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

• Status: Recruiting
• Trial end date: 2024-12-28
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of 0.5mg Fingolimod (Gilenya) in Chinese patients with relapsing relapsing multiple sclerosis (RMS)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

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.

Other protocol-specified inclusion or exclusion criteria may apply.