A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis (ENGAGE)
Eosinophilic Gastritis, Eosinophilic Duodenitis, Eosinophilic Gastrointestinal Disease
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
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
Experimental
Experimental
Experimental
Part A: Phase 2
Part B: Phase 3
Part C: Extended Active Treatment Period
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