A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

Inclusion Criteria:

• Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
• On a gluten-free diet for at least 12 months
• Negative celiac serology
• Avoidance of pregnancy

Exclusion Criteria:

• Severe complications of celiac disease, such as refractory celiac disease
• Celiac symptoms
• Other concomitant autoimmune disease
• Chronic, active gastrointestinal disease
• Infections, concomitant diseases
• Prohibited medications