Colitis, UlcerativePhase 3NCT03915769
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Ozanimod in people with Colitis, Ulcerative, run by Celgene at 67 sites in Japan.
Trial summary
Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Ozanimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 67 sitesJapan
- Study dates
- 3 Jun 2019to 30 Sep 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Inclusion Criteria for Induction and Maintenance Periods
- Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening.
- Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report.
- Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
- Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1.
- Main Inclusion Criteria for Open-label Extension Period
Show all 9Show fewer
- Subjects must satisfy the following criteria to be enrolled in the study:
- Must have completed the Week 12 Visit and is non-responder at Week 12
- Who completes the IP and enters the MP, completes participation through the last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP
Who cannot join
- Main Exclusion Criteria
- Subject has severe extensive colitis
- Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis.
- Subject has positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4. Subject is pregnant or breastfeeding
- 5. Subject has clinically relevant cardiovascular conditions
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
Japan67 sites
Local Institution - 139
Abiko, 270-1168
Local Institution - 152
Aki-gun, 735-8585
Local Institution - 138
Bunkyo-ku, Tokyo, 1138519
Local Institution - 122
Chikushino-shi, 818-8502
Local Institution - 150
Fujiidera, 538-0027
Local Institution - 114
Fukui, 910-8526
Local Institution - 124
Fukui, 918-8503
Local Institution - 161
Fukuoka, 810-0001
Local Institution - 164
Fukuoka, 812-0033
Local Institution - 155
Fukuoka, 815-8555
Local Institution - 140
Gifu, 500-8717
Local Institution - 151
Hakodate, 040-8611
Local Institution - 133
Hirosaki, 036-8203
Local Institution - 160
Hiroshima, 734-8530
Local Institution - 106
Hiroshima, 734-8551
Local Institution - 126
Hitachi, Ibaraki, 317-0077
Local Institution - 162
Iizuka, 820-8505
Local Institution - 131
Iruma-gun, Saitama, 3500495
Local Institution - 134
Isehara City, Kanagawa, 259-1193
Local Institution - 120
Kahoku-gun, 920-0293
Local Institution - 135
Kannonji, 769-1695
Local Institution - 101
Kashihara, 634-8522
Local Institution - 158
Kashiwa, 277-0871
Local Institution - 157
Kawagoe, 350-8550
Local Institution - 163
Kobe, 650-0015
Local Institution - 130
Kobe, 650-0017
Local Institution - 121
Komatsu, 923-8560
Local Institution - 144
Kōriyama, 963-8501
Local Institution - 142
Kurume, 830-8543
Local Institution - 165
Kurume, 839-0809
Local Institution - 111
Kurume, Fukuoka, 830-0011
Local Institution - 141
Kyoto, 602-8566
Local Institution - 118
Matsuyama, 790-0024
Local Institution - 108
Minatoku, 105-8471
Local Institution - 107
Minatoku, 108-8642
Local Institution - 109
Mitaka, 181-8611
Local Institution - 110
Morioka, 020-8505
Local Institution - 125
Nagaoka, 940-8653
Local Institution - 167
Nagoya, 466-8560
Local Institution - 105
Nishinomiya, Hyōgo, 663-8501
Local Institution - 119
Ōgaki, 503-8502
Local Institution - 159
Ōita, 870-0823
Local Institution - 156
Okayama, Okayama-ken, 700-8558
Local Institution - 136
Okayama, 700-0013
Local Institution - 153
Osaka, Osaka, 530-0052
Local Institution - 132
Osaka, Osaka-shi, 545-8586
Local Institution - 127
Osaki-shi, 989-6183
Local Institution - 113
Ōtsu, 520-2192
Local Institution - 154
Saga, 849-8501
Local Institution - 116
Saitama, 336-0963
Local Institution - 145
Sakai, 591-8025
Local Institution - 102
Sakura, 285-8741
Local Institution - 104
Sapporo, Hokkaido, 060-8543
Local Institution - 103
Sapporo, 060-0033
Local Institution - 147
Sapporo, 062-8618
Local Institution - 146
Sendai, 980-0021
Local Institution - 128
Shinagawa-ku, Tokyo, 141-8625
Local Institution - 117
Shinjuku, 169-0073
Local Institution - 137
Shizuoka, 420-8630
Local Institution - 149
Sunto-gun, 411-8611
Local Institution - 112
Takamatsu, 760-8557
Local Institution - 115
Takatsuki, 569-0086
Local Institution - 143
Takatsuki, 569-1096
Local Institution - 166
Toshima-ku, 171-0021
Local Institution - 129
Toyama, 939-8511
Local Institution - 123
Tsu, 514-8507
Local Institution - 148
Utsunomiya, 320-0003
About this study
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.
Read the detailed description
Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.
- Conditions
- Colitis, Ulcerative
- Being tested
- Ozanimod, Placebo
- Keywords
- Ulcerative colitis, Ozanimod, colitis, Ulcerative
- Medical subject headings
- Colitis, Ulcerative, Colitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5
PlaceboOther
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.
| Study group | Role | What they receive |
|---|---|---|
| 0.46 mg ozanimod oral capsule once daily (QD) | Experimental | It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.46 mg ozanimod. Receives: Drug: Ozanimod |
| 0.92 mg ozanimod oral capsule QD | Experimental | It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.92 mg ozanimod. Receives: Drug: Ozanimod |
| Placebo oral capsule QD | Placebo comparator | It will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with a placebo capsule, followed by 3 days of treatment with two placebo capsules, followed by two placebo capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with clinical response
Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Measured: At Week 12
Secondary outcomes (9)
Proportion of subjects with clinical remission
Defined as: Definition 1. Complete Mayo score of ≤ 2 points with no individual subscore of > 1 point, Definition 2. Rectal bleeding subscore = 0 and stool frequency subscore ≤ 1 (and a decrease of ≥ 1 point from the Baseline stool frequency subscore) and endoscopy subscore ≤ 1
Measured: At Week 12 and Week 52
Proportion of subjects with a clinical response
Defined as a reduction from Baseline in the 9-point Mayo score of ≥ 2 points and ≥ 35%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Measured: At Week 12 and Week 52
Proportion of subjects with endoscopic improvement
Defined as an endoscopy subscore of ≤ 1 point
Measured: At Week 12 and Week 52
Proportion of subjects with mucosal healing
Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
Measured: At Week 12 and Week 52
Proportion of subjects with a clinical response
Defined as a reduction from Baseline in the partial Mayo score of ≥ 2 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Measured: At Week 9
Change in the EuroQol-5 Dimension (EQ-5D) from baseline
Is a quality of life questionnaires and will be collected from all subjects at visits
Measured: At Week 12
Proportion of subject with clinical response
Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
Measured: At week 52
Proportion of subjects in remission while off corticosteroids for any length of time
Proportion of subjects in remission while off corticosteroids for any length of time
Measured: Up to week 52
Adverse Event (AE)
Number of participants with adverse event.
Measured: From enrollment until at least 75 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start3 Jun 2019
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915769
- Sponsor's protocol ID
- RPC01-3103
- Other IDs
- U1111-1230-3228
- Status last verified
- Oct 2025
- First submitted
- 12 Apr 2019
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Publications
Hisamatsu T, Fujii T, Nakase H, Matsuoka K, Saruta M, Kobayashi T, Inoue S, Toriyama K, Wang D, Uchikawa Y, Fujimoto G, Hibi T. Efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis naive to immunomodulators or advanced therapies: post hoc analysis of the phase 2/3 J-True North study. Intest Res. 2026 Jul 10. doi: 10.5217/ir.2026.00031. Online ahead of print.
PubMed 42427283
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03915769
- Acronym / sponsor ID
- RPC01-3103
- Conditions
- Colitis, Ulcerative
- Keywords
- Ulcerative colitis, Ozanimod, colitis, Ulcerative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Apr 2019 (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.
Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.
Detailed description
Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.46 mg ozanimod oral capsule once daily (QD) | Experimental | Drug: OzanimodIt will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.46 mg ozanimod. |
| 0.92 mg ozanimod oral capsule QD | Experimental | Drug: OzanimodIt will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with 0.23 mg ozanimod, followed by 3 days of treatment with 0.46 mg ozanimod, followed by 0.92 mg ozanimod. |
| Placebo oral capsule QD | Placebo comparator | Other: PlaceboIt will be a 7-day dose escalation regimen in the IP consisting of 4 days of treatment with a placebo capsule, followed by 3 days of treatment with two placebo capsules, followed by two placebo capsules. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Main Inclusion Criteria for Induction and Maintenance Periods
- Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening.
- Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report.
- Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
- Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1.
Key exclusion criteria (5 listed)
- Main Exclusion Criteria
- Subject has severe extensive colitis
- Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis.
- Subject has positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4. Subject is pregnant or breastfeeding
- 5. Subject has clinically relevant cardiovascular conditions
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 |
|---|---|---|
| OzanimodOzanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5 | Drug | 0.46 mg ozanimod oral capsule once daily (QD), 0.92 mg ozanimod oral capsule QD |
| PlaceboThe placebo is a capsule that contains no study medication but looks exactly like the study medication capsule. | Other | Placebo oral capsule QD |
Primary outcome
Proportion of subjects with clinical response
Time frame: At Week 12
Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point
9 secondary outcomes
Proportion of subjects with clinical remission
Time frame: At Week 12 and Week 52
Proportion of subjects with a clinical response
Time frame: At Week 12 and Week 52
Proportion of subjects with endoscopic improvement
Time frame: At Week 12 and Week 52
Proportion of subjects with mucosal healing
Time frame: At Week 12 and Week 52
Proportion of subjects with a clinical response
Time frame: At Week 9
Change in the EuroQol-5 Dimension (EQ-5D) from baseline
Time frame: At Week 12
Proportion of subject with clinical response
Time frame: At week 52
Proportion of subjects in remission while off corticosteroids for any length of time
Time frame: Up to week 52
Adverse Event (AE)
Time frame: From enrollment until at least 75 days after completion of study treatment
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 15 Oct 2025.
- Derived from this study: PubMed 42427283Hisamatsu T, Fujii T, Nakase H, Matsuoka K, Saruta M, Kobayashi T, Inoue S, Toriyama K, Wang D, Uchikawa Y, Fujimoto G, Hibi T. Efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis naive to immunomodulators or advanced therapies: post hoc analysis of the phase 2/3 J-True North study. Intest Res. 2026 Jul 10. doi: 10.5217/ir.2026.00031. Online ahead of print.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
67 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 Ozanimod in people with Colitis, Ulcerative, run by Celgene at 67 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 9 inclusion and 5 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 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. Some participants in this study may receive a placebo. 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?
Proportion of subjects with clinical response (time frame: At Week 12). 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 NCT03915769, which also lists 1 linked publication.
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 15 Oct 2025.