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 - ENGAGE

Shabbir Arsalan Q.0 个研究点目标入组 32 人开始时间: 2023年12月26日最近更新: 2024年4月1日

试验速览

暂无简介。

•1. Adolescent participants will only be enrolled at study sites in countries/regions as permitted by local regulatory authorities and ethic committees (ECs)
•2. Documented endoscopic biopsy supporting a pathologic diagnosis of eosinophilic gastritis (EoG) at least 3 months prior to screening
•3. Baseline endoscopic biopsies with a demonstration of eosinophilic infiltration for a diagnosis of EoG, as defined in the protocol
•4. Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit
•5. History (by patient report) of at least 2 episodes of EoG (with or without EoD) symptoms per week in 8 weeks before screening
•6. 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.
•NOTE: Other Protocol Defined Inclusion Criteria Apply

•1. Body weight less than 40 kg
•2. Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
•3. Helicobacter pylori infection
•4. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
•5. History of achalasia, Crohn's disease, eosinophilic colitis, ulcerative colitis, celiac disease, and prior gastric or duodenal surgery
•6. Other causes of gastric and, if applicable, duodenal eosinophilia or the following conditions: eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) or hyper-eosinophilic syndrome
•7. 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
•8. 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
•9. Planned or anticipated use of any prohibited medications and procedures during the study
•10. Planned or anticipated major surgical procedure during the study
•11. Receiving tube feeding or parenteral nutritional at screening (Part A and B).
•NOTE: Other Protocol Defined Exclusion Criteria Apply

发起方

Shabbir Arsalan Q.