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

June 17, 2020 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Budesonide (6 mg)
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.
Other Names:
  • FE 999315
Experimental: Budesonide (9 mg)
Drug: 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.
Other Names:
  • FE 999315
Active Comparator: Mesalazine (3,600 mg)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score
Time Frame: 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.
After 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of subjects achieving clinical remission after 8 weeks of treatment
Time Frame: 8 weeks
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
Time Frame: 8 weeks
8 weeks
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Time Frame: 8 weeks
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
Time Frame: 8 weeks
8 weeks
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Time Frame: 2 weeks
2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Time Frame: 4 weeks
4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Time Frame: 8 weeks
8 weeks
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Time Frame: 8 weeks
8 weeks
Change from baseline in partial UCDAI score at 2 weeks
Time Frame: 2 weeks
2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Time Frame: 4 weeks
4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000234

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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