Who is the study sponsor?
Nicole Bragg2025-10-16T10:40:54-07:00Teva Branded Pharmaceutical Products LLC
What is a clinical trial?
Nicole Bragg2025-01-28T09:57:46-08:00A clinical trial is a study that helps researchers determine if a new treatment is safe and effective. All medications must go through multiple phases of clinical trials before they can be approved for the public.
What is a placebo, and why is it used?
Nicole Bragg2025-01-28T09:57:23-08:00A placebo is an inactive substance with no therapeutic effect that is used to help determine whether results are due to the study drug.
Has the study drug been tested in humans before?
Nicole Bragg2025-01-28T09:56:52-08:00Yes. TEV-53408 has been tested in healthy people and in a small number of patients with celiac disease in previous studies, and the drug was shown to be safe and well-tolerated.
How will the study drug be administered?
Nicole Bragg2025-01-28T09:49:16-08:00TEV-53408 will be given as a single injection under the skin in the abdomen (belly area).
What is the study drug (TEV-53408)?
Nicole Bragg2025-01-28T09:48:59-08:00The study drug, TEV-53408, is an antibody designed to block interleukin-15 (IL-15). In celiac disease patients, gluten consumption results in the production of IL-15 which triggers intestinal inflammation, leading to destruction of intestinal cells. The goal of TEV-53408 is to help reduce intestinal inflammation and tissue damage associated with celiac disease.