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 interaction, leading to the mobilization of lymphocytes and thus contributing to gastrointestinal inflammation. Integrins implicated in cell migration into the intestinal tract included α2β2, α4β1, and α4β7; however, the selective activity of vedolizumab against α4β7 integrin has been thought to contribute to its more favorable safety profile compared to its predecessor natalizumab, the first integrin receptor antagonist approved by the FDA. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.

Vedolizumab was developed by Takeda and approved by the FDA under the brand name ENTYVIO for the maintenance therapy of moderately to severely active Ulcerative Colitis and Crohn’s Disease in April and September 2023, respectively.

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: -

Clinical Trials

Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT

Phase 1

Completed

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Interventions: Drug: Vedolizumab

First Posted Date: 2016-04-05

Last Posted Date: 2019-08-26

Lead Sponsor: Takeda

Target Recruit Count: 24

Registration Number: NCT02728895

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
OSU - James Comprehensive Cancer Center, Columbus, Ohio, United States

and more 2 locations

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma

Phase 1

Terminated

Conditions: Melanoma

Interventions: Drug: TAK-580
Drug: TAK-202
Drug: vedolizumab
Drug: nivolumab
Drug: ipilimumab

First Posted Date: 2016-03-30

Last Posted Date: 2024-03-05

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 22

Registration Number: NCT02723006

Locations: 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

and more 11 locations

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

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Vedolizumab

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: IBD

Interventions: Drug: Infliximab
Drug: Vedolizumab

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

Completed

Conditions: Colitis, Ulcerative
Crohn's Disease

Interventions: Drug: Vedolizumab
Biological: Other Biological Agent

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

Completed

Conditions: Ulcerative Colitis and Crohn's Disease

Interventions: Other: Other Biologic Agents
Drug: Vedolizumab

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: Crohn Disease

Interventions: Drug: vedolizumab

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: Crohn's Disease

Interventions: Drug: Vedolizumab
Drug: Placebo

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: Colitis, Ulcerative
Crohn's Disease

Interventions: Drug: Vedolizumab

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

Phase 3

Completed

Conditions: Colitis, Ulcerative

Interventions: Drug: Vedolizumab
Drug: Adalimumab
Drug: Vedolizumab placebo
Drug: Adalimumab placebo

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

Drug Development Updates

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