Eosinophilic Esophagitis (EoE) Digestive System
Conditions
Interventions
Part 1c of the study will comprise of a multicenter, double-blind, randomized, placebo-controlled, parallel arm design that compares the safety and tolerability of a single SC (subcutaneous) dose lev
Sponsors
AnaptysBio, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 70 years old 2. Willing and able to provide informed consent 3. Female participants must not be pregnant or lactating 4. Male participants must be willing to comply with protocol contraceptive requirements 5. Prior histologic documentation of EoE diagnosis 6. Absence of histologic response to at least 6 weeks of proton pump inhibitors (PPI) or documented intolerance to PPI. 7. Histologic evidence of EoE with peak eosinophil count =15/hpf, from 2 of 3 levels of the esophagus at the Screening endoscopy. 8. History of at least 4 episodes of dysphagia in the 2 weeks prior to Screening. 9. Willing to comply with necessary tests and protocol requirements
Exclusion criteria
Exclusion criteria: 1. Has signs, symptoms, or current diagnosis of concerning, severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, GI, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 2. Participant has a BMI of 35 kg/m² or total body weight <45 kg (99 lb) (Note: BMI = weight (kg)/[height (m)]²). 3. Participant smokes cigarettes or has quit smoking within 3 months of screening. 4. History of clinically significant drug or alcohol abuse 5. Clinically significant, abnormal 12-lead ECG 6. Planned surgery within 4 weeks prior to the start of screening 7. History of drug allergy, suspected medical condition, including autoimmune or inflammatory conditions, that currently requires or may require systemic immunomodulatory or immune suppressive therapy. 8. Predisposed to develop an infection 9. Positive for hepatitis B, hepatitis C and HIV-1 or HIV-2 antibodies 10. Diagnosis of, suspected diagnosis of, or concerns of acquiring active TB or currently with untreated latent TB.
Countries
Australia, Belgium, Canada, England, Germany, Italy, Netherlands, Norway, Spain, United Kingdom, United States of America
Contacts
Public ContactLewis Gryziewicz
Outcome results
None listed