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Vedolizumab SC

DRUG9 trials

Sponsors

Takeda

Conditions

Colitis, UlcerativeCrohn's DiseaseHealthyHealthy VolunteersUlcerative 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
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
CompletedNCT03948581
TakedaHealthy Volunteers
Start: 2018-02-21End: 2018-09-21Updated: 2022-07-29
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
CompletedNCT03949621
TakedaHealthy Volunteers
Start: 2018-02-06End: 2018-08-13Updated: 2019-11-13
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
CompletedNCT03961295
TakedaHealthy Volunteers
Start: 2018-02-22End: 2018-08-28Updated: 2019-11-13
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
CompletedNCT03961308
TakedaHealthy Volunteers
Start: 2018-03-12End: 2018-11-21Updated: 2019-11-14

Phase 3

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
CompletedNCT02620046
TakedaColitis, Ulcerative, Crohn's Disease
Start: 2016-04-15End: 2024-06-12Updated: 2025-04-03
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
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
RecruitingNCT06405087
TakedaCrohn's Disease, Ulcerative Colitis
Start: 2025-10-27End: 2030-08-12Target: 70Updated: 2026-06-22

Phase 4

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

Related Papers

DOP090 Persistence and treatment patterns of vedolizumab subcutaneous maintenance therapy in patients with Inflammatory Bowel Disease: data from a Canadian cohort
Journal of Crohn s and Colitis2026-01-01
P0755 Long-term safety of subcutaneous vedolizumab in Ulcerative Colitis and Crohn’s disease: Findings from the VISIBLE OLE study
Journal of Crohn s and Colitis2025-01-01
P0867 Persistence of treatment effect in patients with Ulcerative Colitis and Crohn’s disease: Long-term results from the VISIBLE OLE study
Journal of Crohn s and Colitis2025-01-01
P0841 Hospitalisation and surgery rates in patients with Ulcerative Colitis and Crohn’s disease treated with subcutaneous vedolizumab: Long-term findings from the VISIBLE OLE study
Journal of Crohn s and Colitis2025-01-01
Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: <i>Post Hoc</i> Analyses of Clinical Trial Data
Journal of Crohn s and Colitis2023-07-2610 citations
S0653 Long-Term Treatment With Vedolizumab SC in Ulcerative Colitis: Interim Results From VISIBLE OLE
The American Journal of Gastroenterology2020-10-015 citations
Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Intestinal Research2020-08-1817 citations
P510 Dose escalation of subcutaneous vedolizumab in patients with ulcerative colitis: A post hoc analysis of the VISIBLE trial data
Journal of Crohn s and Colitis2020-01-014 citations
634 Transitioning From Vedolizumab IV to Vedolizumab SC in Patients With Ulcerative Colitis: Results From the VISIBLE Program
The American Journal of Gastroenterology2019-10-015 citations
P490 A vedolizumab population pharmacokinetic model including intravenous and subcutaneous formulations for patients with ulcerative colitis
Journal of Crohn s and Colitis2019-01-2512 citations