A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis

• Status: Not yet recruiting
• Trial end date: 2027-07-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to learn if dupilumab helps more than the placebo after 24 weeks (Part A) and if dupilumab at different doses helps more than the placebo after 24 weeks (Part B).

The secondary purpose of this study is

• to learn if dupilumab helps after 24 and 52 weeks (Part A, Part B and Part C)

• to learn if dupilumab is safe and well tolerated and if it causes an immune response (immunogenicity)

• to learn how dupilumab moves throughout the body (pharmacokinetics)

• to learn how dupilumab changes the patterns of certain genetic material related to eosinophilic gastritis (EoG) and type 2 inflammation (transcriptome signatures)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Antibodies, Monoclonal

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 diagnosis of Eosinophilic gastritis (EoG) by biopsy 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 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 in TSS.

Key Exclusion Criteria:

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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply