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

Phase 3

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Budesonide (6 mg); Drug: Mesalazine (3,600 mg); Drug: Budesonide (9 mg)

• Registration Number: NCT03412682
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-26
• Study Start: 2018-03-02
• Primary Completion: 2020-05-11
• Study Completion: 2020-05-26
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
• Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
• Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
• Male patients must agree to use medically approved contraception throughout the trial period.

Exclusion Criteria

• Patients with limited distal proctitis.
• Patients with infectious colitis.
• Patients with history of colectomy.
• Patients with severe diseases in other organs and systems.
• Evidence or history of toxic megacolon.
• Women who wish to become pregnant during the trial period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide (6 mg)	Budesonide (6 mg)	-
Mesalazine (3,600 mg)	Mesalazine (3,600 mg)	-
Budesonide (9 mg)	Budesonide (9 mg)	-

Primary Outcome Measures

Name	Time	Method
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score	After 8 weeks	UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving clinical remission after 8 weeks of treatment	8 weeks
Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment	8 weeks
Percentage of subjects achieving clinical improvement after 8 weeks of treatment	8 weeks
Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1	8 weeks
Percentage of subjects achieving symptom resolution after 2 weeks of treatment	2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment	4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment	8 weeks
Percentage of subjects with endoscopic healing after 8 weeks of treatment	8 weeks
Change from baseline in partial UCDAI score at 2 weeks	2 weeks
Change from baseline in partial UCDAI score at 4 weeks	4 weeks
Change from baseline in partial UCDAI score at 8 weeks	8 weeks

Trial Locations

Locations (72)

Ferring Investigator Site JPN59; 🇯🇵 Hakodate-shi, Hokkaido, Japan

Ferring Investigator Site JPN11; 🇯🇵 Asahikawa-shi, Hokkaido, Japan

Ferring Investigator Site JPN27; 🇯🇵 Nagoya-shi, Aichi, Japan

Ferring Investigator Site JPN19; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator Site JPN29; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

Ferring Investigator Site JPN51; 🇯🇵 Chikushino, Fukuoka, Japan

Ferring Investigator Site JPN53; 🇯🇵 Urayasu-shi, Chiba, Japan

Ferring Investigator Site JPN28; 🇯🇵 Kitakyushu-city, Fukuoka, Japan

Ferring Investigator Site JPN58; 🇯🇵 Minato-ku, Tokyo, Japan

Ferring Investigator Site JPN24; 🇯🇵 Koga-shi, Ibaraki, Japan

Ferring Investigator Site JPN65; 🇯🇵 Okayama-shi, Okayama, Japan

Ferring Investigator Site JPN47; 🇯🇵 Toyota-shi, Aichi, Japan

Ferring Investigator Site JPN64; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Ferring Investigator Site JPN30; 🇯🇵 Osaka-shi, Osaka, Japan

Ferring Investigator Site JPN43; 🇯🇵 Kasama-shi, Ibaraki, Japan

Ferring Investigator Site JPN62; 🇯🇵 Kashihara-shi, Nara, Japan

Ferring Investigator Site JPN55; 🇯🇵 Niigata-shi, Niigata, Japan

Ferring Investigator Site JPN16; 🇯🇵 Kofu-shi, Yamanashi, Japan

Ferring Investigator Site JPN66; 🇯🇵 Nagasaki-shi, Nagasaki, Japan

Ferring Investigator Site JPN37; 🇯🇵 Beppu-shi, Oita, Japan

Ferring Investigator Site JPN49; 🇯🇵 Sakura-shi, Saitama, Japan

Ferring Investigator Site JPN32; 🇯🇵 Fuchū-shi, Tokyo, Japan

Ferring Investigator Site JPN54; 🇯🇵 Shinagawa-Ku, Tokyo, Japan

Ferring Investigator Site JPN18; 🇯🇵 Oume-shi, Tokyo, Japan

Ferring Investigator site JPN06; 🇯🇵 Meguro-ku, Tokyo, Japan

Ferring Investigator Site JPN15; 🇯🇵 Machida-shi, Tokyo, Japan

Ferring Investigator Site JPN68; 🇯🇵 Kashiwa-shi, Chiba, Japan

Ferring Investigator Site JPN40; 🇯🇵 Nishinomiya-shi, Hyogo, Japan

Ferring Investigator Site JPN31; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Ferring Investigator Site JPN35; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator Site JPN38; 🇯🇵 Kurume-shi, Fukuoka, Japan

Ferring Investigator Site JPN17; 🇯🇵 Takasaki-shi, Gunma, Japan

Ferring Investigator Site JPN22; 🇯🇵 Tsuchiura-shi, Ibaraki, Japan

Ferring Investigator site JPN05; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Ferring Investigator Site JPN41; 🇯🇵 Takamatsu-shi, Kagawa, Japan

Ferring Investigator Site JPN02; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

Ferring Investigator Site JPN33; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Ferring Investigator Site JPN63; 🇯🇵 Nankoku-shi, Kochi, Japan

Ferring Investigator Site JPN01; 🇯🇵 Oita-shi, Oita, Japan

Ferring Investigator Site JPN72; 🇯🇵 Oita-shi, Oita, Japan

Ferring Investigator site JPN07; 🇯🇵 Fujiidera-shi, Osaka, Japan

Ferring Investigator Site JPN21; 🇯🇵 Takatsuki-shi, Osaka, Japan

Ferring Investigator Site JPN39; 🇯🇵 Suita-shi, Osaka, Japan

Ferring Investigator Site JPN03; 🇯🇵 Saitama-shi, Saitama, Japan

Ferring Investigator Site JPN42; 🇯🇵 Tokorozawa-shi, Saitama, Japan

Ferring Investigator Site JPN70; 🇯🇵 Mibu, Tochigi, Japan

Ferring Investigator Site JPN52; 🇯🇵 Toyoake-shi, Aichi, Japan

Ferring Investigator Site JPN69; 🇯🇵 Abiko-shi, Chiba, Japan

Ferring Investigator Site JPN50; 🇯🇵 Fukui-shi, Fukui, Japan

Ferring Investigator Site JPN08; 🇯🇵 Matsuyama-shi, Ehime, Japan

Ferring Investigator Site JPN23; 🇯🇵 Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator Site JPN13; 🇯🇵 Nishinomiya-shi, Hyogo, Japan

Ferring Investigator Site JPN36; 🇯🇵 Gifu-city, Gifu, Japan

Ferring Investigator Site JPN46; 🇯🇵 Hatsukaichi-city, Hiroshima, Japan

Ferring Investigator Site JPN61; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Ferring Investigator Site JPN14; 🇯🇵 Kobe-shi, Hyogo, Japan

Ferring Investigator Site JPN67; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Ferring Investigator Site JPN48; 🇯🇵 Tsu-shi, Mie, Japan

Ferring Investigator Site JPN12; 🇯🇵 Yokkaichi-shi, Mie, Japan

Ferring Investigator Site JPN44; 🇯🇵 Nagasaki-shi, Nagasaki, Japan

Ferring Investigator site JPN04; 🇯🇵 Sendai-shi, Miyagi, Japan

Ferring Investigator Site JPN10; 🇯🇵 Osaka-shi, Osaka, Japan

Ferring Investigator Site JPN56; 🇯🇵 Tokorozawa-shi, Saitama, Japan

Ferring Investigator Site JPN26; 🇯🇵 Osaka-shi, Osaka, Japan

Ferring Investigator Site JPN57; 🇯🇵 Toyonaka-shi, Osaka, Japan

Ferring Investigator Site JPN60; 🇯🇵 Sakai-shi, Osaka, Japan

Ferring Investigator Site JPN09; 🇯🇵 Saitama-shi, Saitama, Japan

Ferring Investigator Site JPN20; 🇯🇵 Kodaira-shi, Tokyo, Japan

Ferring Investigator Site JPN45; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Ferring Investigator Site JPN25; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

Ferring Investigator Site JPN34; 🇯🇵 Kyoto-shi, Kyoto, Japan

Ferring Investigator Site JPN71; 🇯🇵 Mitaka-shi, Tokyo, Japan