活動性潰瘍性大腸炎患者におけるAJM300の安全性および有効性を評価する研究

基本情報

NCT ID: NCT03531892
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 198
治験依頼者名: Eisai Inc.

概要

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.

対象疾患

Colitis, Ulcerative

介入

AJM300(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

Ea(INDUSTRY)

キッセイ薬品工業株式会社(INDUSTRY)

実施施設 (50)

AJM300/CT3 trial site 4

Sapporo, Hokkaido, Japan

AJM300/CT3 trial site 64

Nishinomiya, Hyōgo, Japan

AJM300/CT3 trial site 78

Sendai, Miyagi, Japan

AJM300/CT3 trial site 33

Toyohashi, Aichi-ken, Japan

AJM300/CT3 trial site 14

Sagamihara, Kanagawa, Japan

AJM300/CT3 trial site 69

Fukuoka, Japan

AJM300/CT3 trial site 20

Saga, Japan

AJM300/CT3 trial site 13

Yokohama, Kanagawa, Japan

AJM300/CT3 trial site 42

Toyota, Aichi-ken, Japan

AJM300/CT3 trial site 55

Isesaki, Gunma, Japan

AJM300/CT3 trial site 62

Kyoto, Japan

AJM300/CT3 trial site 25

Saga, Japan

AJM300/CT3 trial site 8

Shūnan, Yamaguchi, Japan

AJM300/CT3 trial site 77

Higashiosaka, Osaka, Japan

AJM300/CT3 trial site 24

Tikushino, Fukuoka, Japan

AJM300/CT3 trial site 5

Ageo, Saitama, Japan

AJM300/CT3 trial site 48

Nagasaki, Japan

AJM300/CT3 trial site 37

Ōita, Japan

AJM300/CT3 trial site 49

Hirosaki, Aomori, Japan

AJM300/CT3 trial site 28

Hiroshima, Japan

AJM300/CT3 trial site 3

Sapporo, Hokkaido, Japan

AJM300/CT3 trial site 74

Hiroshima, Japan

AJM300/CT3 trial site 68

Bunkyo, Tokyo, Japan

AJM300/CT3 trial site 81

Matsuyama, Ehime, Japan

AJM300/CT3 trial site 71

Utsunomiya, Tochigi, Japan

AJM300/CT3 trial site 43

Fukuoka, Japan

AJM300/CT3 trial site 47

Tsu, Mie-ken, Japan

AJM300/CT3 trial site 46

Yokkaichi, Mie-ken, Japan

AJM300/CT3 trial site 23

Kofu, Yamanashi, Japan

AJM300/CT3 trial site 22

Nagaoka, Niigata, Japan

AJM300/CT3 trial site 53

Kurume, Fukuoka, Japan

AJM300/CT3 trial site 54

Urayasu, Chiba, Japan

AJM300/CT3 trial site 10

Takatsuki, Osaka, Japan

AJM300/CT3 trial site 57

Nagoya, Aichi-ken, Japan

AJM300/CT3 trial site 15

Kurashiki, Okayama-ken, Japan

AJM300/CT3 trial site 44

Chiba, Japan

AJM300/CT3 trial site 59

Chiyoda City, Tokyo, Japan

AJM300/CT3 trial site 58

Fukuoka, Japan

AJM300/CT3 trial site 6

Yokohama, Kanagawa, Japan

AJM300/CT3 trial site 70

Kurashiki, Okayama-ken, Japan

AJM300/CT3 trial site 26

Asahikawa, Hokkaido, Japan

AJM300/CT3 trial site 41

Nagoya, Aichi-ken, Japan

AJM300/CT3 trial site 29

Shimotsuga, Tochigi, Japan

AJM300/CT3 trial site 12

Kamakura, Kanagawa, Japan

AJM300/CT3 trial site 31

Hachiōji, Tokyo, Japan

AJM300/CT3 trial site 30

Chūō, Tokyo, Japan

AJM300/CT3 trial site 79

Akashi, Hyōgo, Japan

AJM300/CT3 trial site 17

Hamamatsu, Shizuoka, Japan

AJM300/CT3 trial site 7

Kyoto, Japan

AJM300/CT3 trial site 72

Tokorozawa, Saitama, Japan