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

Colitis, Ulcerative Clinical Trial

Official title:

A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412682
• Other study ID #: 000234
• Status: Completed
• Phase: Phase 3
• Start date: March 2, 2018
• Est. completion date: May 26, 2020

Study information

• Verified date: June 2020
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 26, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Ferring Investigator Site JPN69	Abiko-shi	Chiba
Japan	Ferring Investigator Site JPN11	Asahikawa-shi	Hokkaido
Japan	Ferring Investigator Site JPN37	Beppu-shi	Oita
Japan	Ferring Investigator Site JPN51	Chikushino	Fukuoka
Japan	Ferring Investigator Site JPN32	Fuchu-shi	Tokyo
Japan	Ferring Investigator site JPN07	Fujiidera-shi	Osaka
Japan	Ferring Investigator Site JPN50	Fukui-shi	Fukui
Japan	Ferring Investigator Site JPN31	Fukuoka-shi	Fukuoka
Japan	Ferring Investigator Site JPN64	Fukuoka-shi	Fukuoka
Japan	Ferring Investigator Site JPN36	Gifu-city	Gifu
Japan	Ferring Investigator Site JPN59	Hakodate-shi	Hokkaido
Japan	Ferring Investigator Site JPN46	Hatsukaichi-city	Hiroshima
Japan	Ferring Investigator Site JPN25	Hiroshima-shi, Hiroshima
Japan	Ferring Investigator Site JPN02	Kagoshima-shi	Kagoshima
Japan	Ferring Investigator Site JPN29	Kagoshima-shi	Kagoshima
Japan	Ferring Investigator Site JPN43	Kasama-shi	Ibaraki
Japan	Ferring Investigator Site JPN62	Kashihara-shi	Nara
Japan	Ferring Investigator Site JPN68	Kashiwa-shi	Chiba
Japan	Ferring Investigator Site JPN28	Kitakyushu-city	Fukuoka
Japan	Ferring Investigator Site JPN19	Kitakyushu-shi	Fukuoka
Japan	Ferring Investigator Site JPN23	Kitakyushu-shi	Fukuoka
Japan	Ferring Investigator Site JPN35	Kitakyushu-shi	Fukuoka
Japan	Ferring Investigator Site JPN14	Kobe-shi	Hyogo
Japan	Ferring Investigator Site JPN20	Kodaira-shi	Tokyo
Japan	Ferring Investigator Site JPN16	Kofu-shi	Yamanashi
Japan	Ferring Investigator Site JPN24	Koga-shi	Ibaraki
Japan	Ferring Investigator Site JPN38	Kurume-shi	Fukuoka
Japan	Ferring Investigator Site JPN34	Kyoto-shi	Kyoto
Japan	Ferring Investigator Site JPN15	Machida-shi	Tokyo
Japan	Ferring Investigator Site JPN08	Matsuyama-shi	Ehime
Japan	Ferring Investigator site JPN06	Meguro-ku	Tokyo
Japan	Ferring Investigator Site JPN70	Mibu	Tochigi
Japan	Ferring Investigator Site JPN58	Minato-ku	Tokyo
Japan	Ferring Investigator Site JPN71	Mitaka-shi	Tokyo
Japan	Ferring Investigator Site JPN44	Nagasaki-shi	Nagasaki
Japan	Ferring Investigator Site JPN66	Nagasaki-shi	Nagasaki
Japan	Ferring Investigator Site JPN27	Nagoya-shi	Aichi
Japan	Ferring Investigator Site JPN63	Nankoku-shi	Kochi
Japan	Ferring Investigator Site JPN55	Niigata-shi	Niigata
Japan	Ferring Investigator Site JPN13	Nishinomiya-shi	Hyogo
Japan	Ferring Investigator Site JPN40	Nishinomiya-shi	Hyogo
Japan	Ferring Investigator Site JPN01	Oita-shi	Oita
Japan	Ferring Investigator Site JPN72	Oita-shi	Oita
Japan	Ferring Investigator Site JPN65	Okayama-shi	Okayama
Japan	Ferring Investigator Site JPN10	Osaka-shi	Osaka
Japan	Ferring Investigator Site JPN26	Osaka-shi	Osaka
Japan	Ferring Investigator Site JPN30	Osaka-shi	Osaka
Japan	Ferring Investigator Site JPN18	Oume-shi	Tokyo
Japan	Ferring Investigator Site JPN03	Saitama-shi	Saitama
Japan	Ferring Investigator Site JPN09	Saitama-shi	Saitama
Japan	Ferring Investigator Site JPN60	Sakai-shi	Osaka
Japan	Ferring Investigator Site JPN49	Sakura-shi	Saitama
Japan	Ferring Investigator Site JPN61	Sapporo-shi	Hokkaido
Japan	Ferring Investigator site JPN04	Sendai-shi	Miyagi
Japan	Ferring Investigator Site JPN54	Shinagawa-Ku	Tokyo
Japan	Ferring Investigator Site JPN45	Shinjuku-Ku	Tokyo
Japan	Ferring Investigator Site JPN39	Suita-shi	Osaka
Japan	Ferring Investigator Site JPN41	Takamatsu-shi	Kagawa
Japan	Ferring Investigator Site JPN17	Takasaki-shi	Gunma
Japan	Ferring Investigator Site JPN21	Takatsuki-shi	Osaka
Japan	Ferring Investigator Site JPN42	Tokorozawa-shi	Saitama
Japan	Ferring Investigator Site JPN56	Tokorozawa-shi	Saitama
Japan	Ferring Investigator Site JPN52	Toyoake-shi	Aichi
Japan	Ferring Investigator Site JPN57	Toyonaka-shi	Osaka
Japan	Ferring Investigator Site JPN47	Toyota-shi	Aichi
Japan	Ferring Investigator Site JPN48	Tsu-shi	Mie
Japan	Ferring Investigator Site JPN22	Tsuchiura-shi	Ibaraki
Japan	Ferring Investigator Site JPN53	Urayasu-shi	Chiba
Japan	Ferring Investigator Site JPN12	Yokkaichi-shi	Mie
Japan	Ferring Investigator site JPN05	Yokohama-shi	Kanagawa
Japan	Ferring Investigator Site JPN33	Yokohama-shi	Kanagawa
Japan	Ferring Investigator Site JPN67	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score	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.	After 8 weeks
Secondary	Percentage of subjects achieving clinical remission after 8 weeks of treatment		8 weeks
Secondary	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
Secondary	Percentage of subjects achieving clinical improvement after 8 weeks of treatment		8 weeks
Secondary	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
Secondary	Percentage of subjects achieving symptom resolution after 2 weeks of treatment		2 weeks
Secondary	Percentage of subjects achieving symptom resolution after 4 weeks of treatment		4 weeks
Secondary	Percentage of subjects achieving symptom resolution after 8 weeks of treatment		8 weeks
Secondary	Percentage of subjects with endoscopic healing after 8 weeks of treatment		8 weeks
Secondary	Change from baseline in partial UCDAI score at 2 weeks		2 weeks
Secondary	Change from baseline in partial UCDAI score at 4 weeks		4 weeks
Secondary	Change from baseline in partial UCDAI score at 8 weeks		8 weeks