LUMIOS - A Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy, safety and tolerability of cenerimod in adult patients with systemic lupus erythematosus and active lupus nephritis in combination with background therapy

Condition studied

Systemic lupus erythematosus and active lupus nephritis

Investigational medicinal product(s)

Eligibility

Primary endpoint

CRR at Week 76, defined as (both must be met): • Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND • No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)

Endpoint detail

CRR at Week 76 with oral daily dose of 5 mg/day prednisone equivalent or less from Week 24 onwards, Sustained CRR at Week 76. Sustained CRR is defined as participant meeting CRR criteria for two consecutive visits (i.e., 3 months apart) and confirmed at Week 76 visit. The second consecutive visit can be the Week 76 visit to qualify as sustained CRR