Clinical trial NCT05644665: A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Proportion of participants with clinical remission as measured by the 3-component Mayo Score
timeFrame: At week 10
Secondary outcomes:
measure: Proportion of participants with clinical remission as measured by the 3-component Mayo Score
timeFrame: At week 52
measure: Proportion of participants with clinical response as measured by the 3-component Mayo Score
timeFrame: At week 10 and at week 52
measure: Proportion of participants with endoscopic improvement
timeFrame: At week 10 and at week 52
measure: Proportion of participants achieving histologic remission
timeFrame: At week 10 and at week 52
measure: Proportion of participants with mucosal healing
timeFrame: At week 10 and at week 52
measure: Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks
timeFrame: At week 52
measure: Proportion of participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 78 weeks
measure: Proportion of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 78 weeks
measure: Proportion of participants with TEAEs leading to discontinuation of investigational product
timeFrame: Up to 78 weeks
measure: Proportion of participants with TEAEs of special interest
timeFrame: Up to 78 weeks
measure: Proportion of participants with clinical laboratory abnormalities
timeFrame: Up to 78 weeks
measure: Proportion of participants with vital sign abnormalities
timeFrame: Up to 78 weeks
measure: Proportion of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 78 weeks
measure: Proportion of participants with pulmonary function test abnormalities
timeFrame: Up to 78 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Local Institution - 0012
state: Anhui
city: Wuhu
country: China
facility: Local Institution - 0013
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0052
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0050
state: Chongqing
city: Xiamen
country: China
facility: Local Institution - 0011
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0020
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0036
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0028
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0019
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0008
state: Guangdong
city: Zhanjiang
country: China
facility: Local Institution - 0004
state: Guangdong
city: Guilin
country: China
facility: Local Institution - 0051
state: Guangxi
city: Shijiazhuang
country: China
facility: Local Institution - 0007
state: Hebei
city: Shijiazhuang
country: China
facility: Local Institution - 0006
state: Hebei
city: Wuhan
country: China
facility: Local Institution - 0040
state: Hubei
city: Wuhan
country: China
facility: Local Institution - 0037
state: Hubei
city: Wuhan
country: China
facility: Local Institution - 0033
state: HUB
city: Changsha
country: China
facility: Local Institution - 0027
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0022
state: Hunan
city: Changzhou
country: China
facility: Local Institution - 0061
state: Jiangsu
city: Changzhou
country: China
facility: Local Institution - 0046
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0024
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0045
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution - 0018
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution - 0009
state: Jiangsu
city: Wuxi
country: China
facility: Local Institution - 0044
state: Jiangsu
city: Zhenjiang
country: China
facility: Local Institution - 0042
state: Jiangsu
city: Shenyang
country: China
facility: Local Institution - 0010
state: Liaoning
city: Xi'an
country: China
facility: Local Institution - 0029
state: Shaanxi
city: Xi'an
country: China
facility: Local Institution - 0026
state: Shaanxi
city: Jinan
country: China
facility: Local Institution - 0039
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0035
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0041
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0034
state: Shanghai
city: Taiyuan
country: China
facility: Local Institution - 0015
state: Shanxi
city: Cheng Du
country: China
facility: Local Institution - 0032
state: Sichuan
city: Chengdu
country: China
facility: Local Institution - 0025
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0031
state: Tianjin
city: Tianjin
country: China
facility: Local Institution - 0047
state: Tianjin
city: Kunming
country: China
facility: Local Institution - 0049
state: Yunnan
city: Hangzhou
country: China
facility: Local Institution - 0030
state: Zhejiang
city: Fuzhou
country: China
facility: Local Institution - 0048
city: Shanghai
country: China
facility: Local Institution - 0053
city: Changhua County
country: Taiwan
facility: Local Institution - 0054
state: Changhua
city: Taipei City
country: Taiwan
facility: Local Institution - 0060
state: Taipei
city: New Taipei
country: Taiwan
facility: Local Institution - 0058
city: Taichung
country: Taiwan
facility: Local Institution - 0001
city: Taichung
country: Taiwan
facility: Local Institution - 0059
city: Taipei
country: Taiwan
facility: Local Institution - 0056
city: Taipei
country: Taiwan
facility: Local Institution - 0057
city: Taoyuan
country: Taiwan
facility: Local Institution - 0055
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: