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Vedolizumab IV

DRUG12 trials

Sponsors

Takeda, Eli Lilly and Company

Conditions

Colitis, UlcerativeCrohn DiseaseCrohn's DiseaseCrohn's Disease (CD)HealthyModerately to Severely Active Ulcerative ColitisUlcerative Colitis

Phase 1

Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
CompletedNCT02163421
TakedaHealthy
Start: 2014-06-30End: 2015-01-31Updated: 2017-02-01

Phase 3

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
Active, not recruitingNCT03221036
TakedaModerately to Severely Active Ulcerative Colitis
Start: 2017-08-03End: 2028-01-30Updated: 2026-05-22
Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
CompletedNCT03234907
TakedaCrohn's Disease
Start: 2017-08-03End: 2020-08-14Updated: 2023-03-01
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
WithdrawnNCT04469062
Eli Lilly and CompanyUlcerative Colitis
Start: 2021-04-20End: 2024-06-05Updated: 2021-05-06
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
RecruitingNCT04779320
TakedaCrohn's Disease (CD)
Start: 2022-02-10End: 2027-09-13Target: 120Updated: 2026-05-05
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
RecruitingNCT05442567
TakedaCrohn's Disease, Ulcerative Colitis
Start: 2023-05-16End: 2033-02-07Target: 240Updated: 2026-05-07
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
RecruitingNCT05837897
TakedaCrohn's Disease
Start: 2023-06-16End: 2031-05-30Target: 408Updated: 2025-11-05
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
RecruitingNCT06100289
TakedaCrohn's Disease, Ulcerative Colitis
Start: 2025-01-22End: 2028-05-16Target: 70Updated: 2026-08-03

Phase 4

Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
CompletedNCT03029143
TakedaColitis, Ulcerative
Start: 2017-03-29End: 2020-10-16Updated: 2023-07-28
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
CompletedNCT04804540
TakedaCrohn Disease, Ulcerative Colitis
Start: 2021-12-08End: 2024-02-02Updated: 2025-02-12
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
RecruitingNCT06581328
TakedaCrohn's Disease, Ulcerative Colitis
Start: 2025-03-27End: 2028-06-01Target: 200Updated: 2026-09-15

Unknown Phase

Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
NCT06856135
TakedaCrohn's Disease, Ulcerative Colitis
Updated: 2026-02-27

Related Papers

Efficacy and safety of intravenous vedolizumab treatment in Chinese patients with moderate-to-severe Crohn's disease.
2025-04-122 citations
P1048 Vedolizumab in Indian patients with Inflammatory Bowel Disease: Final results from a prospective, multicentre, open-label, phase 4 study
Journal of Crohn s and Colitis2025-01-01
The relationship among vedolizumab drug concentrations, biomarkers of inflammation, and clinical outcomes in a Canadian real-world study
Journal of the Canadian Association of Gastroenterology2024-03-247 citations
P628 Vedolizumab in Indian patients with Inflammatory Bowel Disease: Interim results from a prospective, multicentre, open-label, phase 4 study
Journal of Crohn s and Colitis2024-01-011 citations
ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse
Clinical Gastroenterology and Hepatology2023-11-1023 citations
Pharmacokinetic-Pharmacodynamic Model of Vedolizumab for Targeting Endoscopic Remission in Patients With Crohn Disease: Posthoc Analysis of the LOVE-CD Study
Inflammatory Bowel Diseases2021-06-1724 citations
Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis
Journal of Crohn s and Colitis2018-09-2832 citations