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Dupilumab in Eosinophilic Gastritis With or Without Eosinophilic Duodenitis
NCT05831176Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- May 2023
- Primary completion
- Feb 2026
- Countries
- 4
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Monoclonal Antibodies
- Drugs
- dupilumab
- Conditions
- eosinophilic gastritis (EG)eosinophilic duodenitis (EoD)
01
Overview
Phase 2, open-label, single-arm trial of dupilumab in eosinophilic gastritis (EG) and eosinophilic duodenitis (EoD), sponsored by Regeneron Pharmaceuticals. Primary endpoint: Percent change in peak gastric eosinophil count at 24 weeks. Started May 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Dupilumab
Participants receive dupilumab during Part A and, if eligible, continue in Part C.
03
Who it enrols
Patients aged 12 and older with active eosinophilic gastritis (with or without eosinophilic duodenitis), weighing at least 40 kg. Excludes patients with H. pylori infection, specific gastrointestinal disorders, or prior dupilumab use.
04
Endpoints
Primary
Percent change in peak gastric eosinophil count
Secondary
Percent change in peak gastric eosinophil count
Proportion of participants achieving a peak gastric eosinophil count of <=20 eos/hpf
Proportion of participants achieving a peak gastric eosinophil count of <=30 eos/hpf
Proportion of participants achieving both a peak gastric eosinophil count of <=20 eos/hpf and a peak duodenal eosinophil count of <=30 eos/hpf
Proportion of participants achieving a peak duodenal eosinophil count of <=30 eos/hpf
Absolute change in the EoG/EoD-SQ Total Symptom Score
Percent change in the EoG/EoD-SQ Total Symptom Score
Percent change in peak duodenal tissue eosinophil count
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