Celiac Disease - Brooklyn NY

Summary:

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.

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

Qualified Participants May Receive:

You will be reimbursed $160.00 per visit for the following visits: Screening, Visits 1, 3-14, and 16. You will receive $500.00 per visit for Visits 2 and 15. You will also be paid for any visit besides the scheduled visit to the clinic, also known as an unscheduled visit. You will be paid $75 for each unscheduled visit. Please note that if you choose to stop your voluntary participation in this study before the final study visit, then your compensation for your study participation will also stop. You will be paid following each completed visit.