A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis

Relapsing Multiple Sclerosis Clinical Trial

Official title:

A Phase 4, Multicenter, Single-arm, Open-label Study to Evaluate the Effectiveness and Safety of Oral Ozanimod for Relapsing Multiple Sclerosis (RMS) in Chinese Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06396039
• Other study ID #: IM047-1096
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2024
• Est. completion date: March 30, 2029

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect 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 assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: March 30, 2029
• Est. primary completion date: December 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Participants must have Multiple Sclerosis (MS) as diagnosed by the 2017 revision of the McDonald criteria.

• Participants must be exhibiting a relapsing clinical course consistent with Relapsing Multiple Sclerosis (RMS) and history of brain MRI lesions consistent with MS.

• Participants must have an EDSS score between 0 and 5.0 (both inclusive) at baseline.

Exclusion Criteria

• Participants must not have primary progressive MS at screening.

• Participants must not be diagnosed with, or suspected to have neuromyelitis optica spectrum disorder (NMOSD) by clinical symptoms, MRI appearance, and/or supportive serologies according to international consensus criteria.28 A positive test for aquaporin-4 (AQP4) by history or at screening is exclusionary.

• Participants must not have clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study in the opinion of the Investigator.

• Specific cardiac conditions are excluded, including history or presence of:.

i) Recent (within the past 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, New York Heart Association (NYHA) Class III/IV heart failure, or severe untreated sleep apnea.

ii) Second-degree (Mobitz type II) atrioventricular (AV) block, third-degree AV block, sick sinus syndrome, or sino-atrial block unless participants have a pacemaker in place.

iii) Prolonged corrected QT interval by Fredericia's formula (QTcF; > 450 msec males and > 470 msec females), or participants at additional risk for QT prolongation.

• Participants must not have diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 with hemoglobin A1c > 9%, or diabetic participants with significant comorbid conditions such as retinopathy or nephropathy.

• Participants must not receive a live vaccine or a live-attenuated vaccine within 4 weeks prior to first dose or planning to receive a live vaccine or a live-attenuated vaccine during the study or within 28 days after discontinuation from study intervention.

• Participants must not have a history of any significant drug allergy (such as anaphylaxis or hepatotoxicity).

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BMS-986374
Specified dose on specified days.

Locations

Country	Name	City	State
China	Local Institution - 0002	Beijing
China	Local Institution - 0009	Beijing	Beijing
China	Local Institution - 0005	Changchun	Jilin
China	Local Institution - 0011	Chengdu	Sichuan
China	Local Institution - 0012	Guangzhou	Guangdong
China	Local Institution - 0022	Guangzhou	Guangdong
China	Local Institution - 0010	Guiyang
China	Local Institution - 0019	Hangzhou	Zhejiang
China	Local Institution - 0006	Harbin	Heilongjiang
China	Local Institution - 0013	Hohhot
China	Local Institution - 0024	Kunming	Yunnan
China	Local Institution - 0025	Kunming	Yunnan
China	Local Institution - 0003	Nanchang	Jiangxi
China	Local Institution - 0014	Shanghai
China	Local Institution - 0016	Shanghai	Shanghai
China	Local Institution - 0021	Shenyang
China	Local Institution - 0008	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Local Institution - 0015	Taiyuan	Shan1xi
China	Tianjin Medical University General Hospital	Tianjin
China	Local Institution - 0023	Urumqi	Shan1xi
China	Local Institution - 0017	Wenzhou	Zhejiang
China	Local Institution - 0007	Wuhan	Hubei
China	Local Institution - 0020	Xianyang Shaanxi	Weicheng
China	Local Institution - 0018	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized relapse rate (ARR) over 36 months		Up to 3 years
Secondary	Annualized relapse rate (ARR) over 12 months and 24 months		Up to 2 years
Secondary	The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36		Up to 3 years
Secondary	The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36		Up to 3 years
Secondary	Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36		Up to 3 years
Secondary	Proportion of participants who are GdE lesion-free at Months 12, 24, and 36		Up to 3 years
Secondary	Proportion of participants with adverse events (AEs)		Up to 40 months
Secondary	Proportion of participants with serious adverse events (SAEs)		Up to 40 months
Secondary	Proportion of participants with AEs leading to discontinuation of study treatment		Up to 3 years
Secondary	Proportion of participants with laboratory abnormalities		Up to 40 months
Secondary	Proportion of participants with vital sign abnormalities		Up to 40 months
Secondary	Proportion of participants with electrocardiogram (ECG) abnormalities		Up to 40 months
Secondary	Proportion of participants with physical examination abnormalities		Up to 40 months
Secondary	Proportion of participants with serious or opportunistic infections		Up to 40 months
Secondary	Proportion of participants with malignancy		Up to 40 months
Secondary	Proportion of participants with bradycardia and heart condition abnormalities		Up to 40 months
Secondary	Proportion of participants with pulmonary toxicity		Up to 40 months
Secondary	Proportion of participants with macular edema		Up to 40 months
Secondary	Proportion of participants with hepatotoxicity		Up to 40 months
Secondary	Proportion of participants with posterior reversible encephalopathy syndrome		Up to 40 months
Secondary	Proportion of participants with progressive multifocal leukoencephalopathy		Up to 40 months

External Links

•   BMS Clinical Trial Information