Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

A 24-month, Open-label, Prospective, Multicenter Interventional, Single-arm Study Assessing the Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Relapsing Multiple Sclerosis (RMS) Patients in China

The main purpose of this study was to assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing multiple sclerosis (RMS)

Study Overview

• Status: Completed
• Conditions: Relapsing Multiple Sclerosis (RMS)
• Intervention / Treatment: Drug: Fingolimod 0.5mg

Detailed Description

This was a 24-month, open-label, multicenter, interventional, single-arm study to collect efficacy and, safety of oral fingolimod 0.5 mg/day in approximately 100 relapsing multiple sclerosis (RMS) participants in China.

The study consisted of three Phases:

• Screening (up to 1 month): After signing informed consent, participants entered a Screening Phase to determine eligibility according to inclusion and exclusion criteria.
• Treatment Period (24 months): On visit Day 1, all eligibility criteria were confirmed, including a pre-dose ECG and vital signs. The first dose of study drug was taken in the clinic on Day 1 and the participant was monitored for 6 hours after the first dose administration before discharge. Participants returned to site for evaluation at month 1 and then every three months until the end of treatment up to 24 months.
• Follow Up (2 months): Subjects who completed Treatment Period or discontinued from treatment returned for the Follow-up visit 2 months after the last dose of study drug.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100028
    • Novartis Investigative Site
  • Beijing, China, 065001
    • Novartis Investigative Site
  • Guangzhou, China, 510260
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510623
      • Novartis Investigative Site
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Novartis Investigative Site
  • Jiangsu
    • Suzhou, Jiangsu, China, 215004
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130021
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant 10 to 17 years old inclusive with weight > 40kg.
• Participant 18 to 65 years old inclusive;
• Participants with relapsing multiple sclerosis
• Participants never used fingolimod before enrollment
• Subjects with Expanded Disability Status Scale (EDSS) score of 0 - 6.0 (inclusive) at Screening

Exclusion Criteria:

• Participants with certain cardiovascular conditions and/or findings in the screening ECG.
• Diagnosis of macular edema during screening visit.
• Increased risk for opportunistic infections
• Participants with known active malignancies.
• Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout.
• Participants with severe active infections, active chronic infection.
• Participants with severe liver impairment.
• Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fingolimod; Fingolimod 0.5 mg capsule taken orally once daily	Drug: Fingolimod 0.5mg; Subjects received fingolimod 0.5mg capsule QD up to month 24; Other Names: FTY720

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Annualized Relapse Rate (ARR) in Adult Group	A confirmed relapse is any relapse that is accompanied by an increase of at least 0.5 on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS) as confirmed by the treating physician. The adjusted annualized relapse rate (ARR) was estimated by a negative binomial regression model with log-link function, the cumulative number of confirmed MS relapses per subject as the response variable, number of relapses in the previous two years before enrollment and baseline EDSS as continuous covariates. Natural log of time on study in years was used as the offset variable to account for the varying lengths of subjects' time in the study. The adjusted ARR (i.e.model-based estimate adjusted for covariates) and the corresponding 95% confidence interval were obtained. As per SAP this analysis was only performed for the Adult group. Descriptive data is presented in subsequent OMs.	Baseline to Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE)	An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject after providing written informed consent for participation in the study. For reporting purposes, the main focus was on treatment emergent adverse event (TEAE), defined as any AE which started on or after the day of first dose of study medication or events present prior to the start of treatment but increased in severity.	From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months
Annualized Rate of the Number of New or Newly Enlarged T2 Lesions	Obtained from fitting a negative binomial regression model with log-link function, the total number of new or newly enlarged T2 lesions during the treatment period (per participant) as the response variable. The model included baseline age and volume of T2 lesions at baseline as continuous covariates. Natural log of time from screening scan in years was used as the offset. Baseline is defined as the last non-missing assessment obtained prior to the first administration of study drug. As per SAP this analysis was only performed for the Adult group.	Baseline to end of treatment (up to Month 24)
Change From Baseline in Number of New or Newly Enlarged T2 Lesions	Number of new/newly enlarged T2 lesions since baseline as measured by MRI	Baseline up to Month 24
Change From Baseline in T2 Lesion Volume	T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value	Baseline up to Month 24
Number of Gd-enhancing T1 Lesions Per Scan in Adult Group	Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per patient) as the response variable. The model included baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans was used as the offset. MRI scans were performed at baseline, month 12 and month 24 and End of treatment for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. As per SAP this analysis was only performed for the Adult group.	Baseline up to Month 24
Number of Gd-enhancing T1 Lesions	Number of Gd-enhancing T1 lesions as measured by MRI	Baseline up to Month 24
Change From Baseline in Gd-enhancing T1 Lesion Volume	Gd-enhancing T1 lesion volume as measured by MRI and calculated as post-baseline value - baseline value	Baseline up to Month 24
Number of T1 Hypo-intense Lesions	Number of T1 hypo-intense lesions as measured by MRI	Baseline up to Month 24
Change From Baseline in T1 Hypo-intense Lesion Volume	T1 hypo-intense lesions as measured by MRI and calculated as post-baseline value - baseline value	Baseline up to Month 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Pediatric Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: China; Pediatric; Adult; Fingolimod; Relapsing Multiple Sclerosis (RMS)
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Organic Chemicals; Amines; Alcohols; Glycols; Amino Alcohols; Sphingosine; Propylene Glycols; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2419; 2024-000601-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No