Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Phase 3 Completed 644 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

Timeline

Start: 2016-01-04
Primary completion: 2019-05-06
Completion: 2019-08-06

Outcome

Met primary endpoint

registry analysis (superiority test); Maintenance Phase: Induction IV + Placebo vs Maintenance Phase: Induction IV + Vedolizumab 108 mg SC; p = 0.008 NCT02611817 ↗

release “meeting the study’s primary endpoint.” takeda.com ↗

Publications

D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV Jr, Sandborn WJ, Dornic Q, Lindner D, Kisfalvi K, Marins EG, Vermeire S. Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vedolizumab	Monoclonal antibody	108 mg	Subcutaneous
Subject	Vedolizumab	Monoclonal antibody	300 mg	Subcutaneous