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A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis (ENGAGE)

Primary Purpose

Eosinophilic Gastritis, Eosinophilic Duodenitis, Eosinophilic Gastrointestinal Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dupilumab Dose 1
Dupilumab Dose 2
Matching Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Gastritis focused on measuring Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID)

Eligibility Criteria

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

Key Inclusion Criteria: Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs) Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit History (by patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening For the 2 weeks prior to baseline visit, an average total symptom score (TSS) of at least of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severity score of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms, as defined in the protocol. Key Exclusion Criteria: Body weight less than 40 kg Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab Helicobacter pylori infection Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study Planned or anticipated use of any prohibited medications and procedures during the study Planned or anticipated major surgical procedure during the study Receiving tube feeding or parenteral nutritional at screening (Part A and B). NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Sites / Locations

  • Om Research LLCRecruiting
  • Om Research LLCRecruiting
  • United GastroenterologistsRecruiting
  • United Medical DoctorsRecruiting
  • Encore Borland-Groover Clinical ResearchRecruiting
  • GI Alliance - GurneeRecruiting
  • Boston SpecialistsRecruiting
  • Minnesota Gastroenterology, P.A.Recruiting
  • Long Island Gastrointestinal Research GroupRecruiting
  • Charlotte Gastroenterology & Hepatology, PLLCRecruiting
  • Great Lakes Gastroenterology Research, LLCRecruiting
  • Allergy, Asthma and Clinical Research CenterRecruiting
  • Galen Medical GroupRecruiting
  • Velocity Clinical ResearchRecruiting
  • Seattle Allergy and Asthma Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Phase 2

Part B: Phase 3

Part C: Extended Active Treatment Period

Arm Description

Randomized 1:1

Randomized 1:1:1

Participants from Part A and Part B, who continue to meet eligibility criteria, will be Randomized 1:1

Outcomes

Primary Outcome Measures

Proportion of participants achieving a peak gastric eosinophil count of ≤6 eosinophils/high power field (eos/hpf)
Part A and Part B
Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)
Part B Only EoG/EoD-SQ is a patient reported outcome (PRO) collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.

Secondary Outcome Measures

Proportion of participants achieving both a peak gastric eosinophil count of ≤6 eos/hpf and a peak duodenal eosinophil count of ≤15 eos/hpf
Part A, Part B and Part C
Proportion of participants achieving a peak duodenal eosinophil count of ≤15 eos/hpf
Part A, Part B and Part C
Absolute change in the EoG/EoD-SQ TSS
Part A and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Percent change in the EoG/EoD-SQ TSS
Part A, Part B and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Percent change in peak gastric tissue eosinophil count (eos/hpf)
Part A, Part B and Part C
Proportion of participants achieving a peak gastric tissue eosinophil count of <30 eos/hpf
Part A, Part B and Part C
Percent change in peak duodenal tissue eosinophil count (eos/hpf)
Part A, Part B and Part C: Assessed for only those with duodenal involvement
Proportion of participants achieving a peak duodenal tissue eosinophil count of <30 eos/hpf
Part A, Part B and Part C: Assessed for only those with duodenal involvement
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)
Part A, Part B and Part C EoGHSS scores evaluate 11 features of gastric tissue. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Total scores range from 0 - 1.
Change in frequency of diarrhea epispodes
Assessed for only those with diarrhea at baseline.
Change in frequency of vomiting episodes
Assessed for only those with vomiting at baseline
Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature
Part A, Part B and Part C: Assessed on gastric tissue Normalized Enrichment Score (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.
Change in the NES for the type 2 inflammation transcriptome signature
Part A, Part B and Part C: Assessed on duodenal tissue from participants with EoD 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.
Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature
Part A, Part B and Part C: Assessed on gastric tissue 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.
Proportion of participants who receive rescue medications or procedures
Part A, Part B and Part C
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eos/hpf
Part C
Incidence of treatment-emergent adverse events (TEAEs)
Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Incidence of treatment-emergent serious adverse events (SAEs)
Part A, Part B and Part C An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger) Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
Incidence of treatment-emergent adverse events of special interest (AESIs)
Part A, Part B and Part C An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
Incidence of TEAEs leading to permanent discontinuation of study treatment
Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Incidence of anti-drug antibody (ADA)
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Titer of ADA
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Incidence of neutralizing antibody (Nab) to dupilumab
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Concentrations of functional dupilumab in serum at each assessment time point from baseline to end of study
The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.

Full Information

First Posted
April 14, 2023
Last Updated
September 27, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05831176
Brief Title
A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
Acronym
ENGAGE
Official Title
A Phase 2/3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
August 19, 2027 (Anticipated)
Study Completion Date
August 19, 2027 (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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: What side effects may happen from taking the study drug How much study drug is in your blood at different times Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Exploratory research to better understand the study drug and EoG with or without EoD and related diseases.
Detailed Description
This trial will have 3 parts plus screening and follow-up parts: Parts A and B: Participants will either be included in part A or B. Each is a 24-week double-blind (this means none of the participants, doctors, or other trial staff will know what treatment each participant took) part where participants will receive either dupilumab or a placebo (a placebo looks like a trial drug but does not have any medicine in it). Part C: 28-week extension part that will include participants from parts A and B and all participants will receive dupilumab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastritis, Eosinophilic Duodenitis, Eosinophilic Gastrointestinal Disease
Keywords
Eosinophilic Gastritis (EoG) with or without Eosinophilic Duodenitis (EoD), Eosinophilic Gastrointestinal Disease (EGID)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
279 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Phase 2
Arm Type
Experimental
Arm Description
Randomized 1:1
Arm Title
Part B: Phase 3
Arm Type
Experimental
Arm Description
Randomized 1:1:1
Arm Title
Part C: Extended Active Treatment Period
Arm Type
Experimental
Arm Description
Participants from Part A and Part B, who continue to meet eligibility criteria, will be Randomized 1:1
Intervention Type
Drug
Intervention Name(s)
Dupilumab Dose 1
Other Intervention Name(s)
DUPIXENT®, REGN668, SAR231893
Intervention Description
Administered subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Dupilumab Dose 2
Other Intervention Name(s)
DUPIXENT®, REGN668, SAR231893
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eosinophils/high power field (eos/hpf)
Description
Part A and Part B
Time Frame
At Week 24
Title
Absolute change in the Eosinophilic Gastritis/Eosinophilic Duodenitis Symptom Questionnaire (EoG/EoD-SQ) Total Symptom Score (TSS)
Description
Part B Only EoG/EoD-SQ is a patient reported outcome (PRO) collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants achieving both a peak gastric eosinophil count of ≤6 eos/hpf and a peak duodenal eosinophil count of ≤15 eos/hpf
Description
Part A, Part B and Part C
Time Frame
At Week 24 and At Week 52
Title
Proportion of participants achieving a peak duodenal eosinophil count of ≤15 eos/hpf
Description
Part A, Part B and Part C
Time Frame
At Week 24 and At Week 52
Title
Absolute change in the EoG/EoD-SQ TSS
Description
Part A and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Percent change in the EoG/EoD-SQ TSS
Description
Part A, Part B and Part C EoG/EoD-SQ is a PRO collected daily via an eDiary. Symptoms are assessed using an 11-point numerical rating scale (0 through 10). Higher scores indicate a higher symptom burden. Symptom scores are summed on each day with a maximum daily score of 60. The TSS is calculated by averaging daily sum scores over 7 days, with a maximum TSS of 60.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Percent change in peak gastric tissue eosinophil count (eos/hpf)
Description
Part A, Part B and Part C
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Proportion of participants achieving a peak gastric tissue eosinophil count of <30 eos/hpf
Description
Part A, Part B and Part C
Time Frame
At Week 24 and At Week 52
Title
Percent change in peak duodenal tissue eosinophil count (eos/hpf)
Description
Part A, Part B and Part C: Assessed for only those with duodenal involvement
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Proportion of participants achieving a peak duodenal tissue eosinophil count of <30 eos/hpf
Description
Part A, Part B and Part C: Assessed for only those with duodenal involvement
Time Frame
At Week 24 and At Week 52
Title
Absolute change in EoG scores from the EoG Histology Scoring System (EoGHSS)
Description
Part A, Part B and Part C EoGHSS scores evaluate 11 features of gastric tissue. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Total scores range from 0 - 1.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Change in frequency of diarrhea epispodes
Description
Assessed for only those with diarrhea at baseline.
Time Frame
Baseline at Week 24 and Baseline at Week 52
Title
Change in frequency of vomiting episodes
Description
Assessed for only those with vomiting at baseline
Time Frame
Baseline at Week 24 and Baseline at Week 52
Title
Change in the Normalized Enrichment Scores (NES) for the type 2 inflammation transcriptome signature
Description
Part A, Part B and Part C: Assessed on gastric tissue Normalized Enrichment Score (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.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Change in the NES for the type 2 inflammation transcriptome signature
Description
Part A, Part B and Part C: Assessed on duodenal tissue from participants with EoD 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.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Change in the NES for the EoG disease (EoG diagnostic panel (EGDP]) transcriptome signature
Description
Part A, Part B and Part C: Assessed on gastric tissue 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.
Time Frame
Baseline to Week 24 and Baseline to Week 52
Title
Proportion of participants who receive rescue medications or procedures
Description
Part A, Part B and Part C
Time Frame
At Week 24 and At Week 52
Title
Proportion of participants achieving a peak gastric eosinophil count of ≤6 eos/hpf
Description
Part C
Time Frame
At Week 52
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to Week 52
Title
Incidence of treatment-emergent serious adverse events (SAEs)
Description
Part A, Part B and Part C An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger) Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is an important medical event
Time Frame
Up to Week 52
Title
Incidence of treatment-emergent adverse events of special interest (AESIs)
Description
Part A, Part B and Part C An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
Time Frame
Up to Week 52
Title
Incidence of TEAEs leading to permanent discontinuation of study treatment
Description
Part A, Part B and Part C A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to Week 52
Title
Incidence of anti-drug antibody (ADA)
Description
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Time Frame
Up to Week 52
Title
Titer of ADA
Description
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Time Frame
Up to Week 52
Title
Incidence of neutralizing antibody (Nab) to dupilumab
Description
Part A, Part B and Part C Immunogenicity will be characterized per drug molecule by ADA and NAb status
Time Frame
Up to Week 52
Title
Concentrations of functional dupilumab in serum at each assessment time point from baseline to end of study
Description
The concentrations of functional dupilumab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Time Frame
Baseline to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs) Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilic gastritis (EoG) at least 3 months prior to screening Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit History (by patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening For the 2 weeks prior to baseline visit, an average total symptom score (TSS) of at least of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severity score of at least 4 (on a scale of 0-10) per week for at least 2 of the 6 symptoms, as defined in the protocol. Key Exclusion Criteria: Body weight less than 40 kg Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab Helicobacter pylori infection Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome History of bleeding disorders, esophageal or gastric varices that, in the opinion of the investigator, would put the participant at undue risk for significant complications from an endoscopy procedure Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 4 weeks prior to the screening visit. Participants on a food-elimination diet must remain on the same diet throughout the study Planned or anticipated use of any prohibited medications and procedures during the study Planned or anticipated major surgical procedure during the study Receiving tube feeding or parenteral nutritional at screening (Part A and B). NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
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
Om Research LLC
City
Apple Valley
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
United Gastroenterologists
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Individual Site Status
Recruiting
Facility Name
Encore Borland-Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance - Gurnee
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Specialists
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlotte Gastroenterology & Hepatology, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Galen Medical Group
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Allergy and Asthma Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD Sharing Time Frame
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 made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

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