Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory 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 Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma

Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.

Inclusion Criteria:

• Confirmed diagnosis of refractory celiac disease Type II (RCD-II)
• Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow cytometry
• On a gluten-free diet for at least 6 months
• Avoid pregnancy

Exclusion Criteria:

• Enteropathy-Associated T cell Lymphoma (EATL)
• Infections
• Immune suppression
• Clinically significant co-morbidities