Back to resultsTo Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Budesonide (6 mg)
Budesonide (9 mg)
Mesalazine (3,600 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative
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
Sites / Locations
- Ferring Investigator Site JPN27
- Ferring Investigator Site JPN52
- Ferring Investigator Site JPN47
- Ferring Investigator Site JPN69
- Ferring Investigator Site JPN68
- Ferring Investigator Site JPN53
- Ferring Investigator Site JPN08
- Ferring Investigator Site JPN50
- Ferring Investigator Site JPN51
- Ferring Investigator Site JPN31
- Ferring Investigator Site JPN64
- Ferring Investigator Site JPN28
- Ferring Investigator Site JPN19
- Ferring Investigator Site JPN23
- Ferring Investigator Site JPN35
- Ferring Investigator Site JPN38
- Ferring Investigator Site JPN36
- Ferring Investigator Site JPN17
- Ferring Investigator Site JPN46
- Ferring Investigator Site JPN11
- Ferring Investigator Site JPN59
- Ferring Investigator Site JPN61
- Ferring Investigator Site JPN14
- Ferring Investigator Site JPN13
- Ferring Investigator Site JPN40
- Ferring Investigator Site JPN43
- Ferring Investigator Site JPN24
- Ferring Investigator Site JPN22
- Ferring Investigator Site JPN41
- Ferring Investigator Site JPN02
- Ferring Investigator Site JPN29
- Ferring Investigator site JPN05
- Ferring Investigator Site JPN33
- Ferring Investigator Site JPN67
- Ferring Investigator Site JPN63
- Ferring Investigator Site JPN34
- Ferring Investigator Site JPN48
- Ferring Investigator Site JPN12
- Ferring Investigator site JPN04
- Ferring Investigator Site JPN44
- Ferring Investigator Site JPN66
- Ferring Investigator Site JPN62
- Ferring Investigator Site JPN55
- Ferring Investigator Site JPN37
- Ferring Investigator Site JPN01
- Ferring Investigator Site JPN72
- Ferring Investigator Site JPN65
- Ferring Investigator site JPN07
- Ferring Investigator Site JPN10
- Ferring Investigator Site JPN26
- Ferring Investigator Site JPN30
- Ferring Investigator Site JPN60
- Ferring Investigator Site JPN39
- Ferring Investigator Site JPN21
- Ferring Investigator Site JPN57
- Ferring Investigator Site JPN03
- Ferring Investigator Site JPN09
- Ferring Investigator Site JPN49
- Ferring Investigator Site JPN42
- Ferring Investigator Site JPN56
- Ferring Investigator Site JPN70
- Ferring Investigator Site JPN32
- Ferring Investigator Site JPN20
- Ferring Investigator Site JPN15
- Ferring Investigator site JPN06
- Ferring Investigator Site JPN58
- Ferring Investigator Site JPN71
- Ferring Investigator Site JPN18
- Ferring Investigator Site JPN54
- Ferring Investigator Site JPN45
- Ferring Investigator Site JPN16
- Ferring Investigator Site JPN25
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Budesonide (6 mg)
Budesonide (9 mg)
Mesalazine (3,600 mg)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of subjects achieving clinical remission after 8 weeks of treatment
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
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Change from baseline in partial UCDAI score at 2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Full Information
NCT ID
NCT03412682
First Posted
January 22, 2018
Last Updated
June 17, 2020
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03412682
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Budesonide (6 mg)
Arm Type
Experimental
Arm Title
Budesonide (9 mg)
Arm Type
Experimental
Arm Title
Mesalazine (3,600 mg)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Budesonide (6 mg)
Other Intervention Name(s)
FE 999315
Intervention Description
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Budesonide (9 mg)
Other Intervention Name(s)
FE 999315
Intervention Description
Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Mesalazine (3,600 mg)
Intervention Description
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Primary Outcome Measure Information:
Title
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
Description
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.
Time Frame
After 8 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving clinical remission after 8 weeks of treatment
Time Frame
8 weeks
Title
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
Time Frame
8 weeks
Title
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Time Frame
8 weeks
Title
Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1
Time Frame
8 weeks
Title
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Time Frame
2 weeks
Title
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Time Frame
4 weeks
Title
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Time Frame
8 weeks
Title
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Time Frame
8 weeks
Title
Change from baseline in partial UCDAI score at 2 weeks
Time Frame
2 weeks
Title
Change from baseline in partial UCDAI score at 4 weeks
Time Frame
4 weeks
Title
Change from baseline in partial UCDAI score at 8 weeks
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigator Site JPN27
City
Nagoya-shi
State/Province
Aichi
Country
Japan
Facility Name
Ferring Investigator Site JPN52
City
Toyoake-shi
State/Province
Aichi
Country
Japan
Facility Name
Ferring Investigator Site JPN47
City
Toyota-shi
State/Province
Aichi
Country
Japan
Facility Name
Ferring Investigator Site JPN69
City
Abiko-shi
State/Province
Chiba
Country
Japan
Facility Name
Ferring Investigator Site JPN68
City
Kashiwa-shi
State/Province
Chiba
Country
Japan
Facility Name
Ferring Investigator Site JPN53
City
Urayasu-shi
State/Province
Chiba
Country
Japan
Facility Name
Ferring Investigator Site JPN08
City
Matsuyama-shi
State/Province
Ehime
Country
Japan
Facility Name
Ferring Investigator Site JPN50
City
Fukui-shi
State/Province
Fukui
Country
Japan
Facility Name
Ferring Investigator Site JPN51
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN31
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN64
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN28
City
Kitakyushu-city
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN19
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN23
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN35
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN38
City
Kurume-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Ferring Investigator Site JPN36
City
Gifu-city
State/Province
Gifu
Country
Japan
Facility Name
Ferring Investigator Site JPN17
City
Takasaki-shi
State/Province
Gunma
Country
Japan
Facility Name
Ferring Investigator Site JPN46
City
Hatsukaichi-city
State/Province
Hiroshima
Country
Japan
Facility Name
Ferring Investigator Site JPN11
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Ferring Investigator Site JPN59
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Ferring Investigator Site JPN61
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Ferring Investigator Site JPN14
City
Kobe-shi
State/Province
Hyogo
Country
Japan
Facility Name
Ferring Investigator Site JPN13
City
Nishinomiya-shi
State/Province
Hyogo
Country
Japan
Facility Name
Ferring Investigator Site JPN40
City
Nishinomiya-shi
State/Province
Hyogo
Country
Japan
Facility Name
Ferring Investigator Site JPN43
City
Kasama-shi
State/Province
Ibaraki
Country
Japan
Facility Name
Ferring Investigator Site JPN24
City
Koga-shi
State/Province
Ibaraki
Country
Japan
Facility Name
Ferring Investigator Site JPN22
City
Tsuchiura-shi
State/Province
Ibaraki
Country
Japan
Facility Name
Ferring Investigator Site JPN41
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
Facility Name
Ferring Investigator Site JPN02
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Ferring Investigator Site JPN29
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Ferring Investigator site JPN05
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Ferring Investigator Site JPN33
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Ferring Investigator Site JPN67
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Ferring Investigator Site JPN63
City
Nankoku-shi
State/Province
Kochi
Country
Japan
Facility Name
Ferring Investigator Site JPN34
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
Facility Name
Ferring Investigator Site JPN48
City
Tsu-shi
State/Province
Mie
Country
Japan
Facility Name
Ferring Investigator Site JPN12
City
Yokkaichi-shi
State/Province
Mie
Country
Japan
Facility Name
Ferring Investigator site JPN04
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Ferring Investigator Site JPN44
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Ferring Investigator Site JPN66
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Ferring Investigator Site JPN62
City
Kashihara-shi
State/Province
Nara
Country
Japan
Facility Name
Ferring Investigator Site JPN55
City
Niigata-shi
State/Province
Niigata
Country
Japan
Facility Name
Ferring Investigator Site JPN37
City
Beppu-shi
State/Province
Oita
Country
Japan
Facility Name
Ferring Investigator Site JPN01
City
Oita-shi
State/Province
Oita
Country
Japan
Facility Name
Ferring Investigator Site JPN72
City
Oita-shi
State/Province
Oita
Country
Japan
Facility Name
Ferring Investigator Site JPN65
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
Ferring Investigator site JPN07
City
Fujiidera-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN10
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN26
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN30
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN60
City
Sakai-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN39
City
Suita-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN21
City
Takatsuki-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN57
City
Toyonaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Ferring Investigator Site JPN03
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Ferring Investigator Site JPN09
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Ferring Investigator Site JPN49
City
Sakura-shi
State/Province
Saitama
Country
Japan
Facility Name
Ferring Investigator Site JPN42
City
Tokorozawa-shi
State/Province
Saitama
Country
Japan
Facility Name
Ferring Investigator Site JPN56
City
Tokorozawa-shi
State/Province
Saitama
Country
Japan
Facility Name
Ferring Investigator Site JPN70
City
Mibu
State/Province
Tochigi
Country
Japan
Facility Name
Ferring Investigator Site JPN32
City
Fuchū-shi
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN20
City
Kodaira-shi
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN15
City
Machida-shi
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator site JPN06
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN58
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN71
City
Mitaka-shi
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN18
City
Oume-shi
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN54
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN45
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Ferring Investigator Site JPN16
City
Kofu-shi
State/Province
Yamanashi
Country
Japan
Facility Name
Ferring Investigator Site JPN25
City
Hiroshima-shi, Hiroshima
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
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