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

Ulcerative Colitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644665
• Other study ID #: IM047-010
• Status: Recruiting
• Phase: Phase 3
• Start date: December 9, 2022
• Est. completion date: April 14, 2027

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 14, 2027
• Est. primary completion date: April 14, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Ozanimod
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
China	Peking University International Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Local Institution - 0061	Changzhou	Jiangsu
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Cheng Du	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital Of Fujian Medical University	Fuzhou
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Local Institution - 0008	Guangzhou	Guangdong
China	Local Institution - 0020	Guangzhou	Guangdong
China	Local Institution - 0028	Guangzhou	Guangdong
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Qilu Hospital of Shandong University (Qingdao)	Jinan	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Local Institution - 0024	Nanjing	Jiangsu
China	Local Institution - 0023	Nanning	Guangxi
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital,Fudan University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Local Institution - 0006	Shijiazhuang	Hebei
China	The Second Afilliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Local Institution - 0009	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin People' s Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	HUB
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army	Xi'an	Shaanxi
China	Xijing Hospital	Xi'an	Shaanxi
China	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Taiwan	Changhua Christian Hospital	Changhua County	Changhua
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei
Taiwan	Local Institution - 0001	Taichung
Taiwan	Local Institution - 0059	Taichung
Taiwan	Local Institution - 0056	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Local Institution - 0060	Taipei City	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

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

External Links

•   BMS Clinical Trial Information