Clinical trial NCT03412682: To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Ulcerative colitis
FE999315
Mesalazine
Colitis
Colitis, Ulcerative
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-01-26
Enrollment: 274
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
timeFrame: After 8 weeks
Secondary outcomes:
measure: Percentage of subjects achieving clinical remission after 8 weeks of treatment
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Percentage of subjects achieving clinical improvement after 8 weeks of treatment
timeFrame: 8 weeks
measure: Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1
timeFrame: 8 weeks
measure: Percentage of subjects achieving symptom resolution after 2 weeks of treatment
timeFrame: 2 weeks
measure: Percentage of subjects achieving symptom resolution after 4 weeks of treatment
timeFrame: 4 weeks
measure: Percentage of subjects achieving symptom resolution after 8 weeks of treatment
timeFrame: 8 weeks
measure: Percentage of subjects with endoscopic healing after 8 weeks of treatment
timeFrame: 8 weeks
measure: Change from baseline in partial UCDAI score at 2 weeks
timeFrame: 2 weeks
measure: Change from baseline in partial UCDAI score at 4 weeks
timeFrame: 4 weeks
measure: Change from baseline in partial UCDAI score at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Ferring Investigator Site JPN27
state: Aichi
city: Toyoake-shi
country: Japan
facility: Ferring Investigator Site JPN52
state: Aichi
city: Toyota-shi
country: Japan
facility: Ferring Investigator Site JPN47
state: Aichi
city: Abiko-shi
country: Japan
facility: Ferring Investigator Site JPN69
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Ferring Investigator Site JPN68
state: Chiba
city: Urayasu-shi
country: Japan
facility: Ferring Investigator Site JPN53
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Ferring Investigator Site JPN08
state: Ehime
city: Fukui-shi
country: Japan
facility: Ferring Investigator Site JPN50
state: Fukui
city: Chikushino
country: Japan
facility: Ferring Investigator Site JPN51
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Ferring Investigator Site JPN31
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Ferring Investigator Site JPN64
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Ferring Investigator Site JPN28
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Ferring Investigator Site JPN19
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Ferring Investigator Site JPN23
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Ferring Investigator Site JPN35
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Ferring Investigator Site JPN38
state: Fukuoka
city: Gifu-city
country: Japan
facility: Ferring Investigator Site JPN36
state: Gifu
city: Takasaki-shi
country: Japan
facility: Ferring Investigator Site JPN17
state: Gunma
city: Hatsukaichi-city
country: Japan
facility: Ferring Investigator Site JPN46
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Ferring Investigator Site JPN11
state: Hokkaido
city: Hakodate-shi
country: Japan
facility: Ferring Investigator Site JPN59
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Ferring Investigator Site JPN61
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Ferring Investigator Site JPN14
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Ferring Investigator Site JPN13
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Ferring Investigator Site JPN40
state: Hyogo
city: Kasama-shi
country: Japan
facility: Ferring Investigator Site JPN43
state: Ibaraki
city: Koga-shi
country: Japan
facility: Ferring Investigator Site JPN24
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Ferring Investigator Site JPN22
state: Ibaraki
city: Takamatsu-shi
country: Japan
facility: Ferring Investigator Site JPN41
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Ferring Investigator Site JPN02
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Ferring Investigator Site JPN29
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Ferring Investigator site JPN05
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Ferring Investigator Site JPN33
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Ferring Investigator Site JPN67
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Ferring Investigator Site JPN63
state: Kochi
city: Kyoto-shi
country: Japan
facility: Ferring Investigator Site JPN34
state: Kyoto
city: Tsu-shi
country: Japan
facility: Ferring Investigator Site JPN48
state: Mie
city: Yokkaichi-shi
country: Japan
facility: Ferring Investigator Site JPN12
state: Mie
city: Sendai-shi
country: Japan
facility: Ferring Investigator site JPN04
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Ferring Investigator Site JPN44
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Ferring Investigator Site JPN66
state: Nagasaki
city: Kashihara-shi
country: Japan
facility: Ferring Investigator Site JPN62
state: Nara
city: Niigata-shi
country: Japan
facility: Ferring Investigator Site JPN55
state: Niigata
city: Beppu-shi
country: Japan
facility: Ferring Investigator Site JPN37
state: Oita
city: Oita-shi
country: Japan
facility: Ferring Investigator Site JPN01
state: Oita
city: Oita-shi
country: Japan
facility: Ferring Investigator Site JPN72
state: Oita
city: Okayama-shi
country: Japan
facility: Ferring Investigator Site JPN65
state: Okayama
city: Fujiidera-shi
country: Japan
facility: Ferring Investigator site JPN07
state: Osaka
city: Osaka-shi
country: Japan
facility: Ferring Investigator Site JPN10
state: Osaka
city: Osaka-shi
country: Japan
facility: Ferring Investigator Site JPN26
state: Osaka
city: Osaka-shi
country: Japan
facility: Ferring Investigator Site JPN30
state: Osaka
city: Sakai-shi
country: Japan
facility: Ferring Investigator Site JPN60
state: Osaka
city: Suita-shi
country: Japan
facility: Ferring Investigator Site JPN39
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Ferring Investigator Site JPN21
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Ferring Investigator Site JPN57
state: Osaka
city: Saitama-shi
country: Japan
facility: Ferring Investigator Site JPN03
state: Saitama
city: Saitama-shi
country: Japan
facility: Ferring Investigator Site JPN09
state: Saitama
city: Sakura-shi
country: Japan
facility: Ferring Investigator Site JPN49
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: Ferring Investigator Site JPN42
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: Ferring Investigator Site JPN56
state: Saitama
city: Mibu
country: Japan
facility: Ferring Investigator Site JPN70
state: Tochigi
city: Fuchū-shi
country: Japan
facility: Ferring Investigator Site JPN32
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Ferring Investigator Site JPN20
state: Tokyo
city: Machida-shi
country: Japan
facility: Ferring Investigator Site JPN15
state: Tokyo
city: Meguro-ku
country: Japan
facility: Ferring Investigator site JPN06
state: Tokyo
city: Minato-ku
country: Japan
facility: Ferring Investigator Site JPN58
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Ferring Investigator Site JPN71
state: Tokyo
city: Oume-shi
country: Japan
facility: Ferring Investigator Site JPN18
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Ferring Investigator Site JPN54
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Ferring Investigator Site JPN45
state: Tokyo
city: Kofu-shi
country: Japan
facility: Ferring Investigator Site JPN16
state: Yamanashi
city: Hiroshima-shi, Hiroshima
country: Japan
facility: Ferring Investigator Site JPN25
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: