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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
EU CTIS ID: 2022-500795-62-00
What this study is testing
To assess the efficacy of dupilumab treatment in adult and adolescent participants with eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD) after 24 weeks of treatment as assessed by histological outcome measures.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 or ethic committees (ECs))
- Documented endoscopic biopsy supporting a pathologic diagnosis of EoG at least 3 months prior to screening.
- Screening 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 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
- An average TTS 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
You likely can't join if
- Body weight <40 kg at screening
- Planned or anticipated use of any prohibited medications and procedures during the study
- Receiving tube feeding or parenteral nutritional at screening
- 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
See the full eligibility criteria
- 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 or ethic committees (ECs))
- Documented endoscopic biopsy supporting a pathologic diagnosis of EoG at least 3 months prior to screening.
- Screening 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 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
- An average TTS 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
- NOTE: Other protocol defined inclusion criteria apply
- Body weight <40 kg at screening
- Planned or anticipated use of any prohibited medications and procedures during the study
- Receiving tube feeding or parenteral nutritional at screening
- 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, as defined in the protocol
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.