A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

Summary

The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.

Timeline

Start

2018-06-06

Primary completion

2020-11-09

Completion

2023-03-28

Outcome

Met primary endpoint

paper 46 (45%) patients in the AJM300 group and 21 (21%) patients in the placebo group had a clinical response PMID 35366419 ↗

paper odds ratio 3·30, 95% CI 1·73-6·29; p=0·00028 PMID 35366419 ↗

release “国内で実施された第Ⅲ相臨床試験（AJM300/CT3）において主要評価項目を達成しましたことをお知らせいたします。” kissei.co.jp ↗

Publications

• Matsuoka K, Watanabe M, Ohmori T, Nakajima K, Ishida T, Ishiguro Y, Kanke K, Kobayashi K, Hirai F, Watanabe K, Mizusawa H, Kishida S, Miura Y, Ohta A, Kajioka T, Hibi T; AJM300 Study Group. AJM300 (carotegrast methyl), an oral antagonist of alpha4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):648-657. doi: 10.1016/S2468-1253(22)00022-X. Epub 2022 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AJM300	Small molecule	960 mg	Oral

Indications