Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to test the effectiveness of a drug called Benralizumab in people diagnosed with Eosinophilic Gastritis (EG). Benralizumab is approved by the FDA for treatment of adolescents and adults with eosinophilic asthma but not other types of eosinophilic diseases.
Who can participate?
Children, teens and adults 12 to 60 years old with EG or with Eosinophilic Gastroenteritis (EGE) may be eligible to participate. EG and EGE are inflammatory diseases involving a combination of gastrointestinal locations including the esophagus, stomach, and small intestine. Involvement of the stomach (EG) is required to participate.
What will happen in the study?
There are three phases to the study. Each phase involve visits to Cincinnati Children’s Hospital Medical Center (CCHMC).
Screening phase: Involves one visit. The screening phase is to make sure you are eligible to take part in the study. It will involve an endoscopy to determine how your EG is doing.
Treatment phase: Involves four visits. You will be assigned by chance (like the flip of a coin) to receive Benralizumab or placebo. A placebo is an inactive substance. Neither you nor your study doctor will know whether you are receiving study drug (Benralizumab) or placebo. In the case of an emergency, you and your doctor will be able to know if you have been on drug or placebo. The study drug will be given as a subcutaneous injection (an injection under the skin) once every 4 weeks for 2 months (3 total injections). An endoscopy will be done at the end of this treatment phase.
Open Label phase: Upon completion of the treatment phase, you may choose to participate in the Open Label extension phase, in which you will receive treatment with Benralizumab for an additional 24 weeks. Open Label means that there is no placebo; all participants will receive the active drug in this part of the study. There are seven visits in the Open Label phase. The first visit will include an endoscopy at CCHMC and an injection of the study drug. Three additional visits will occur at CCHMC where you will receive the study drug. Two other visits will occur over the phone. The final visit will take place at CCHMC and will include an endoscopy.
Will I need to change my diet or other medications during the study?
Throughout the study you should follow the same diet that you were following before starting the study. You may continue to take the medications that you were taking before starting the study, but try not to take any new medications or change the dose of the medications that you are taking, if possible. If there are changes to your diet or medication at any time, you should contact a study staff member.
What are the good things that can happen from this research?
We hope to learn that the study drug Benralizumb is an effective treatment for EG and EGE. It has already been determined to be effective in the treatment of eosinophilic asthma.
What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with parents or guardians interested in learning more about the study.
Will you/your child be paid to be in this research study?
You will be paid for your time and travel expenses incurred throughout the study. You will receive $50 for each study visit including visits that take place over the phone. You will receive $100 for the visit that occurs at the end of the treatment phase. The total for completion of all study visits is $600. If the doctor requests any additional visits, you will be paid $50 for each of them. Additional compensation for travel is available to partially cover expenses for hotels and/or airfare.
Who should I contact for more information?
Cristin Murray-Petzold
Phone: 513-803-9079
Email: Cristin.MurrayPetzold@cchmc.org
Cincinnati Center for Eosinophilic Disorders
The Division of Allergy and Immunology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor:
Marc Rothenberg MD
Cincinnati Children’s Hospital Medical Center
Where can I find additional information?
ClinicalTrials.gov