To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

January 3, 2024 updated by: Celgene

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

195

Phase

  • 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

      • Abiko, Japan, 270-1168
        • Local Institution - 139
      • Aki-gun, Japan, 735-8585
        • Local Institution - 152
      • Chikushino, Japan, 818-8502
        • Local Institution - 122
      • Fujiidera, Japan, 538-0027
        • Local Institution - 150
      • Fukui, Japan, 910-8526
        • Local Institution - 114
      • Fukui, Japan, 918-8503
        • Local Institution - 124
      • Fukuoka, Japan, 810-0001
        • Local Institution - 161
      • Fukuoka, Japan, 812-0033
        • Local Institution - 164
      • Fukuoka, Japan, 815-8555
        • Local Institution - 155
      • Gifu, Japan, 500-8717
        • Local Institution - 140
      • Hakodate, Japan, 040-8611
        • Local Institution - 151
      • Hirosaki, Japan, 036-8203
        • Local Institution - 133
      • Hiroshima, Japan, 734-8530
        • Local Institution - 160
      • Hiroshima, Japan, 734-8551
        • Local Institution - 106
      • Hitachi, Ibaraki, Japan, 317-0077
        • Local Institution - 126
      • Iizuka, Japan, 820-8505
        • Local Institution - 162
      • Isehara City, Kanagawa, Japan, 259-1193
        • Local Institution - 134
      • Kahoku-gun, Japan, 920-0293
        • Local Institution - 120
      • Kannonji, Japan, 769-1695
        • Local Institution - 135
      • Kashihara, Japan, 634-8522
        • Local Institution - 101
      • Kashiwa, Japan, 277-0871
        • Local Institution - 158
      • Kawagoe, Japan, 350-8550
        • Local Institution - 157
      • Kobe, Japan, 650-0015
        • Local Institution - 163
      • Kobe, Japan, 650-0017
        • Local Institution - 130
      • Komatsu, Japan, 923-8560
        • Local Institution - 121
      • Koriyama, Japan, 963-8501
        • Local Institution - 144
      • Kurume, Japan, 830-8543
        • Local Institution - 142
      • Kurume, Japan, 839-0809
        • Local Institution - 165
      • Kurume, Fukuoka, Japan, 830-0011
        • Local Institution - 111
      • Kyoto-city, Japan, 602-8566
        • Local Institution - 141
      • Matsuyama, Japan, 790-0024
        • Local Institution - 118
      • Minato-ku, Japan, 105-8471
        • Local Institution - 108
      • Minato-ku, Japan, 108-8642
        • Local Institution - 107
      • Mitaka, Japan, 181-8611
        • Local Institution - 109
      • Morioka, Japan, 020-8505
        • Local Institution - 110
      • Nagaoka, Japan, 940-8653
        • Local Institution - 125
      • Nagoya-shi, Japan, 466-8560
        • Local Institution - 167
      • Ogaki, Japan, 503-8502
        • Local Institution - 119
      • Oita, Japan, 870-0823
        • Local Institution - 159
      • Okayama, Japan, 700-0013
        • Local Institution - 136
      • Osaki-shi, Japan, 989-6183
        • Local Institution - 127
      • Otsu, Japan, 520-2192
        • Local Institution - 113
      • Saga, Japan, 849-8501
        • Local Institution - 154
      • Saitama, Japan, 336-0963
        • Local Institution - 116
      • Sakai, Japan, 591-8025
        • Local Institution - 145
      • Sakura, Japan, 285-8741
        • Local Institution - 102
      • Sapporo, Japan, 060-0033
        • Local Institution - 103
      • Sapporo, Japan, 062-8618
        • Local Institution - 147
      • Sendai, Japan, 980-0021
        • Local Institution - 146
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Local Institution - 128
      • Shinju-ku, Japan, 169-0073
        • Local Institution - 117
      • Shizuoka-shi, Japan, 420-8630
        • Local Institution - 137
      • Sunto-gun, Japan, 411-8611
        • Local Institution - 149
      • Takamatsu, Japan, 760-8557
        • Local Institution - 112
      • Takatsuki, Japan, 569-0086
        • Local Institution - 115
      • Takatsuki, Japan, 569-1096
        • Local Institution - 143
      • Toshima-ku, Japan, 171-0021
        • Local Institution - 166
      • Toyama, Japan, 939-8511
        • Local Institution - 129
      • Tsu, Japan, 514-8507
        • Local Institution - 123
      • Utsunomiya, Japan, 320-0003
        • Local Institution - 148
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Local Institution - 104
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Local Institution - 105
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Local Institution - 156
    • Osaka
      • Osaka-shi, Osaka, Japan, 530-0052
        • Local Institution - 153
    • Osaka-shi
      • Osaka, Osaka-shi, Japan, 545-8586
        • Local Institution - 132
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution - 131
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Local Institution - 138

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Main Inclusion Criteria for Induction and Maintenance Periods

  1. 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.
  2. 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.
  3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
  4. 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

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Must have completed the Week 12 Visit and is non-responder at Week 12
  2. 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

Exclusion Criteria:

Main Exclusion Criteria

  1. Subject has severe extensive colitis
  2. 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.
  3. 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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.46 mg ozanimod oral capsule once daily (QD)
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.
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
Experimental: 0.92 mg ozanimod oral capsule QD
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.
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
Placebo Comparator: Placebo oral capsule QD
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.
The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with clinical remission
Time Frame: At Week 12 and Week 52
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
At Week 12 and Week 52
Proportion of subjects with endoscopic improvement
Time Frame: At Week 12 and Week 52
Defined as an endoscopy subscore of ≤ 1 point
At Week 12 and Week 52
Proportion of subjects with mucosal healing
Time Frame: At Week 12 and Week 52
Defined as an endoscopy subscore of ≤ 1 point and a Geboes index score < 2.0
At Week 12 and Week 52
Proportion of subjects with a clinical response
Time Frame: At Week 9
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
At Week 9
Change in the EuroQol-5 Dimension (EQ-5D) from baseline
Time Frame: At Week 12
Is a quality of life questionnaires and will be collected from all subjects at visits
At Week 12
Proportion of subject with clinical response
Time Frame: At week 52
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
At week 52
Proportion of subjects in remission while off corticosteroids for any length of time
Time Frame: Up to week 52
Proportion of subjects in remission while off corticosteroids for any length of time
Up to week 52
Adverse Event (AE)
Time Frame: From enrollment until at least 75 days after completion of study treatment
Number of participants with adverse event.
From enrollment until at least 75 days after completion of study treatment
Proportion of subjects with a clinical response
Time Frame: At Week 12 and Week 52
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
At Week 12 and Week 52

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 3, 2019

Primary Completion (Estimated)

March 13, 2025

Study Completion (Estimated)

March 13, 2025

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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