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

Novartis

Status and phase

Completed

Phase 4

Conditions

Relapsing Multiple Sclerosis (RMS)

Treatments

Drug: Fingolimod 0.5mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04667949

CFTY720D2419

2024-000601-32 (EudraCT Number)

Details and patient eligibility

About

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)

Full 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.

Enrollment

98 patients

Sex

All

Ages

10 to 65 years old

Volunteers

No Healthy Volunteers

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.