Colitis, UlcerativePhase 3NCT03412682

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

A Phase 3 study testing Budesonide (6 mg), Budesonide (9 mg) and Mesalazine (3,600 mg) in people with Colitis, Ulcerative, run by Ferring Pharmaceuticals at 72 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Colitis, Ulcerative
What is being tested?: Budesonide (6 mg), Budesonide (9 mg) and Mesalazine (3,600 mg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 72 sitesJapan
Study dates: 2 Mar 2018to 26 May 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

72 sites in 1 country.

City, postcode or hospital

72 sites in 1 country

Japan72 sites

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

Other trials in Japan

About this study

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

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
Being tested: Budesonide (6 mg), Budesonide (9 mg), Mesalazine (3,600 mg)
Keywords: Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative
Medical subject headings: Colitis, Ulcerative, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide (6 mg)Drug
Also called FE 999315
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)Drug
Also called FE 999315
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)Drug
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.

Study groups in NCT03412682
Study group	Role	What they receive
Budesonide (6 mg)	Experimental	Not described Receives: Drug: Budesonide (6 mg)
Budesonide (9 mg)	Experimental	Not described Receives: Drug: Budesonide (9 mg)
Mesalazine (3,600 mg)	Active comparator	Not described Receives: Drug: Mesalazine (3,600 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: After 8 weeks

Secondary outcomes (11)

Percentage of subjects achieving clinical remission after 8 weeks of treatment
Measured: 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
Measured: 8 weeks
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Measured: 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
Measured: 8 weeks
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Measured: 2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Measured: 4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Measured: 8 weeks
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Measured: 8 weeks
Change from baseline in partial UCDAI score at 2 weeks
Measured: 2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Measured: 4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201826 May 2020

First posted26 Jan 2018
Study start2 Mar 2018
Primary completion11 May 2020
Study completion26 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03412682
Sponsor's protocol ID: 000234
Status last verified: Jun 2020
First submitted: 22 Jan 2018
Last updated: 18 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03412682
Acronym / sponsor ID: 000234
Conditions: Colitis, Ulcerative
Keywords: Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 2 Mar 2018 (actual)
Primary completion: 11 May 2020 (actual)
Study completion: 26 May 2020 (actual)
First posted: 26 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
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)

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide (6 mg)Also: FE 999315Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.	Drug	Budesonide (6 mg)
Budesonide (9 mg)Also: FE 999315Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.	Drug	Budesonide (9 mg)
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.	Drug	Mesalazine (3,600 mg)

Primary outcome

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.

11 secondary outcomes

Percentage of subjects achieving clinical remission after 8 weeks of treatment
Time frame: 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
Percentage of subjects achieving clinical improvement after 8 weeks of treatment
Time frame: 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
Percentage of subjects achieving symptom resolution after 2 weeks of treatment
Time frame: 2 weeks
Percentage of subjects achieving symptom resolution after 4 weeks of treatment
Time frame: 4 weeks
Percentage of subjects achieving symptom resolution after 8 weeks of treatment
Time frame: 8 weeks
Percentage of subjects with endoscopic healing after 8 weeks of treatment
Time frame: 8 weeks
Change from baseline in partial UCDAI score at 2 weeks
Time frame: 2 weeks
Change from baseline in partial UCDAI score at 4 weeks
Time frame: 4 weeks
Change from baseline in partial UCDAI score at 8 weeks
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Compliance study director

Ferring Pharmaceuticals

72 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide (6 mg), Budesonide (9 mg) and Mesalazine (3,600 mg) in people with Colitis, Ulcerative, run by Ferring Pharmaceuticals at 72 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.