Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ception Therapeutics
Age
5–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
written informed consent obtained
male or female patients aged 5 to 18 years at time of screening
of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol
confirmed active EE (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (hpf; 400X magnification)
within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing
been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)
You may not be if
another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome \[HES\],Churg Strauss vasculitis, eosinophilic gastroenteritis \[EG\], or a parasitic infection)
history of abnormal gastric or duodenal biopsy or documented gastrointestinal \[GI\] disorders (e.g., celiac disease, Crohn's disease or Helicobacter pylori infection)
history of the following GI surgeries: fundoplication, gastric surgery or surgery for intestinal atresia
use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E \[IgE\] monoclinal antibody \[mAb\], methotrexate, cyclosporin, interferon alpha \[α\], or anti tumor necrosis factor \[TNF\] mAb) within six months prior to study entry
received attenuated live attenuated vaccines (e.g., measles, mumps, rubella \[MMR\], bacillus Calmette-Guerin \[BCG\], varicella, FluMist or polio) within three months prior to study entry
use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study
a stricture on endoscopy that prevents passage of the endoscope
participation in any investigational drug or device study within 30 days prior to study entry
female subjects who are pregnant or nursing
concurrent infection or disease that may preclude assessment of EE
concurrent immunodeficiency (human immunodeficiency \[HIV\], or acquired immunodeficiency syndrome \[AIDS\] or congenital immunodeficiency)
