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

Last updated: March 25, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Terminated

Phase

3

Condition

Ulcerative Colitis

Colic

Inflammatory Bowel Disease

Treatment

Placebo

Ozanimod

Clinical Study ID

NCT05644665
IM047-010
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Main Study:

  • Eligible participants must be Chinese.

  • Participant has had moderately to severely active UC diagnosed at least 3 monthsprior 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 MaintenancePeriod experienced disease relapse during the Maintenance Period, or who havecompleted the Maintenance Period at Week 52.

Exclusion

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, radiationcolitis, or ischemic colitis.

Open-label Extension Period:

  • Participant has clinically relevant hepatic, neurological, pulmonary,ophthalmological, endocrine, psychiatric, or other major systemic disease makingimplementation of the protocol or interpretation of the study difficult or thatwould put the participant at risk by continuing the study or that would haverequired a participant to discontinue treatment were observed during the InductionPeriod or Maintenance Period.

  • Participant has clinically relevant cardiovascular conditions, including history orpresence of recent myocardial infarction, unstable angina, stroke, transientischemic attack, decompensated heart failure requiring hospitalization, Class III/IVheart failure, sick sinus syndrome, or severe untreated sleep apnea were observedduring the Induction Period or Maintenance Period.

Study Design

Total Participants: 131
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 09, 2022
Estimated Completion Date:
March 07, 2025

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230071
    China

    Active - Recruiting

  • Local Institution - 0012

    Hefei, Anhui 230071
    China

    Site Not Available

  • Local Institution - 0013

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Active - Recruiting

  • Local Institution - 0052

    Beijing, Beijing 102206
    China

    Site Not Available

  • Peking University International Hospital

    Beijing, Beijing 102206
    China

    Active - Recruiting

  • Chongqing General Hospital

    Chongqing, Chongqing 400014
    China

    Active - Recruiting

  • Local Institution - 0050

    Chongqing, Chongqing 400014
    China

    Site Not Available

  • Local Institution - 0011

    Xiamen, Fujian 361004
    China

    Site Not Available

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian 361004
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Active - Recruiting

  • Local Institution - 0008

    Guangzhou, Guangdong 510655
    China

    Site Not Available

  • Local Institution - 0019

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Local Institution - 0020

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Local Institution - 0028

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • Local Institution - 0036

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • Zhujiang Hospital

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong 524004
    China

    Active - Recruiting

  • Local Institution - 0004

    Zhanjiang, Guangdong 524004
    China

    Site Not Available

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541001
    China

    Active - Recruiting

  • Local Institution - 0051

    Guilin, Guangxi 541001
    China

    Site Not Available

  • Local Institution - 0023

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Local Institution - 0033

    Wuhan, HUB 430060
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, HUB 430060
    China

    Active - Recruiting

  • Local Institution - 0007

    Jiazhuang, Hebei 050000
    China

    Site Not Available

  • Local Institution - 0006

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Local Institution - 0007

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei 050011
    China

    Active - Recruiting

  • The Second Afilliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Local Institution - 0037

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Local Institution - 0040

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Local Institution - 0022

    Changsha, Hunan 410013
    China

    Site Not Available

  • Local Institution - 0027

    Changsha, Hunan 410008
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu 0
    China

    Active - Recruiting

  • Local Institution - 0046

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Local Institution - 0061

    Changzhou, Jiangsu 0
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 213003
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Local Institution - 0024

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Local Institution - 0045

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Local Institution - 0009

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Local Institution - 0018

    Suzhou, Jiangsu 215004
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215004
    China

    Active - Recruiting

  • Local Institution - 0044

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Active - Recruiting

  • Local Institution - 0042

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • Local Institution - 0010

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • Local Institution - 0026

    Xi'an, Shaanxi 710038
    China

    Site Not Available

  • Local Institution - 0029

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

    Xi'an, Shaanxi 710038
    China

    Active - Recruiting

  • Xijing Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

  • Local Institution - 0039

    Jinan, Shandong 250014
    China

    Site Not Available

  • Qilu Hospital of Shandong University (Qingdao)

    Jinan, Shandong 250014
    China

    Active - Recruiting

  • Local Institution - 0034

    Shanghai, Shanghai 200092
    China

    Site Not Available

  • Local Institution - 0035

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Local Institution - 0041

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

  • Zhongshan Hospital,Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Local Institution - 0015

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • Local Institution - 0032

    Cheng Du, Sichuan 610041
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • Local Institution - 0025

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan 610072
    China

    Active - Recruiting

  • Local Institution - 0031

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Local Institution - 0047

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Tianjin People' s Hospital

    Tianjin, Tianjin 300121
    China

    Active - Recruiting

  • Local Institution - 0049

    Kunming, Yunnan 650034
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan 650034
    China

    Active - Recruiting

  • Local Institution - 0030

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • Local Institution - 0048

    Fuzhou, 350005
    China

    Site Not Available

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005
    China

    Active - Recruiting

  • Local Institution - 0053

    Shanghai, 200120
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, 200120
    China

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua County, Changhua 50006
    Taiwan

    Active - Recruiting

  • Local Institution - 0054

    Changhua County, Changhua 50006
    Taiwan

    Site Not Available

  • Local Institution - 0060

    Taipei City, Taipei 114
    Taiwan

    Site Not Available

  • Local Institution - 0058

    New Taipei, 235
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei, 235
    Taiwan

    Active - Recruiting

  • Local Institution - 0001

    Taichung, 40447
    Taiwan

    Site Not Available

  • Local Institution - 0059

    Taichung, 407
    Taiwan

    Site Not Available

  • Local Institution - 0002

    Taipei, 11217
    Taiwan

    Site Not Available

  • Local Institution - 0056

    Taipei, 10002
    Taiwan

    Site Not Available

  • Local Institution - 0057

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Local Institution - 0055

    Taoyuan, 333
    Taiwan

    Site Not Available

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