Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||12 Years - 70 Years|
Inclusion Criteria:1. Participant and/or parent guardian must be able to understand and provide informed consent and/or assent. 2. Willing and able to comply with study visits and activities. 3. Age ≥ 12 and < 71 years at study enrollment. 4. 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. 5. History (by patient report) of moderate to severe EG symptoms. 6. Stable medical management of EG. 7. Willing to maintain current dietary regimen throughout the course of the study. Diet must have been stable for 8 weeks prior to baseline endoscopy. 8. 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. 9. Score on Asthma Control Test (ACTTM) ≥ 20.
Exclusion Criteria:1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol. 2. Current active H. pylori infection. 3. Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease. 4. Known or suspected active colitis in the Principal Investigator's opinion or by biopsy. 5. Hypereosinophilic syndrome. 6. History of cancer. 7. Current or recent use of biological agents. 8. Leukocyte count has not returned to the relevant lower limit of normal after discontinuing cell depleting biological agents. 9. Current or recent use of any investigational drug. 10. Current use of systemic steroids with daily dose > 10 mg for any reason or steroid burst for > 3 days within 1 month of screening. 11. Prior exposure to dupilumab. 12. History of anaphylaxis to any biologic therapy. 13. Current pregnancy or breastfeeding. 14. Ocular disorder. 15. Individuals who have required use of a systemic corticosteroid for asthma. 16. 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. 17. Any esophageal stricture unable to be passed with a standard, diagnostic upper endoscope. 18. History of bleeding disorders or esophageal varices. 19. Active parasitic infection. 20. History of alcohol or drug abuse within 6 months prior to screening. 21. Participant or his/her immediate family is a member of the investigational team. 22. Planned or anticipated major surgical procedure during the study. 23. Initiation, discontinuation or addition of allergens to subcutaneous immunotherapy (SCIT) within 12 months prior to screening. 24. Treatment with sublingual immunotherapy (SLIT) within 6 months prior to screening. 25. Treatment with oral immunotherapy (OIT) within 6 months prior to screening. 26. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals or antifungals within 2 weeks before the baseline visit. 27. Known or suspected immunodeficiency disorder, including human immunodeficiency disorder (HIV). 28. Planned or anticipated use of any prohibited medications and procedures during the study. 29. Initiation, discontinuation or change in the dosage regimen of the following Proton pump inhibitors (PPIs) Leukotriene inhibitors Nasal and/or inhaled corticosteroids. 30. Women of childbearing potential who are unwilling to practice highly effective contraception.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Children's Hospital Medical Center, Cincinnati|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Other, Industry, NIH|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Eosinophilic Gastritis, Eosinophilic Gastroenteritis|
This is a phase 2, multi-center, randomized, double-blind, placebo-controlled trial testing the efficacy of dupilumab vs.#46; placebo in EG. Qualifying subjects will be randomized 1:1 to either study drug (dupilumab) or placebo, and will receive 600 mg once followed by 300 mg doses every two weeks of study treatment for a total of 6 injections. After the 6th injection subjects may continue into an open-label treatment phase in which dupilumab will be administered every two weeks for a total of 24 weeks. Approximately 14 sites associated with the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) will take part in the study. The primary objective of this study is to assess the efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with EG.
Active Comparator: Dupilumab
Placebo Comparator: Placebo
Drug: - Dupilumab (blinded)
Subcutaneous injection every two weeks as follows: 600 mg initial dose, and 300 mg subsequent doses for a total of 6 injections.
Drug: - Placebo (blinded)
Placebo is matched to the active drug (dupilumab), and is given in the same manner: a subcutaneous injection every two weeks for a total of 6 injections.
Drug: - Dupilumab (open-label)
After completing 6 doses of blinded study drug (dupilumab or placebo), participants can continue into the open-label portion of the study, in which all subjects will receive 12 doses (every 2 weeks for 24 weeks) of dupilumab.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.