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
-

Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.

Completed
Conditions
Interventions
First Posted Date
2016-03-18
Last Posted Date
2019-02-28
Lead Sponsor
Parc de Salut Mar
Target Recruit Count
24
Registration Number
NCT02712866
Locations
🇪🇸

Hospital del Mar, Barcelona, Spain

Clinical and Molecular Phenotyping in IBD

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2016-02-29
Last Posted Date
2022-07-01
Lead Sponsor
University Hospital Schleswig-Holstein
Target Recruit Count
90
Registration Number
NCT02694588
Locations
🇩🇪

Medical Department I, University Hospital Schleswig-Holstein, Kiel, Germany

OTIS Vedolizumab Pregnancy Exposure Registry

First Posted Date
2016-02-09
Last Posted Date
2024-10-07
Lead Sponsor
Takeda
Target Recruit Count
303
Registration Number
NCT02678052

Entyvio (Vedolizumab) Long Term Safety Study

First Posted Date
2016-02-04
Last Posted Date
2024-10-31
Lead Sponsor
Takeda
Target Recruit Count
5302
Registration Number
NCT02674308
Locations
🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

University of South Alabama, Mobile, Alabama, United States

🇺🇸

University of Arizona Medical Center, Tucson, Arizona, United States

and more 281 locations

A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-01-06
Last Posted Date
2023-06-23
Lead Sponsor
Geert D'Haens
Target Recruit Count
260
Registration Number
NCT02646683
Locations
🇧🇪

Imeldahospital, Bonheiden, Belgium

🇧🇪

ULB Erasme, Brussels, Belgium

🇳🇱

Academisch Medisch Centrum, Amsterdam, Netherlands

and more 20 locations

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-12-15
Last Posted Date
2019-11-19
Lead Sponsor
Takeda
Target Recruit Count
34
Registration Number
NCT02630966
Locations
🇫🇷

Hopital de Brabois, Vandoeuvre les Nancy, France

🇫🇷

Hopital l'Archet II, Nice Cedex 3, France

🇳🇱

Academic Medical Center, Amsterdam, Netherlands

and more 15 locations

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-09-24
Last Posted Date
2021-01-08
Lead Sponsor
Takeda
Target Recruit Count
11
Registration Number
NCT02559713
Locations
🇺🇸

Atlantic Health System, Morristown, New Jersey, United States

🇺🇸

Feinberg School of Medicine Northwestern University, Chicago, Illinois, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

and more 4 locations

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

First Posted Date
2015-07-14
Last Posted Date
2020-01-28
Lead Sponsor
Takeda
Target Recruit Count
771
Registration Number
NCT02497469
Locations
🇺🇸

Chevy Chase Clinical Research, Chevy Chase, Maryland, United States

🇺🇸

Texas Digestive Disease Consultants - Dallas, Dallas, Texas, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 326 locations

Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-04-23
Last Posted Date
2018-09-14
Lead Sponsor
Takeda
Target Recruit Count
101
Registration Number
NCT02425111

Corticosteroids With Vedolizumab in Crohn's Disease

First Posted Date
2014-12-24
Last Posted Date
2019-04-26
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
1
Registration Number
NCT02324699
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

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