CLINICAL TRIALS PROFILE FOR VEDOLIZUMAB

All Clinical Trials for vedolizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00619489 ↗	Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-12-01	This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
NCT00783692 ↗	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2008-12-01	The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
NCT00783718 ↗	Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2009-01-01	The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
NCT00790933 ↗	An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2009-05-22	The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
NCT00790933 ↗	An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease	Completed	Takeda	Phase 3	2009-05-22	The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
NCT01177228 ↗	Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-05-01	The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).
NCT01224171 ↗	Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease	Completed	Millennium Pharmaceuticals, Inc.	Phase 3	2010-11-01	This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Clinical Trial Conditions for vedolizumab

Condition Name

Condition Name for vedolizumab
Intervention	Trials
Ulcerative Colitis	28
Crohn's Disease	22
Crohn Disease	17
Colitis, Ulcerative	14

Condition MeSH

Condition MeSH for vedolizumab
Intervention	Trials
Colitis, Ulcerative	46
Colitis	43
Ulcer	41
Crohn Disease	39

Clinical Trial Locations for vedolizumab

Trials by Country

Trials by Country for vedolizumab
Location	Trials
United States	496
Japan	127
Canada	65
Germany	48
France	38

Trials by US State

Trials by US State for vedolizumab
Location	Trials
Texas	24
New York	24
Florida	20
Georgia	19
California	19

Clinical Trial Progress for vedolizumab

Clinical Trial Phase

Clinical Trial Phase for vedolizumab
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	24
Phase 2	18

Clinical Trial Status

Clinical Trial Status for vedolizumab
Clinical Trial Phase	Trials
Completed	32
Recruiting	18
Not yet recruiting	14

Clinical Trial Sponsors for vedolizumab

Sponsor Name

Sponsor Name for vedolizumab
Sponsor	Trials
Takeda	45
Millennium Pharmaceuticals, Inc.	10
Takeda Development Center Americas, Inc.	2

Sponsor Type

Sponsor Type for vedolizumab
Sponsor	Trials
Industry	65
Other	60
NIH	2