Phase
Condition
Gastroenteritis
Heartburn
Duodenal Ulcers
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
Mater Research Ltd
South Brisbane, Queensland 4101
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
Humanitas Research Hospital
Rozzano, Milan 20089
ItalySite Not Available
AOOR Villa Sofia/Cervello
Palermo, Sicily 90146
ItalySite Not Available
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
Bari, 70124
ItalySite Not Available
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca' Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan, 20162
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
Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, 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
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
ItalyActive - Recruiting
Iizuka Hospital
Iizuka, Fukuoka 820-8505
JapanSite Not Available
Ogaki Municipal Hospital
Ōgaki, Gifu 503-8502
JapanSite Not Available
Kure Kyosai Hospital
Kure, Hiroshima 737-8505
JapanSite Not Available
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyōgo 670-8560
JapanSite Not Available
Kobe University Graduate School of Medicine
Kobe, Hyōgo 650-0017
JapanSite Not Available
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken 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 105-8470
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
Centrum Medyczne Melita Medical
Wroclaw, 50449
PolandActive - Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Om Research LLC
Apple Valley, California 92307
United StatesSite Not Available
Scripps Clinic
La Jolla, California 92037
United StatesSite Not Available
Om Research LLC
Lancaster, California 93534
United StatesSite Not Available
GastroIntestinal BioSciences
Los Angeles, California 90067
United StatesSite Not Available
USC, Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
University of California - Los Angeles (UCLA)
Los Angeles, California 90024
United StatesSite Not Available
University of Southern California Keck School of Medicine
Los Angeles, California 90033
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
Scripps Memorial Hospital La Jolla
La Jolla 5363943, California 5332921 92037
United StatesActive - Recruiting
GastroIntestinal BioSciences
Los Angeles 5368361, California 5332921 90067
United StatesSite Not Available
University of California - Los Angeles (UCLA)
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
University of Southern California Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
University of Colorado Anschutz Health Science Building (AHSB) CU Research Pharmacy
Aurora, Colorado 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
Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
GI Alliance - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
University Of Kansas
Kansas City, Kansas 66103
United StatesSite Not Available
Meritus Center for Clinical Research
Hagerstown, Maryland 21742
United StatesSite Not Available
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston, Massachusetts 02215
United StatesSite Not Available
Boston Specialists
Boston, Massachusetts 02111
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center (BIDMC) Harvard Medical School
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
MNGI Digestive Health 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
Minnesota Gastroenterology, P.A.
Plymouth 5041926, Minnesota 5037779 55446
United StatesActive - Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska 68114
United StatesActive - Recruiting
Advanced Research Institute
Reno, Nevada 89511
United StatesSite Not Available
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 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
Northwell Health
Great Neck 5119218, New York 5128638 11021
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 27599
United StatesSite Not Available
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina 28207
United StatesSite Not Available
Duke University
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 275997080
United StatesActive - Recruiting
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
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
The Oregon Clinic - Gastroenterology East
Portland, Oregon 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
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
GI Alliance
Garland, Texas 75044
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
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
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
Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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