Vedolizumab

Generic Name
Vedolizumab
Brand Names
Entyvio
Drug Type
Biotech
Chemical Formula
-
CAS Number
943609-66-3
Unique Ingredient Identifier
9RV78Q2002
Background

Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation implicated in diseases like ulcerative colitis or Crohn's disease. α4β7 integrin facilitates the interaction between lymphocytes and gut endothelial cells through the α4β7 integrin-MAdCAM1 intera...

Indication

Vedolizumab is indicated for adult patients with moderately to severely active Ulcerative Colitis or Crohn’s disease.

Associated Conditions
Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Ulcerative Colitis
Associated Therapies
-

Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

First Posted Date
2014-01-17
Last Posted Date
2019-04-25
Lead Sponsor
Takeda
Target Recruit Count
292
Registration Number
NCT02039505

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-01-17
Last Posted Date
2019-12-09
Lead Sponsor
Takeda
Target Recruit Count
157
Registration Number
NCT02038920

Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

First Posted Date
2013-11-11
Last Posted Date
2014-07-21
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
127
Registration Number
NCT01981616
Locations
🇬🇧

ICON Development Solutions, Manchester, United Kingdom

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-10-19
Last Posted Date
2014-07-21
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
416
Registration Number
NCT01224171
Locations
🇺🇸

Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

🇺🇸

University of Kentucky Medical Center, Lexington, Kentucky, United States

🇺🇸

Gastroenterology of the Rockies, Lafayette, Colorado, United States

and more 38 locations

Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-08-06
Last Posted Date
2014-07-18
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
47
Registration Number
NCT01177228

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-11-14
Last Posted Date
2022-05-24
Lead Sponsor
Takeda
Target Recruit Count
2243
Registration Number
NCT00790933

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-11-02
Last Posted Date
2014-07-18
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
895
Registration Number
NCT00783718
Locations
🇺🇸

Gastroenterology Associates of Central Georgia, Macon, Georgia, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Boston Medical Center, Boston, Massachusetts, United States

and more 101 locations

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-11-02
Last Posted Date
2014-07-21
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
1116
Registration Number
NCT00783692
Locations
🇺🇸

Puget Sound Medical Research, Edmonds, Washington, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

🇺🇸

University of Pittsburgh Medical Center - Cancer Centers, Pittsburgh, Pennsylvania, United States

and more 110 locations

Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-02-21
Last Posted Date
2014-07-18
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
72
Registration Number
NCT00619489
Locations
🇨🇦

London Health Sciences Centre, London, Ontario, Canada

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