MedImmune Pharma BV

Evaluating the efficacy and safety of inelizumab in Chinese adult patients with NMOSD

Primary objective: To evaluate the effect of anifrolumab compared with placebo on disease activity based on the difference in the proportion of subjects achieving a BICLA response at week 52. Key secondary objectives: To evaluate the effect of anifrolumab compared with placebo on the following indicators: The proportion of subjects who achieved an OCS dose ≤ 7.5 mg/day at week 40 and maintained it until week 52 in the subgroup of subjects with baseline OCS ≥ 10 mg/day; The proportion of subjects who achieved a ≥ 50% reduction in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score at week 12 in the subgroup of subjects with baseline CLASI activity score ≥ 10; Annualized flare rate within 52 weeks.

The objectives of this study were to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of MEDI3506 after a single subcutaneous administration in healthy Chinese subjects.