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Placebo + fingolimod refers to the treatment arms evaluated in a Phase 3 clinical trial (NCT01941004) sponsored by Novartis, which focused on the efficacy and safety of fingolimod in Chinese patients with relapsing-remitting multiple sclerosis (RRMS). Fingolimod (Gilenya) is a small molecule sphingosine-1-phosphate (S1P) receptor modulator and was the first oral disease-modifying therapy approved for multiple sclerosis. It acts as a functional antagonist by binding to S1P receptors on lymphocytes, leading to receptor internalization and preventing the egress of lymphocytes from lymph nodes. This sequestration reduces the infiltration of auto-reactive lymphocytes into the central nervous system, thereby mitigating neuroinflammation and axonal damage. The trial compared a 0.5 mg daily oral dose of fingolimod against a placebo control over a 12-month period, supporting its approval in China in 2019.
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