Full Study Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy (Study 3031)

The Primary Objective is to assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in patients with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.

Full Study Title: An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease.

This study is designed to find out if having the medical conditions Ulcerative Colitis or Crohn’s Disease affects the way commonly used medications are broken down in the body.

Microbes that live inside the human body provide a wide range of functions that the human body lacks. However, they are also linked to diseases, such as Crohn's disease and ulcerative colitis (collectively called inflammatory bowel disease, or IBD). Recently, it has been shown that newborns carry bacteria transferred from their mothers. We would like to determine how and when maternal bacteria are transferred to a baby from mothers with and without IBD. This information can help us develop novel strategies to limit risk transmission from a mother to a baby.

The primary objective of this study is to observe the long-term safety of Filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored Filgotinib treatment study in Crohn's disease (CD).