Clinical trial NCT06396039: A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-05-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness and safety of ozanimod in Chinese adults with relapsing multiple sclerosis.


Eligibility criteria: 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.

Primary outcomes:
measure: Annualized relapse rate (ARR) over 36 months
timeFrame: Up to 3 years
Secondary outcomes:
measure: Annualized relapse rate (ARR) over 12 months and 24 months
timeFrame: Up to 2 years
measure: The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions at Months 12, 24, and 36
timeFrame: Up to 3 years
measure: The cumulative number of GdE brain MRI lesions at Months 12, 24, and 36
timeFrame: Up to 3 years
measure: Proportion of participants who are new or enlarging hyperintense T2 lesion free at Months 12, 24, and 36
timeFrame: Up to 3 years
measure: Proportion of participants who are GdE lesion-free at Months 12, 24, and 36
timeFrame: Up to 3 years
measure: Proportion of participants with adverse events (AEs)
timeFrame: Up to 40 months
measure: Proportion of participants with serious adverse events (SAEs)
timeFrame: Up to 40 months
measure: Proportion of participants with AEs leading to discontinuation of study treatment
timeFrame: Up to 3 years
measure: Proportion of participants with laboratory abnormalities
timeFrame: Up to 40 months
measure: Proportion of participants with vital sign abnormalities
timeFrame: Up to 40 months
measure: Proportion of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 40 months
measure: Proportion of participants with physical examination abnormalities
timeFrame: Up to 40 months
measure: Proportion of participants with serious or opportunistic infections
timeFrame: Up to 40 months
measure: Proportion of participants with malignancy
timeFrame: Up to 40 months
measure: Proportion of participants with bradycardia and heart condition abnormalities
timeFrame: Up to 40 months
measure: Proportion of participants with pulmonary toxicity
timeFrame: Up to 40 months
measure: Proportion of participants with macular edema
timeFrame: Up to 40 months
measure: Proportion of participants with hepatotoxicity
timeFrame: Up to 40 months
measure: Proportion of participants with posterior reversible encephalopathy syndrome
timeFrame: Up to 40 months
measure: Proportion of participants with progressive multifocal leukoencephalopathy
timeFrame: Up to 40 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0002
state: Beijing
city: Guangzhou
country: China
facility: Local Institution - 0012
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0022
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 0008
state: Guangdong
city: Shijiazhuang
country: China
facility: Local Institution - 0004
state: Hebei
city: Harbin
country: China
facility: Local Institution - 0006
state: Heilongjiang
city: Zhengzhou
country: China
facility: Local Institution - 0018
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0007
state: Hubei
city: Nanchang
country: China
facility: Local Institution - 0003
state: Jiangxi
city: Changchun
country: China
facility: Local Institution - 0005
state: Jilin
city: Taiyuan
country: China
facility: Local Institution - 0015
state: Shan1xi
city: Urumqi
country: China
facility: Local Institution - 0023
state: Shan1xi
city: Shanghai
country: China
facility: Local Institution - 0016
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0011
state: Sichuan
city: Kunming
country: China
facility: Local Institution - 0024
state: Yunnan
city: Hangzhou
country: China
facility: Local Institution - 0019
state: Zhejiang
city: Wenzhou
country: China
facility: Local Institution - 0017
state: Zhejiang
city: Beijing
country: China
facility: Local Institution - 0009
city: Fuzhou
country: China
facility: Local Institution - 0025
city: Guiyang
country: China
facility: Local Institution - 0010
city: Hohhot
country: China
facility: Local Institution - 0013
city: Shanghai
country: China
facility: Local Institution - 0014
city: Shenyang
country: China
facility: Local Institution - 0021
city: Tianjin
country: China
facility: Local Institution - 0001
city: Xianyang
country: China
facility: Local Institution - 0020
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: