Dupilumab in Eosinophilic Gastritis (NCT03678545) | Clinical Trial Compass
CompletedPhase 2
Dupilumab in Eosinophilic Gastritis
United States41 participantsStarted 2021-05-15
Plain-language summary
40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.
Who can participate
Age range12 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant and/or parent guardian must be able to understand and provide informed consent and/or assent.
✓. Willing and able to comply with study visits and activities
✓. Age ≥ 12 and \< 71 years at study enrollment
✓. Histologically active EG at time of screening, with a peak gastric count of ≥ 30 eos/hpf in at least 5 hpfs in the gastric antrum and/or body.
✓. History (by patient report) of moderate to severe EG symptoms
✓. Stable medical management of EG.
✓. Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy.
✓. If have asthma and/or any other chronic allergic conditions they must be willing to maintain their pretrial medications until the end of study. Medication dose can be increased if there is a deterioration in the condition.
Exclusion criteria
✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
✕. Current active H. pylori infection.
✕. Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease.
✕. Known or suspected active colitis in the Principal Investigator's opinion or by biopsy.
What they're measuring
1
Relative Change of Peak Eosinophil Counts in the Stomach
Timeframe: 12 weeks after randomization
Trial details
NCT IDNCT03678545
SponsorChildren's Hospital Medical Center, Cincinnati