Protocol Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients with Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet.
Short Title: Phase 2b Study of PRV-015 in Gluten-free Diet Non-responsive Celiac Disease
Rationale: Non-responsive celiac disease (NRCD) can be defined as persistent symptoms, signs, or laboratory abnormalities typical of celiac disease despite at least 6-12 months of treatment with a gluten-free diet (GFD) (Rubio-Tapia 2013). PRV-015 (also known as AMG 714), a monoclonal antibody (mAb) that blocks interleukin 15 (IL-15), may reduce intestinal inflammation and improve clinical symptoms induced by gluten consumption in celiac disease. PRV-015 may be effective as an adjunctive treatment to a GFD in NRCD patients.
Criteria:18-70 years old
Biopsy-confirmed celiac disease
On a gluten-free diet for at least the last 12 months
Still experiencing celiac disease symptoms
Participants 18-70 years of age: have a diagnosis of celiac disease by intestinal biopsy at least 12 months prior: following a Gluten-free diet for 12 consecutive months: symptoms due to accidental gluten exposure: Experiencing symptoms associated with celiac disease