Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

NCT02038920 ↗

Phase 3 Completed 157 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.

Timeline

Start: 2014-01-28
Primary completion: 2019-01-25
Completion: 2019-05-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Induction Phase: Vedolizumab, 300 mg vs Induction Phase: Placebo; p = 0.1448; Odds Ratio (OR) 1.80 (95% CI 0.816 to 3.958) NCT02038920 ↗

Publications

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.

Drugs

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