Phase
Condition
Stomach Discomfort
Gastrointestinal Diseases And Disorders
Bowel Dysfunction
Treatment
Matching Placebo
Dupilumab
Dupilumab Dose 2
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Adolescent participants will only be enrolled at study sites in countries/regions aspermitted by local regulatory authorities and ethic committees (ECs)
Documented endoscopic biopsy supporting a pathologic diagnosis of Eosinophilicgastritis (EoG) at least 3 months prior to screening
Screening endoscopic biopsies with a demonstration of eosinophilic infiltration fora 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 weeksprior to the baseline visit
History (by participant report) of at least 2 episodes of EoG (with or without EoD)symptoms per week in 8 weeks before screening, as defined in the protocol
An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary perweek for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scaleof 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6symptoms, as defined in the protocol.
Exclusion
Key Exclusion Criteria:
Body weight less than 40 kg at screening
Prior participation in a dupilumab clinical trial, or past or current treatment withdupilumab
Helicobacter pylori infection
Any esophageal stricture unable to be passed with a standard, diagnostic, upperendoscope 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, as defined in the protocol
Other causes of gastric and, if applicable, duodenal eosinophilia or the followingconditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)or hyper-eosinophilic syndrome
History of bleeding disorders, esophageal or gastric varices that, in the opinion ofthe investigator, would put the participant at undue risk for significantcomplications from an endoscopy procedure
Initiation or change of a food-elimination diet regimen or re-introduction of apreviously 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 thestudy
Planned or anticipated use of any prohibited medications and procedures during thestudy
Planned or anticipated major surgical procedure during the study
Receiving tube feeding or parenteral nutritional at screening
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Study Design
Study Description
Connect with a study center
Nepean Clinical School
Kingswood, New South Wales 2747
AustraliaSite Not Available
Nepean Hospital
Kingswood, New South Wales 2747
AustraliaSite Not Available
Nepean Hospital
Kingswood 2161303, New South Wales 2155400 2747
AustraliaSite Not Available
Mater Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Mater Research Ltd
South Brisbane, Queensland 4101
AustraliaSite Not Available
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Mater Hospital
South Brisbane 2207259, Queensland 2152274 4101
AustraliaSite Not Available
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba 6943568, Queensland 2152274 4102
AustraliaSite Not Available
St. Vincent's Hospital
Fitzroy, 3065
AustraliaSite Not Available
St. Vincent's Hospital
Fitzroy 2166584, 3065
AustraliaSite Not Available
Joondalup Health campus
Joondalup, 6027
AustraliaSite Not Available
Joondalup Health Campus
Joondalup 6695255, 6027
AustraliaSite Not Available
Coral Sea Clinical Research Institute
North Mackay, 4740
AustraliaSite Not Available
Coral Sea Clinical Research Institute
North Mackay 2154917, 4740
AustraliaSite Not Available
Stollery Children's Hospital - University of Alberta
Edmonton, Alberta T6G 1C9
CanadaSite Not Available
University Of Alberta
Edmonton, Alberta T6G 1Z1
CanadaActive - Recruiting
Stollery Children's Hospital - University of Alberta
Edmonton 5946768, Alberta 5883102 T6G 1C9
CanadaSite Not Available
Humanitas Research Hospital
Rozzano, Milan 20089
ItalySite Not Available
Humanitas Research Hospital
Rozzano 3168837, Milan 20089
ItalySite Not Available
AOOR Villa Sofia/Cervello
Palermo, Sicilia 90146
ItalySite Not Available
AOOR Villa Sofia/Cervello
Palermo 2523920, Sicily 2523119 90146
ItalySite Not Available
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
Bari, 70124
ItalySite Not Available
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
Bari 3182351, 70124
ItalySite Not Available
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan 6951411, 20162
ItalySite Not Available
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalyActive - Recruiting
Ospedali Riuniti Villa Cervello
Palermo, 90146
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa 3170647, 56124
ItalySite Not Available
Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, 00186
ItalySite Not Available
Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma 8957247, 00186
ItalySite Not Available
Sapienza - University of Rome
Rome, 00161
ItalyActive - Recruiting
University of Rome - Pediatric Gastroenterology and Liver Unit
Rome, 00161
ItalySite Not Available
University of Rome - Pediatric Gastroenterology and Liver Unit
Rome 3169070, 00161
ItalySite Not Available
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
ItalyActive - Recruiting
Iizuka Hospital
Iizuka, Fukuoka 820-8505
JapanSite Not Available
Aso Iizuka Hospital
Iizuka-shi, Fukuoka 820-8502
JapanSite Not Available
Iizuka Hospital
Iizuka 1861835, Fukuoka 1863958 820-8505
JapanSite Not Available
Ogaki Municipal Hospital
Ogaki, Gifu 503-8502
JapanSite Not Available
Ogaki Municipal Hospital
Ōgaki 1854703, Gifu 1863640 503-8502
JapanSite Not Available
Isesaki Municipal Hospital
Isesaki, Gunma 372-0817
JapanSite Not Available
Isesaki Municipal Hospital
Isesaki-shi, Gunma 372-0817
JapanSite Not Available
Isesaki Municipal Hospital
Isesaki 1861436, Gunma 1863501 372-0817
JapanSite Not Available
Kure Kyosai Hospital
Kure, Hiroshima 737-8505
JapanSite Not Available
Kure Kyosai Hospital
Kure-shi, Hiroshima 737-8505
JapanSite Not Available
Kure Kyosai Hospital
Kure 1858296, Hiroshima 1862413 737-8505
JapanSite Not Available
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyogo 670-8560
JapanSite Not Available
Kobe University Hospital
Kobe-shi, Hyogo 650-0017
JapanSite Not Available
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji 1862627, Hyōgo 1862047 670-8560
JapanSite Not Available
Kobe University Graduate School of Medicine
Kobe 1859171, Hyōgo 1862047 650-0017
JapanSite Not Available
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Yokohama City University Hospital
Yokohama-shi, Kanagawa 236-0004
JapanSite Not Available
Yokohama City University Hospital
Yokohama 1848354, Kanagawa 1860291 236-0004
JapanSite Not Available
Kawasaki Medical School Hospital
Kurashiki, Okayama 701-0192
JapanSite Not Available
Kawasaki Medical School Hospital
Kurashiki City, Okayama 701-0192
JapanSite Not Available
Kawasaki Medical School Hospital
Kurashiki 1858311, Okayama-ken 1854381 701-0192
JapanSite Not Available
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Minato-ku, Tokyo 105-8470
JapanActive - Recruiting
Toranomon Hospital
Minato-ku, Tokyo 1850144 105-8470
JapanSite Not Available
Yamagata University Hospital
Yamagata-shi, Yamagata 990-9585
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanSite Not Available
Yamagata University Hospital
Yamagata 2110556, 990-9585
JapanSite Not Available
Wip Warsaw Ibd Point Profesor Kierkus
Warsaw 756135, Masovian Voivodeship 858787 00-728
PolandSite Not Available
Wip Warsaw Ibd Point Profesor Kierkus
Warszawa, Mazowieckie 00-728
PolandSite Not Available
Korczowski Bartosz - Gabinet Lekarski
Rzeszow, Podkarpackie 35-302
PolandSite Not Available
Korczowski Bartosz - Gabinet Lekarski
Rzeszów 759734, Podkarpackie Voivodeship 858788 35-302
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
PolandSite Not Available
Centrum Medyczne Melita Medical
Wroclaw, 50449
PolandActive - Recruiting
Melita Medical
Wroclaw, 50-449
PolandSite Not Available
Melita Medical
Wroclaw 3081368, 50-449
PolandSite Not Available
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Om Research LLC
Apple Valley, California 92307
United StatesSite Not Available
Scripps Memorial Hospital La Jolla
La Jolla, California 92037
United StatesSite Not Available
Om Research LLC
Lancaster, California 93534
United StatesSite Not Available
United Gastroenterologists
Los Alamitos, California 90720
United StatesSite Not Available
GastroIntestinal BioSciences
Los Angeles, California 90067
United StatesActive - Recruiting
USC, Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
University of California - Los Angeles (UCLA)
Los Angeles, California 90095
United StatesSite Not Available
United Medical Doctors
Murrieta, California 92563
United StatesSite Not Available
Ucsf Medical Center (Benioff Childrens Hospital)
San Francisco, California 94158
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94158
United StatesActive - Recruiting
Om Research LLC
Apple Valley 5324363, California 5332921 92307
United StatesSite Not Available
Scripps Clinic
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
Scripps Memorial Hospital La Jolla
La Jolla 5363943, California 5332921 92037
United StatesActive - Recruiting
Om Research LLC
Lancaster 5364940, California 5332921 93534
United StatesSite Not Available
United Gastroenterologists
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
GastroIntestinal BioSciences
Los Angeles 5368361, California 5332921 90067
United StatesSite Not Available
University of California - Los Angeles (UCLA)
Los Angeles 5368361, California 5332921 90024
United StatesSite Not Available
University of Southern California Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
United Medical Doctors
Murrieta 5375911, California 5332921 92563
United StatesSite Not Available
Ucsf Medical Center (Benioff Childrens Hospital)
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Connecticut Clinical Research Institute
Bristol, Connecticut 06010
United StatesSite Not Available
Uconn Health
Farmington, Connecticut 06030
United StatesSite Not Available
Connecticut Clinical Research Institute
Bristol 5282835, Connecticut 4831725 06010
United StatesSite Not Available
UConn Health
Farmington 4834272, Connecticut 4831725 06030
United StatesSite Not Available
Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
United StatesSite Not Available
Encore Borland-Groover Clinical Research
Jacksonville 4160021, Florida 4155751 32256
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
GI Alliance - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
Gi Alliance
Gurnee, Illinois 60031
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Gi Alliance
Gurnee 4894861, Illinois 4896861 60031
United StatesSite Not Available
The University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
The University of Iowa Hospitals & Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University Of Kansas
Kansas City, Kansas 66103
United StatesSite Not Available
University Of Kansas
Kansas City 4273837, Kansas 4273857 66103
United StatesSite Not Available
Meritus Center for Clinical Research
Hagerstown, Maryland 21742
United StatesSite Not Available
Meritus Medical Center
Hagerstown, Maryland 21742
United StatesSite Not Available
Meritus Medical Center
Hagerstown 4357141, Maryland 4361885 21742
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston, Massachusetts 02215
United StatesActive - Recruiting
Boston Specialists
Boston, Massachusetts 02111
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Boston Specialists
Boston 4930956, Massachusetts 6254926 02111
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Hospital Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
MNGI Digestive Health P.A.
Plymouth 5041926, Minnesota 5037779 55446
United StatesSite Not Available
Minnesota Gastroenterology, P.A.
Plymouth 5041926, Minnesota 5037779 55446
United StatesActive - Recruiting
Mayo Clinic Hospital Rochester
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Children's Hospital & Medical Center
Omaha, Nebraska 68114
United StatesActive - Recruiting
Children's Hospital and Medical Center
Omaha, Nebraska 68114
United StatesSite Not Available
Children's Hospital and Medical Center
Omaha 5074472, Nebraska 5073708 68114
United StatesSite Not Available
Advanced Research Institute
Reno, Nevada 89511
United StatesSite Not Available
Advanced Research Institute
Reno 5511077, Nevada 5509151 89511
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756-0001
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
United StatesSite Not Available
Long Island Gastrointestinal Research Group
Great Neck, New York 11023
United StatesSite Not Available
Northwell Health
Great Neck, New York 11021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York 10029
United StatesSite Not Available
Long Island Gastrointestinal Research Group
Great Neck 5119218, New York 5128638 11023
United StatesSite Not Available
Northwell Health
Great Neck 5119218, New York 5128638 11021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York 5128581, New York 5128638 10029
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 275997080
United StatesSite Not Available
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina 28207
United StatesSite Not Available
Duke University Health System
Durham, North Carolina 27710
United StatesSite Not Available
ESI Medical Research, PLLC
Kinston, North Carolina 28513
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte 4460243, North Carolina 4482348 28207
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
ESI Medical Research, PLLC
Kinston 4474436, North Carolina 4482348 28513
United StatesSite Not Available
University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Ohio State Univeristy Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Ohio State University Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United StatesSite Not Available
University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Great Lakes Gastroenterology Research, LLC
Mentor 5162645, Ohio 5165418 44060
United StatesSite Not Available
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Allergy, Asthma and Clinical Research Center
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesSite Not Available
The Oregon Clinic - Gastroenterology East
Portland, Oregon 97220
United StatesSite Not Available
The Oregon Clinic - Gastroenterology East
Portland 5746545, Oregon 5744337 97220
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Galen Medical Group
Hixson, Tennessee 37343
United StatesSite Not Available
Vanderbilt University Medical Center-Digestive Disease Center
Nashville, Tennessee 37232
United StatesSite Not Available
Galen Medical Group
Hixson 4629825, Tennessee 4662168 37343
United StatesSite Not Available
Vanderbilt University Medical Center-Digestive Disease Center
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
GI Alliance
Garland, Texas 75044
United StatesSite Not Available
GI Alliance Research - Garland
Garland, Texas 75044
United StatesSite Not Available
Envision Clinical Research Lcc
Laredo, Texas 78041
United StatesSite Not Available
Laredo Medical Center
Laredo, Texas 78041
United StatesSite Not Available
TDDC dba GI Alliance Research
Mansfield, Texas 76063
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
GI Alliance Research - Garland
Garland 4693003, Texas 4736286 75044
United StatesSite Not Available
Envision Clinical Research Lcc
Laredo 4705349, Texas 4736286 78041
United StatesSite Not Available
TDDC dba GI Alliance Research
Mansfield 4709013, Texas 4736286 76063
United StatesSite Not Available
The University of Utah Health Sciences Center
Salt Lake City, Utah 84108
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Velocity Clinical Research
West Jordan, Utah 84088
United StatesSite Not Available
University of Utah
Salt Lake City 5780993, Utah 5549030 84132
United StatesSite Not Available
Velocity Clinical Research
West Jordan 5784549, Utah 5549030 84088
United StatesSite Not Available
Seattle Allergy and Asthma Research Institute
Seattle, Washington 98115
United StatesSite Not Available
Seattle Children's Home Health Company
Seattle, Washington 98105
United StatesSite Not Available
Seattle Allergy and Asthma Research Institute
Seattle 5809844, Washington 5815135 98115
United StatesSite Not Available
Seattle Children's Home Health Company
Seattle 5809844, Washington 5815135 98105
United StatesSite Not Available
Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Froedtert Hospital
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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