Eosinophilic Esophagitis
Overview:
A Phase 2, Randomized, Double-Blind, Multi-Center, 3-Part Study in Adult and Adolescent Subjects With Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 10 mg and 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 10 mg and 20 mg Up to 52 Weeks
Inclusion Criteria:
The participant is ≥18 years of age (Part 1 only) or 12 to 17 years of age (Part 2 only) at the time of informed consent signing. Part 2 will enroll adolescent participants after a planned interim analysis of Part 1 and recommendation to proceed by the independent DMC.
The participant has the ability to swallow the study drug.
The participant must remain on a stable diet for at least 6 weeks prior to the Screening Period and is expected to remain on a stable diet during the course of the study; stable diet is defined as not initiating new elimination diets or reintroducing previously eliminated foods.
A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.
Exclusion Criteria:
The participant is on a pure liquid diet.
The participant has documented erosive esophagitis at the screening endoscopy.
The participant has other known causes of esophageal eosinophilia or either of the following conditions: hypereosinophilic syndrome, or eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome).
The participant has a documented diagnosis of eosinophilic gastritis, duodenitis, jejunitis, ileitis, proctitis, or colitis.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) or dysplastic changes in the esophagus.
The participant has a history of achalasia, Crohn's disease, ulcerative colitis, or celiac disease.
The participant has a known active Helicobacter pylori infection.
The participant has any other clinically significant structural conditions affecting the esophagus, including: esophageal varices, viral or fungal infection, and history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, cryotherapy to the esophagus, caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation), or esophageal surgery.
The participant has a history of surgery or non-EoE endoscopic intervention, such as gastric bypass, fundoplication, gastric sleeve, or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has gastric ulcer(s) or duodenal ulcer(s) within 4 weeks before the first dose of study drug.
Use of prescription or non-prescription PPIs within 2 months prior to the Screening Period.
Use of swallowed topical corticosteroid or budesonide oral suspension for EoE within 2 months prior to the Screening Period.
Use of systemic corticosteroid for any condition within 3 months prior to the Screening Period.
Use of inhaled or nasal glucocorticoids within 3 months prior to the Screening Period, except stable dose for at least 3 months prior to the Screening Period for any condition (should not be changed during the study).
Use of dupilumab within 3 months prior to the Screening Period.
The participant has used immunomodulatory therapy within 3 months prior to the Screening Period or anticipates using immunomodulatory therapy during the study (except for any ongoing regimen of allergy therapy).
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
