Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

Summary

The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).

Timeline

Start

2014-02-04

Primary completion

2018-02-27

Completion

2018-06-28

Outcome

Mixed primary results

paper CONCLUSIONS: Vedolizumab showed numerically greater efficacy compared with placebo as induction therapy, but the difference was not statistically significant. PMID 30807613 ↗

paper Vedolizumab was significantly superior to placebo as maintenance therapy in Japanese patients with UC. PMID 30807613 ↗

Publications

• Naganuma M, Watanabe K, Motoya S, Ogata H, Matsui T, Suzuki Y, Ursos L, Sakamoto S, Shikamura M, Hori T, Fernandez J, Watanabe M, Hibi T, Kanai T. Potential benefits of immunomodulator use with vedolizumab for maintenance of remission in ulcerative colitis. J Gastroenterol Hepatol. 2022 Jan;37(1):81-88. doi: 10.1111/jgh.15667. Epub 2021 Sep 7.
• Nagahori M, Watanabe K, Motoya S, Ogata H, Kanai T, Matsui T, Suzuki Y, Pinton P, Ursos L, Sakamoto S, Shikamura M, Hori T, Fernandez J, Hibi T, Watanabe M. Week 2 Symptomatic Response with Vedolizumab as a Predictive Factor in Japanese Anti-TNFalpha-Naive Patients with Ulcerative Colitis: A post hoc Analysis of a Randomized, Placebo-Controlled Phase 3 Trial. Digestion. 2021;102(5):742-752. doi: 10.1159/000512235. Epub 2021 Jan 15.
• Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10.
• Motoya S, Watanabe K, Ogata H, Kanai T, Matsui T, Suzuki Y, Shikamura M, Sugiura K, Oda K, Hori T, Araki T, Watanabe M, Hibi T. Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study. PLoS One. 2019 Feb 26;14(2):e0212989. doi: 10.1371/journal.pone.0212989. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vedolizumab	Monoclonal antibody	300 mg	Intravenous

Indications