Phase
Condition
Infectious Colitis
Colic
Ulcers
Treatment
Matching Placebo
Dupilumab Dose 2
Dupilumab Dose 1
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
Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for adiagnosis 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 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 atleast of 20 calculated using data from the EoG/EoD-SQ eDiary and an average severityscore 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.
Exclusion
Key Exclusion Criteria:
Body weight less than 40 kg
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
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 (Part A and B).
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
Mater Research Ltd
South Brisbane, Queensland 4101
AustraliaSite Not Available
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland 4102
AustraliaSite Not Available
St. Vincent's Hospital
Fitzroy, 3065
AustraliaSite Not Available
Joondalup Health Campus
Joondalup, 6027
AustraliaSite Not Available
Coral Sea Clinical Research Institute
North Mackay, 4740
AustraliaSite Not Available
University Of Alberta
Edmonton, Alberta T6G 1Z1
CanadaActive - Recruiting
U.O. Di Ematologia-Azienda Policlinico Consorziale, Ospedaliero-Universitaria, Ospedale
Bari, 70124
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalyActive - Recruiting
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
ItalyActive - Recruiting
Ospedale S Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, 00186
ItalyActive - Recruiting
Sapienza - University of Rome
Rome, 00161
ItalyActive - Recruiting
Humanitas Research Hospital
Rozzano, 20089
ItalyActive - Recruiting
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089
ItalyActive - Recruiting
Iizuka Hospital
Iizuka, Fukuoka 820-8505
JapanActive - Recruiting
Aso Iizuka Hospital
Iizuka-shi, Fukuoka 820-8502
JapanSite Not Available
Ogaki Municipal Hospital
Ogaki, Gifu 503-8502
JapanActive - Recruiting
Isesaki Municipal Hospital
Isesaki-shi, Gunma 372-0817
JapanActive - Recruiting
Kure Kyosai Hospital
Kure-shi, Hiroshima 737-8505
JapanActive - Recruiting
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji, Hyogo 670-8560
JapanActive - Recruiting
Kobe University Hospital
Kobe-shi, Hyogo 650-0017
JapanActive - Recruiting
Yokohama City University Hospital
Yokohama-shi, Kanagawa 236-0004
JapanActive - Recruiting
Kawasaki Medical School Hospital
Kurashiki, Okayama 701-0192
JapanActive - Recruiting
Kawasaki Medical School Hospital
Kurashiki City, Okayama 701-0192
JapanSite Not Available
Federation of National Public Service Personnel Mutual Aid Associations Toranomon Hospital
Minato-ku, Tokyo 105-8470
JapanActive - Recruiting
Yamagata University Hospital
Yamagata-shi, Yamagata 990-9585
JapanActive - Recruiting
Wip Warsaw Ibd Point Profesor Kierkus
Warszawa, Mazowieckie 00-728
PolandActive - Recruiting
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
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesActive - Recruiting
Om Research LLC
Apple Valley, California 92307
United StatesActive - Recruiting
Scripps Memorial Hospital La Jolla
La Jolla, California 92037
United StatesActive - Recruiting
Om Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
United Gastroenterologists
Los Alamitos, California 90720
United StatesActive - Recruiting
GastroIntestinal BioSciences
Los Angeles, California 90067
United StatesActive - Recruiting
USC, Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
United Medical Doctors
Murrieta, California 92563
United StatesActive - Recruiting
University of California San Francisco
San Francisco, California 94158
United StatesActive - Recruiting
Connecticut Clinical Research Institute
Bristol, Connecticut 06010
United StatesActive - Recruiting
Uconn Health
Farmington, Connecticut 06030
United StatesActive - Recruiting
Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
GI Alliance - Gurnee
Gurnee, Illinois 60031
United StatesActive - Recruiting
The University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University Of Kansas
Kansas City, Kansas 66103
United StatesActive - Recruiting
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 StatesActive - Recruiting
Boston Specialists
Boston, Massachusetts 02111
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska 68114
United StatesActive - Recruiting
Advanced Research Institute
Reno, Nevada 89511
United StatesActive - Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756-0001
United StatesActive - Recruiting
Long Island Gastrointestinal Research Group
Great Neck, New York 11023
United StatesSite Not Available
Northwell Health
Great Neck, New York 11021
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York 10029
United StatesActive - Recruiting
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Duke University Health System
Durham, North Carolina 27710
United StatesActive - Recruiting
ESI Medical Research, PLLC
Kinston, North Carolina 28513
United StatesActive - Recruiting
University of Cincinnati Medical Center-Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Ohio State Univeristy Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Ohio State University Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United StatesSite Not Available
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
The Oregon Clinic - Gastroenterology East
Portland, Oregon 97220
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Galen Medical Group
Hixson, Tennessee 37343
United StatesSite Not Available
Vanderbilt University Medical Center-Digestive Disease Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
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 StatesActive - Recruiting
The University of Utah Health Sciences Center
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Velocity Clinical Research
West Jordan, Utah 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 StatesActive - Recruiting
Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.