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

NCT04667949 | Completed Phase 4 Results

• 2 other identifiers: CFTY720D24192024-000601-32
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 13

Brief Summary

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)

Conditions

Relapsing Multiple Sclerosis (RMS)

Keywords

Relapsing Multiple Sclerosis (RMS); Fingolimod; Adult; Pediatric; China

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE)

  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

  Baseline to end of treatment (up to Month 24)

• Change From Baseline in Number of New or Newly Enlarged T2 Lesions

  Baseline up to Month 24

• Change From Baseline in T2 Lesion Volume

  Baseline up to Month 24

• Number of Gd-enhancing T1 Lesions Per Scan in Adult Group

  Baseline up to Month 24

Study Arms (1)

Fingolimod

EXPERIMENTAL

Fingolimod 0.5 mg capsule taken orally once daily

Drug: Fingolimod 0.5mg

Interventions

Fingolimod 0.5mg DRUG

Subjects received fingolimod 0.5mg capsule QD up to month 24

Also known as: FTY720

Fingolimod

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Beijing, Beijing Municipality, 100000, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510623, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510630, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 450052, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325000, China

Location

Novartis Investigative Site

Beijing, 065001, China

Location

Novartis Investigative Site

Beijing, 100028, China

Location

Novartis Investigative Site

Guangzhou, 510260, China

Location

Novartis Investigative Site

Shanghai, 200040, China

Location

Related Links

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

MeSH Terms

Interventions

Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: February 20, 2021
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: January 13, 2026
• Results First Posted: August 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (13)