EOSINOPHILIC GASTROENTERITIS
TITLE: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti- IL4RA) in Subjects with Eosinophilic Gastritis
SPONSOR: REGENERON
Primary Investigator: Dr. Falk
CONTACT: Christine Gepty, BSN, RN (christine.gepty@pennmedicine.upenn.edu or 215-349-8556)
Criteria
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.
- Score on Asthma Control Test (ACTTM) ≥ 20
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.
- Hypereosinophilic syndrome.
- History of cancer
- Current or recent use of biological agents.
- Leukocyte count has not returned to the relevant lower limit of normal after discontinuing cell depleting biological agents.
- Current or recent use of any investigational drug.
- Current use of systemic steroids with daily dose > 10 mg for any reason or steroid burst for > 3 days within 1 month of screening.
- Prior exposure to dupilumab.
- History of anaphylaxis to any biologic therapy.
- Current pregnancy or breastfeeding.
- Ocular disorder.
- Individuals who have required use of a systemic corticosteroid for asthma.
- Received live vaccine 30 days prior to screening or planning on receiving a live vaccine during the time period that he/she is participating in the study.
- Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope.
- History of bleeding disorders or esophageal varices.
- Active parasitic infection.
- History of alcohol or drug abuse within 6 months prior to screening.
- Participant or his/her immediate family is a member of the investigational team.
- Planned or anticipated major surgical procedure during the study.
- Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening.
- Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening.
- Treatment with oral immunotherapy (OIT) within 6 months prior to screening.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals or antifungals within 2 weeks before the baseline visit
- Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV).
- Planned or anticipated use of any prohibited medications and procedures during the study.
- Initiation, discontinuation or change in the dosage regimen of the following Proton pump inhibitors (PPIs) Leukotriene inhibitors Nasal and/or inhaled corticosteroids
- Women of childbearing potential who are unwilling to practice highly effective contraception.