Eosinophilic esophagitis (EoE) is thought to be a type of allergy that is often caused by food. When someone with EoE eats or even inhales some things in the environment, a type of white blood cell called eosinophils collect in the esophagus. As these cells aren’t normally there, they can cause symptoms such as swallowing difficulties, stomach pain, and vomiting.  Right now, research is underway to develop a new treatment for EoE, and you may be able to take part. Qualified participants between the ages of 11 and 55 will receive the investigational drug or a placebo (a look-alike substance that has no active drug in it), study-related medical exams, and lab tests. Compensation for travel may also be available.

ORBIT is a clinical research study that will test the safety and effectiveness of an investigational drug for eosinophilic esophagitis (EoE) symptoms in people ages 11 to 55.

WHO MAY QUALIFY.

The study is open to those who meet the following criteria:

• Adolescents and adults ages 11 to 55
• Have historical evidence of eosinophilic esophagitis (EoE)
• Are not pregnant or do not plan to conceive a child, and are practicing an acceptable method of birth control
• Are able to attend study visits and capable of providing informed consent
• Experience vomiting, difficulty swallowing, or abdominal pain when eating

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Exclusion:  Subject has any condition or abnormality (including laboratory abnormalities), current or past, that, in the opinion of the principal investigator or medical monitor, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of EoE. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; cardiovascular, metabolic, or pulmonary disease; or previous gastroesophageal surgery. These should be discussed with the medical monitor.

Subject has used immunomodulatory therapy within 8 weeks prior to the qualifying EGD or between the qualifying EGD and baseline visit (Visit 1) or anticipates using immunomodulatory therapy during the treatment period (except for any ongoing regimen of allergy shots). Use of long-acting immunomodulatory therapy (eg, Rituxan) within 3 months of the qualifying EGD should be reviewed with the medical monitor.

Subject has been using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition within the 4 weeks prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or anticipates use during the treatment period; any temporary use (≤7 days) or initiation of new steroid treatment during the study should be documented and discussed with the medical monitor prospectively but cannot occur within 4 weeks of the final EGD.

STUDY SCHEDULE.

Participants in this study will need to:

• Participate in the 12-week study period, after completing between three and six weeks of screening
• Attend up to six scheduled clinic visits and one scheduled telephone call for follow-up
• Complete a brief daily diary using an electronic device

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