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 - R668-EGE-2213

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 285 人开始时间: 2023年6月14日最近更新: 2024年7月22日

试验速览

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•Male or female, =12 years of age (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 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 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, NOTE: Other protocol defined inclusion criteria apply

•Body weight <40 kg, Planned or anticipated use of any prohibited medications and procedures during the study, Receiving tube feeding or parenteral nutritional at screening (Part A and B), NOTE: Other protocol defined exclusion criteria apply, Planned or anticipated major surgical procedure during the study, 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 screening. Participants on a food-elimination diet must remain on the same diet throughout the study.

发起方

Regeneron Pharmaceuticals Inc.