To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

March 2, 2018

Primary Completion Date

May 11, 2020

Study Completion Date

May 26, 2020

Conditions
Colitis, Ulcerative
Interventions
DRUG

Budesonide (6 mg)

Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

DRUG

Budesonide (9 mg)

Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

DRUG

Mesalazine (3,600 mg)

Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.

Trial Locations (72)

Unknown

Ferring Investigator Site JPN27, Nagoya

Ferring Investigator Site JPN52, Toyoake-shi

Ferring Investigator Site JPN47, Toyota-shi

Ferring Investigator Site JPN69, Abiko-shi

Ferring Investigator Site JPN68, Kashiwa-shi

Ferring Investigator Site JPN53, Urayasu-shi

Ferring Investigator Site JPN08, Matsuyama

Ferring Investigator Site JPN50, Fukui-shi

Ferring Investigator Site JPN51, Chikushino-shi

Ferring Investigator Site JPN31, Fukuoka

Ferring Investigator Site JPN64, Fukuoka

Ferring Investigator Site JPN28, Kitakyushu

Ferring Investigator Site JPN19, Kitakyushu-shi

Ferring Investigator Site JPN23, Kitakyushu-shi

Ferring Investigator Site JPN35, Kitakyushu-shi

Ferring Investigator Site JPN38, Kurume-shi

Ferring Investigator Site JPN36, Gifu

Ferring Investigator Site JPN17, Takasaki-shi

Ferring Investigator Site JPN46, Hatsukaichi

Ferring Investigator Site JPN11, Asahikawa-shi

Ferring Investigator Site JPN59, Hakodate-shi

Ferring Investigator Site JPN61, Sapporo

Ferring Investigator Site JPN14, Kobe

Ferring Investigator Site JPN13, Nishinomiya-shi

Ferring Investigator Site JPN40, Nishinomiya-shi

Ferring Investigator Site JPN43, Kasama-shi

Ferring Investigator Site JPN24, Koga-shi

Ferring Investigator Site JPN22, Tsuchiura-shi

Ferring Investigator Site JPN41, Takamatsu

Ferring Investigator Site JPN02, Kagoshima

Ferring Investigator Site JPN29, Kagoshima

Ferring Investigator site JPN05, Yokohama

Ferring Investigator Site JPN33, Yokohama

Ferring Investigator Site JPN67, Yokohama

Ferring Investigator Site JPN63, Nankoku-shi

Ferring Investigator Site JPN34, Kyoto

Ferring Investigator Site JPN48, Tsu

Ferring Investigator Site JPN12, Yokkaichi-shi

Ferring Investigator site JPN04, Sendai

Ferring Investigator Site JPN44, Nagasaki

Ferring Investigator Site JPN66, Nagasaki

Ferring Investigator Site JPN62, Kashihara-shi

Ferring Investigator Site JPN55, Niigata

Ferring Investigator Site JPN37, Beppu-shi

Ferring Investigator Site JPN01, Ōita

Ferring Investigator Site JPN72, Ōita

Ferring Investigator Site JPN65, Okayama

Ferring Investigator site JPN07, Fujiidera-shi

Ferring Investigator Site JPN10, Osaka

Ferring Investigator Site JPN26, Osaka

Ferring Investigator Site JPN30, Osaka

Ferring Investigator Site JPN60, Sakai-shi

Ferring Investigator Site JPN39, Suita-shi

Ferring Investigator Site JPN21, Takatsuki-shi

Ferring Investigator Site JPN57, Toyonaka-shi

Ferring Investigator Site JPN03, Saitama-shi

Ferring Investigator Site JPN09, Saitama-shi

Ferring Investigator Site JPN49, Sakura-shi

Ferring Investigator Site JPN42, Tokorozawa-shi

Ferring Investigator Site JPN56, Tokorozawa-shi

Ferring Investigator Site JPN70, Mibu

Ferring Investigator Site JPN32, Fuchū-shi

Ferring Investigator Site JPN20, Kodaira-shi

Ferring Investigator Site JPN15, Machida-shi

Ferring Investigator site JPN06, Meguro-ku

Ferring Investigator Site JPN58, Minato-ku

Ferring Investigator Site JPN71, Mitaka-shi

Ferring Investigator Site JPN18, Oume-shi

Ferring Investigator Site JPN54, Shinagawa-Ku

Ferring Investigator Site JPN45, Shinjuku-Ku

Ferring Investigator Site JPN16, Kofu

Ferring Investigator Site JPN25, Hiroshima-shi, Hiroshima

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY