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

NCT03412682 | Completed Phase 3

• 1 other identifier: 000234
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 72

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.

Conditions

Colitis, Ulcerative

Keywords

Ulcerative colitis; FE999315; Mesalazine; Colitis; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (3)

Budesonide (6 mg)

EXPERIMENTAL

Drug: Budesonide (6 mg)

Budesonide (9 mg)

EXPERIMENTAL

Drug: Budesonide (9 mg)

Mesalazine (3,600 mg)

ACTIVE COMPARATOR

Drug: Mesalazine (3,600 mg)

Interventions

Budesonide (6 mg) DRUG

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

Also known as: FE 999315

Budesonide (6 mg)

Budesonide (9 mg) DRUG

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

Also known as: FE 999315

Budesonide (9 mg)

Mesalazine (3,600 mg) DRUG

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

Mesalazine (3,600 mg)

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (72)

Ferring Investigator Site JPN27

Nagoya, Aichi-ken, Japan

Location

Ferring Investigator Site JPN52

Toyoake-shi, Aichi-ken, Japan

Location

Ferring Investigator Site JPN47

Toyota-shi, Aichi-ken, Japan

Location

Ferring Investigator Site JPN69

Abiko-shi, Chiba, Japan

Location

Ferring Investigator Site JPN68

Kashiwa-shi, Chiba, Japan

Location

Ferring Investigator Site JPN53

Urayasu-shi, Chiba, Japan

Location

Ferring Investigator Site JPN08

Matsuyama, Ehime, Japan

Location

Ferring Investigator Site JPN50

Fukui-shi, Fukui, Japan

Location

Ferring Investigator Site JPN51

Chikushino-shi, Fukuoka, Japan

Location

Ferring Investigator Site JPN31

Fukuoka, Fukuoka, Japan

Location

Ferring Investigator Site JPN64

Fukuoka, Fukuoka, Japan

Location

Ferring Investigator Site JPN28

Kitakyushu, Fukuoka, Japan

Location

Ferring Investigator Site JPN19

Kitakyushu-shi, Fukuoka, Japan

Location

Ferring Investigator Site JPN23

Kitakyushu-shi, Fukuoka, Japan

Location

Ferring Investigator Site JPN35

Kitakyushu-shi, Fukuoka, Japan

Location

Ferring Investigator Site JPN38

Kurume-shi, Fukuoka, Japan

Location

Ferring Investigator Site JPN36

Gifu, Gifu, Japan

Location

Ferring Investigator Site JPN17

Takasaki-shi, Gunma, Japan

Location

Ferring Investigator Site JPN46

Hatsukaichi, Hiroshima, Japan

Location

Ferring Investigator Site JPN11

Asahikawa-shi, Hokkaido, Japan

Location

Ferring Investigator Site JPN59

Hakodate-shi, Hokkaido, Japan

Location

Ferring Investigator Site JPN61

Sapporo, Hokkaido, Japan

Location

Ferring Investigator Site JPN14

Kobe, Hyōgo, Japan

Location

Ferring Investigator Site JPN13

Nishinomiya-shi, Hyōgo, Japan

Location

Ferring Investigator Site JPN40

Nishinomiya-shi, Hyōgo, Japan

Location

Ferring Investigator Site JPN43

Kasama-shi, Ibaraki, Japan

Location

Ferring Investigator Site JPN24

Koga-shi, Ibaraki, Japan

Location

Ferring Investigator Site JPN22

Tsuchiura-shi, Ibaraki, Japan

Location

Ferring Investigator Site JPN41

Takamatsu, Kagawa-ken, Japan

Location

Ferring Investigator Site JPN02

Kagoshima, Kagoshima-ken, Japan

Location

Ferring Investigator Site JPN29

Kagoshima, Kagoshima-ken, Japan

Location

Ferring Investigator site JPN05

Yokohama, Kanagawa, Japan

Location

Ferring Investigator Site JPN33

Yokohama, Kanagawa, Japan

Location

Ferring Investigator Site JPN67

Yokohama, Kanagawa, Japan

Location

Ferring Investigator Site JPN63

Nankoku-shi, Kochi, Japan

Location

Ferring Investigator Site JPN34

Kyoto, Kyoto, Japan

Location

Ferring Investigator Site JPN48

Tsu, Mie-ken, Japan

Location

Ferring Investigator Site JPN12

Yokkaichi-shi, Mie-ken, Japan

Location

Ferring Investigator site JPN04

Sendai, Miyagi, Japan

Location

Ferring Investigator Site JPN44

Nagasaki, Nagasaki, Japan

Location

Ferring Investigator Site JPN66

Nagasaki, Nagasaki, Japan

Location

Ferring Investigator Site JPN62

Kashihara-shi, Nara, Japan

Location

Ferring Investigator Site JPN55

Niigata, Niigata, Japan

Location

Ferring Investigator Site JPN37

Beppu-shi, Oita Prefecture, Japan

Location

Ferring Investigator Site JPN01

Ōita, Oita Prefecture, Japan

Location

Ferring Investigator Site JPN72

Ōita, Oita Prefecture, Japan

Location

Ferring Investigator Site JPN65

Okayama, Okayama-ken, Japan

Location

Ferring Investigator site JPN07

Fujiidera-shi, Osaka, Japan

Location

Ferring Investigator Site JPN10

Osaka, Osaka, Japan

Location

Ferring Investigator Site JPN26

Osaka, Osaka, Japan

Location

Ferring Investigator Site JPN30

Osaka, Osaka, Japan

Location

Ferring Investigator Site JPN60

Sakai-shi, Osaka, Japan

Location

Ferring Investigator Site JPN39

Suita-shi, Osaka, Japan

Location

Ferring Investigator Site JPN21

Takatsuki-shi, Osaka, Japan

Location

Ferring Investigator Site JPN57

Toyonaka-shi, Osaka, Japan

Location

Ferring Investigator Site JPN03

Saitama-shi, Saitama, Japan

Location

Ferring Investigator Site JPN09

Saitama-shi, Saitama, Japan

Location

Ferring Investigator Site JPN49

Sakura-shi, Saitama, Japan

Location

Ferring Investigator Site JPN42

Tokorozawa-shi, Saitama, Japan

Location

Ferring Investigator Site JPN56

Tokorozawa-shi, Saitama, Japan

Location

Ferring Investigator Site JPN70

Mibu, Tochigi, Japan

Location

Ferring Investigator Site JPN32

Fuchū-shi, Tokyo, Japan

Location

Ferring Investigator Site JPN20

Kodaira-shi, Tokyo, Japan

Location

Ferring Investigator Site JPN15

Machida-shi, Tokyo, Japan

Location

Ferring Investigator site JPN06

Meguro-ku, Tokyo, Japan

Location

Ferring Investigator Site JPN58

Minato-ku, Tokyo, Japan

Location

Ferring Investigator Site JPN71

Mitaka-shi, Tokyo, Japan

Location

Ferring Investigator Site JPN18

Oume-shi, Tokyo, Japan

Location

Ferring Investigator Site JPN54

Shinagawa-Ku, Tokyo, Japan

Location

Ferring Investigator Site JPN45

Shinjuku-Ku, Tokyo, Japan

Location

Ferring Investigator Site JPN16

Kofu, Yamanashi, Japan

Location

Ferring Investigator Site JPN25

Hiroshima-shi, Hiroshima, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis

Interventions

Budesonide; Mesalamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 26, 2018
• Study Start: March 2, 2018
• Primary Completion: May 11, 2020
• Study Completion: May 26, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

JP (72)