This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 284 weeks.
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.
A phase-3, randomized, dose-blind, substudy is added in this extension study for all participants who have been enrolled in the 230LE306 Phase 3 LTE study for a minimum of 4 months and have at least four remaining visits in the Phase 3 LTE study.
The primary objective of this substudy is to evaluate the safety of injector device used for administering litifilimab in participants with active SLE.
The secondary objective of this substudy is to evaluate the tolerability of injector device used for administering litifilimab in participants with active SLE.
