A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have

Launched by REGENERON PHARMACEUTICALS · Apr 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dupilumab to see if it is safe and effective for adults and teens (ages 12 and older) with eosinophilic gastritis (EoG), a rare condition where a type of white blood cell called eosinophils build up in the stomach and cause inflammation and discomfort. The trial specifically includes participants who have EoG with or without eosinophilic duodenitis (EoD), but those with EoD alone cannot join. To be eligible, participants need to have a confirmed diagnosis of EoG through a medical procedure called an endoscopy, and they should have been experiencing symptoms related to the condition frequently over the past few weeks.

If you or a loved one decides to participate, you will be monitored for any potential side effects from the medication, and the study will also check how much of the drug is in your system at different times. Participants will be compared to a group receiving a placebo, which looks like the drug but has no active ingredients. This study is currently recruiting, so if you meet the criteria and are interested, it may be a chance to contribute to important research while exploring a possible treatment for EoG.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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. Screening 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 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
• • 6. An average TSS of ≥ 20 calculated using data collected via the EoG/EoD-SQ eDiary per week for the 2 weeks prior to baseline. An average severity score of ≥4 (on a scale of 0-10) per week for the 2 weeks prior to baseline for at least 2 of the 6 symptoms, as defined in the protocol.
• Key Exclusion Criteria:
• • 1. Body weight less than 40 kg at screening
• • 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, as defined in the protocol
• • 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
• • NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply