv2.0-caregiver version as stated above.

Normalized Enrichment Scores (NES) for the relative change in the EoE diagnostic panel (EDP) transcriptome signature

Part A NES reflects the degree to which the activity level of a set of 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 (Barbie, 2009)(Subramanian, 2005). NES scores will be calculated for each transcriptome signature for each sample for statistical analyses.

NES for the relative change in the EDP transcriptome signature

Part B NES as stated above.

NES for the relative change in the EDP transcriptome signature

Part C NES as stated above.

NES for the relative change in the EDP transcriptome signature

Part C NES as stated above.

NES for the relative change in the type 2 inflammation transcriptome signature

Part A NES as stated above.

NES for the relative change in the type 2 inflammation transcriptome signature

Part B NES as stated above.

NES for the relative change in the type 2 inflammation transcriptome signature

Part C NES as stated above.

Change in body weight for age percentile

Part B

Change in body weight for age percentile

Part C

Change in body mass index for age z-score

Part B: For patients ≥2 years of age

Change in body mass index for age z-score

Part C: For patients ≥2 years of age

Change in weight for age z-score

Part B

Change in weight for age z-score

Part C

Change in weight for height z-score

Part B

Change in weight for height z-score

Part C

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf (400×)

Part C

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf (400×)

Part C

Proportion of patients (with food elimination diet regimens at baseline) that have a re-introduction of a previously eliminated food group

Part C

Proportion of patients (with food elimination diet regimens at baseline) that have a re-introduction of a previously eliminated food group

Part C

Incidence of treatment-emergent adverse events (TEAEs)

Part A

Incidence of TEAEs

Part B

Incidence of TEAEs

Part C

Incidence of treatment-emergent serious adverse events (SAEs)

Part A

Incidence of treatment-emergent SAEs

Part B

Incidence of treatment-emergent SAEs

Part C

Incidence of treatment-emergent adverse events of special interest (AESIs)

Part A

Incidence of treatment-emergent AESIs

Part B

Incidence of treatment-emergent AESIs

Part C

Incidence of TEAEs leading to permanent discontinuation of study treatment

Part A

Incidence of TEAEs leading to permanent discontinuation of study treatment

Part B

Incidence of TEAEs leading to permanent discontinuation of study treatment

Part C

Incidence of treatment-emergent Anti-drug antibody (ADA) responses and titer

Part A

Incidence of treatment-emergent ADA responses and titer

Part B

Incidence of treatment-emergent ADA responses and titer

Part C

Concentration of functional dupilumab in serum

Full Information

NCT ID

NCT04394351

First Posted

May 7, 2020

Last Updated

June 1, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04394351

Brief Title

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

Acronym

EoE KIDS

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

June 2, 2022 (Actual)

Study Completion Date

July 7, 2025 (Anticipated)

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 objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation To study the effects of dupilumab on the type 2 inflammation gene expression signature To evaluate the concentration-time profile of functional dupilumab in serum in this population To assess efficacy of long-term (up to 160 weeks) dupilumab treatment To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment To evaluate the impact of dupilumab treatment on EoE signs and symptoms

Detailed Description

This is a 3-part study: Part A: Double-blind 16-week treatment period Part B: 36-week extended active treatment period Part C: Up to108 weeks open-label extension period

6. Conditions and Keywords

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

Eosinophilic Esophagitis (EoE)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A - High Dose

Arm Type

Experimental

Arm Description

Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight

Arm Title

Part A - Low Dose

Arm Type

Experimental

Arm Description

Part A consists of a 16-week double-blind treatment period. Patients will be randomized to receive dupilumab or placebo subcutaneous (SC) administration at tiered dosing regimens based on body weight

Arm Title

Part B - High Dose

Arm Type

Experimental

Arm Description

Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight

Arm Title

Part B - Low Dose

Arm Type

Experimental

Arm Description

Part B consists of a 36-week extended active treatment period. All patients to receive subcutaneous (SC) administration at tiered dosing regimens based on body weight

Arm Title

Part C - High Dose

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Other Intervention Name(s)

•DUPIXENT, •REGN668, •SAR231893

Intervention Description

Single-use, prefilled syringe

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

Matching formulation and regimen (depending on the weight tier) as dupilumab without the active substance

Primary Outcome Measure Information:

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count ≤6 eos/hpf (400×)

Time Frame

At Week 16

Secondary Outcome Measure Information:

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Description

Part A

Time Frame

At Week 16

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Description

Part B

Time Frame

At Week 52

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Description

Part C

Time Frame

At Week 100

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf

Description

Part C

Time Frame

At Week 160

Title

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Description

Part A

Time Frame

Baseline to Week 16

Title

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Description

Part B

Time Frame

Baseline to Week 52

Title

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Description

Part C

Time Frame

Baseline to Week 100

Title

Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)

Description

Part C

Time Frame

Baseline to Week 160

Title

Absolute change in mean eosinophilic esophagitis (EoE) Histology Scoring System (EoE-HSS)

Description

Part A The EoEHSS assesses the severity (grade) and extent (stage) of abnormalities using a 4-point scale (0 normal; 3 maximum change).

Time Frame

Baseline to Week 16

Title

Absolute change in mean EoE-HSS

Description

Part B The EoEHSS as stated above.

Time Frame

Baseline to Week 52

Title

Absolute change in mean EoE-HSS

Description

Part C The EoEHSS as stated above.

Time Frame

Baseline to Week 100

Title

Absolute change in mean EoE-HSS

Description

Part C The EoEHSS as stated above.

Time Frame

Baseline to Week 160

Title

Absolute change in Eosinophilic Esophagitis-Endoscopic Reference (EoE EREFS)

Description

Time Frame

Baseline to Week 16

Title

Absolute change in EoE-EREFS

Description

Part B EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Time Frame

Baseline to Week 52

Title

Absolute change in EoE-EREFS

Description

Part C EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Time Frame

Baseline to Week 100

Title

Absolute change in EoE-EREFS

Description

Part C EoE esophageal characteristics will be analyzed based on the EoE-EREFS, as stated above.

Time Frame

Baseline to Week 160

Title

Change in the type 2 inflammation transcriptional signature

Description

Part A

Time Frame

Baseline at Week 16

Title

Change in the type 2 inflammation transcriptional signature

Description

Part B

Time Frame

Baseline at Week 52

Title

Change in the proportion of days with 1 or more EoE signs as measured by the Pediatric EoE Sign/Symptom Questionnaire- Caregiver version (PESQ-C)

Description

Time Frame

Baseline to Week 16

Title

Change in the proportion of days with 1 or more EoE signs as measured by the PESQ-C

Description

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Time Frame

Baseline to Week 52

Title

Number of sign-free days during the 14-day period preceding week 16 as measured by the PESQ-C

Description

Part A: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Time Frame

Up to Week 16

Title

Number of sign-free days during the 14-day period preceding week 52 as measured by the PESQ-C

Description

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Time Frame

Up to Week 52

Title

Change in the proportion of total segments within a day with 1 or more EoE signs as measured by the PESQ-C

Description

Part A: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Time Frame

Baseline to Week 16

Title

Change in the proportion of total segments within a day with 1 or more EoE signs as measured by the PESQ-C

Description

Part B: For patients aged ≥1 to <12 years The PESQ-C as stated above.

Time Frame

Baseline to Week 52

Title

Change in the proportion of days with 1 or more EoE symptoms as measured by the Pediatric EoE Sign/Symptom Questionnaire- Patient version (PESQ-P)

Description

Time Frame

Baseline to Week 16

Title

Change in the proportion of days with 1 or more EoE symptoms as measured by the PESQ-P

Description

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Time Frame

Baseline to Week 52

Title

Number of symptom-free days during the 14-day period preceding week 16 as measured by the PESQ-P

Description

Part A: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Time Frame

Up to Week 16

Title

Number of symptom-free days during the 14-day period preceding week 52 as measured by the PESQ-P

Description

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Time Frame

Up to Week 52

Title

Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by the PESQ-P

Description

Part A: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Time Frame

Baseline to Week 16

Title

Change in the proportion of total segments within a day with 1 or more EoE symptoms as measured by the PESQ-P

Description

Part B: For patients aged ≥8 to <12 years The PESQ-P as stated above.

Time Frame

Baseline to Week 52

Title

Change in total score as measured by the PEESSv2.0-caregiver version questionnaire

Description

Time Frame

Baseline to Week 16

Title

Change in total score as measured by the PEESSv2.0- caregiver version questionnaire

Description

Part C The PEESSv2.0-caregiver version as stated above.

Time Frame

Baseline to Week 160

Title

Normalized Enrichment Scores (NES) for the relative change in the EoE diagnostic panel (EDP) transcriptome signature

Description

Time Frame

Baseline to Week 16

Title

NES for the relative change in the EDP transcriptome signature

Description

Part B NES as stated above.

Time Frame

Baseline to Week 52

Title

NES for the relative change in the EDP transcriptome signature

Description

Part C NES as stated above.

Time Frame

Baseline to Week 100

Title

NES for the relative change in the EDP transcriptome signature

Description

Part C NES as stated above.

Time Frame

Baseline to Week 160

Title

NES for the relative change in the type 2 inflammation transcriptome signature

Description

Part A NES as stated above.

Time Frame

Baseline to Week 16

Title

NES for the relative change in the type 2 inflammation transcriptome signature

Description

Part B NES as stated above.

Time Frame

Baseline to Week 52

Title

NES for the relative change in the type 2 inflammation transcriptome signature

Description

Part C NES as stated above.

Time Frame

Baseline to Week 100

Title

Change in body weight for age percentile

Description

Part B

Time Frame

Baseline at Week 52

Title

Change in body weight for age percentile

Description

Part C

Time Frame

Baseline up to Week 160

Title

Change in body mass index for age z-score

Description

Part B: For patients ≥2 years of age

Time Frame

Baseline to Week 52

Title

Change in body mass index for age z-score

Description

Part C: For patients ≥2 years of age

Time Frame

Baseline to up to Week 160

Title

Change in weight for age z-score

Description

Part B

Time Frame

Baseline to Week 52

Title

Change in weight for age z-score

Description

Part C

Time Frame

Baseline up to Week 160

Title

Change in weight for height z-score

Description

Part B

Time Frame

Baseline to Week 52

Title

Change in weight for height z-score

Description

Part C

Time Frame

Baseline up to Week 160

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf (400×)

Description

Part C

Time Frame

At Week 100

Title

Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf (400×)

Description

Part C

Time Frame

At Week 160

Title

Proportion of patients (with food elimination diet regimens at baseline) that have a re-introduction of a previously eliminated food group

Description

Part C

Time Frame

Baseline by Week 100

Title

Proportion of patients (with food elimination diet regimens at baseline) that have a re-introduction of a previously eliminated food group

Description

Part C

Time Frame

Baseline by Week 160

Title

Incidence of treatment-emergent adverse events (TEAEs)

Description

Part A

Time Frame

Up to Week 16

Title

Incidence of TEAEs

Description

Part B

Time Frame

Up to Week 52

Title

Incidence of TEAEs

Description

Part C

Time Frame

Up to Week 160

Title

Incidence of treatment-emergent serious adverse events (SAEs)

Description

Part A

Time Frame

Up to Week 16

Title

Incidence of treatment-emergent SAEs

Description

Part B

Time Frame

Up to Week 52

Title

Incidence of treatment-emergent SAEs

Description

Part C

Time Frame

Up to Week 160

Title

Incidence of treatment-emergent adverse events of special interest (AESIs)

Description

Part A

Time Frame

Up to Week 16

Title

Incidence of treatment-emergent AESIs

Description

Part B

Time Frame

Up to Week 52

Title

Incidence of treatment-emergent AESIs

Description

Part C

Time Frame

Up to Week 160

Title

Incidence of TEAEs leading to permanent discontinuation of study treatment

Description

Part A

Time Frame

Up to Week 16

Title

Incidence of TEAEs leading to permanent discontinuation of study treatment

Description

Part B

Time Frame

Up to Week 52

Title

Incidence of TEAEs leading to permanent discontinuation of study treatment

Description

Part C

Time Frame

Up to Week 160

Title

Incidence of treatment-emergent Anti-drug antibody (ADA) responses and titer

Description

Part A

Time Frame

Up to Week 16

Title

Incidence of treatment-emergent ADA responses and titer

Description

Part B

Time Frame

Up to Week 52

Title

Incidence of treatment-emergent ADA responses and titer

Description

Part C

Time Frame

Up to Week 160

Title

Concentration of functional dupilumab in serum

Time Frame

Baseline to end of study, Up to Week 160

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: A documented diagnosis of eosinophilic esophagitis (EoE) Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration Key Exclusion Criteria: Body weight <5 kg or ≥60 kg at screening Other causes of esophageal eosinophilia Active Helicobacter pylori History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopy procedure Active parasitic infection or suspected parasitic infection Known or suspected immunodeficiency disorder Key Exclusion for Patients Re-Entering the Study (for Entry into Part C, as defined in protocol): Patients who are ≥12 years old, weigh ≥40 kg (or minimum weight for which dupilumab is approved for EoE), and dupilumab is commercially available for the treatment of EoE in their country Patients who, during their previous participation in this clinical trial, developed an SAE and/or AE deemed related to dupilumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient Patients who did not undergo endoscopy with biopsies at week 16 and/or week 52 or prior to receiving rescue treatment Note: If the endoscopy with biopsies could not occur due to COVID-19 restrictions and rescue treatment was needed to be initiated without delay, these patients will be eligible to participate in Part C Patients who became pregnant during their previous participation in this dupilumab clinical trial Patients who, during their previous participation in this trial, were prematurely withdrawn because of a protocol violation, poor compliance, or inability to complete required study assessments NOTE: Other protocol defined 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

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Regeneron Study Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Regeneron Study Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

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

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Regeneron Study Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Regeneron Study Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Regeneron Study Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

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

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

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

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Regeneron Study Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Regeneron Study Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

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

New York

State/Province

New York

ZIP/Postal Code

10065

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

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

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

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

Houston

State/Province

Texas

ZIP/Postal Code

77030

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

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All Individual Patient Data that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

IPD Sharing URL

https://vivli.org/

Learn more about this trial

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

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Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (EoE KIDS)

Eosinophilic Esophagitis (EoE)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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