A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)

The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Ozanimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Fuzhou, China, 350005
    • Local Institution - 0048
  • Shanghai, China, 200120
    • Local Institution - 0053
  • Anhui
    • Hefei, Anhui, China, 230071
      • Local Institution - 0012
    • Wuhu, Anhui, China, 241001
      • Local Institution - 0013
  • Beijing
    • Beijing, Beijing, China, 102206
      • Local Institution - 0052
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Local Institution - 0050
  • Fujian
    • Xiamen, Fujian, China, 361004
      • Local Institution - 0011
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Local Institution - 0019
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0020
    • Guangzhou, Guangdong, China, 510180
      • Local Institution - 0036
    • Guangzhou, Guangdong, China, 510280
      • Local Institution - 0028
    • Guangzhou, Guangdong, China, 510655
      • Local Institution - 0008
    • Zhanjiang, Guangdong, China, 524004
      • Local Institution - 0004
  • Guangxi
    • Guilin, Guangxi, China, 541001
      • Local Institution - 0051
  • HUB
    • Wuhan, HUB, China, 430060
      • Local Institution - 0033
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Local Institution - 0007
    • Shijiazhuang, Hebei, China, 050011
      • Local Institution - 0006
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 0040
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0037
  • Hunan
    • Changsha, Hunan, China, 410008
      • Local Institution - 0027
    • Changsha, Hunan, China, 410013
      • Local Institution - 0022
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Local Institution - 0061
    • Changzhou, Jiangsu, China, 213003
      • Local Institution - 0046
    • Nanjing, Jiangsu, China, 210000
      • Local Institution - 0024
    • Nanjing, Jiangsu, China, 210029
      • Local Institution - 0045
    • Suzhou, Jiangsu, China, 215004
      • Local Institution - 0018
    • Suzhou, Jiangsu, China, 215006
      • Local Institution - 0009
    • Wuxi, Jiangsu, China, 214023
      • Local Institution - 0044
    • Zhenjiang, Jiangsu, China, 212000
      • Local Institution - 0042
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Local Institution - 0010
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Local Institution - 0029
    • Xi'an, Shaanxi, China, 710038
      • Local Institution - 0026
  • Shandong
    • Jinan, Shandong, China, 250014
      • Local Institution - 0039
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Local Institution - 0034
    • Shanghai, Shanghai, China, 200025
      • Local Institution - 0035
    • Shanghai, Shanghai, China, 200032
      • Local Institution - 0041
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Local Institution - 0015
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • Local Institution - 0032
    • Chengdu, Sichuan, China, 610072
      • Local Institution - 0025
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Local Institution - 0031
    • Tianjin, Tianjin, China, 300121
      • Local Institution - 0047
  • Yunnan
    • Kunming, Yunnan, China, 650034
      • Local Institution - 0049
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution - 0030
• Taiwan
  • New Taipei, Taiwan, 235
    • Local Institution - 0058
  • Taichung, Taiwan, 40447
    • Local Institution - 0001
  • Taichung, Taiwan, 407
    • Local Institution - 0059
  • Taipei, Taiwan, 10002
    • Local Institution - 0056
  • Taipei, Taiwan, 11217
    • Local Institution - 0057
  • Taoyuan, Taiwan, 333
    • Local Institution - 0055
  • Changhua
    • Changhua County, Changhua, Taiwan, 50006
      • Local Institution - 0054
  • Taipei
    • Taipei City, Taipei, Taiwan, 114
      • Local Institution - 0060

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Main Study:

• Eligible participants must be Chinese.
• Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.

Open-label Extension Period:

• Participants who have completed the Week 10 Visit and are non-responders at Week 10.
• Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.

Exclusion Criteria:

Main Study and Open-label Extension Period:

• Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis.

Open-label Extension Period:

• Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period.
• Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Ozanimod	Drug: Ozanimod; Specified dose on specified days; Other Names: BMS-986374
Placebo Comparator: Arm B: Placebo	Drug: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with clinical remission as measured by the 3-component Mayo Score	At week 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with clinical remission as measured by the 3-component Mayo Score	At week 52
Proportion of participants with clinical response as measured by the 3-component Mayo Score	At week 10 and at week 52
Proportion of participants with endoscopic improvement	At week 10 and at week 52
Proportion of participants achieving histologic remission	At week 10 and at week 52
Proportion of participants with mucosal healing	At week 10 and at week 52
Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks	At week 52
Proportion of participants with Treatment Emergent Adverse Events (TEAEs)	Up to 78 weeks
Proportion of participants with Serious Adverse Events (SAEs)	Up to 78 weeks
Proportion of participants with TEAEs leading to discontinuation of investigational product	Up to 78 weeks
Proportion of participants with TEAEs of special interest	Up to 78 weeks
Proportion of participants with clinical laboratory abnormalities	Up to 78 weeks
Proportion of participants with vital sign abnormalities	Up to 78 weeks
Proportion of participants with electrocardiogram (ECG) abnormalities	Up to 78 weeks
Proportion of participants with pulmonary function test abnormalities	Up to 78 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Actual): March 7, 2025
• Study Completion (Actual): March 7, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Ozanimod
• Other Study ID Numbers: IM047-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No