A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

INTERVENTION: Intervention1: Drug Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1200 mg: Treatment Arm 1 (n equall as 136) IV Sifalimumab (200 mg) for 48 weeks, Treatment Arm 2 (n equall as 136) IV Sifalimumab (600 mg) for 48 weeks, Treatment Arm 3 (n equall as 136) IV Sifalimumab (1200 mg) for 48 weeks Control Intervention1: Placebo: Treatment Arm 4 (n equall 136): IV Placebo for 48 weeks CONDITION: Systemic Lupus Erythematosus PRIMARY OUTCOME: The primary efficacy endpoint for this study is the proportion of subjects achieving a response in an SLE responder index SRI (4) in subjects with chronic, moderately‐to‐severely active SLE‐‐‐‐‐‐Timepoint: At Day 365 (Week 52) SECONDARY OUTCOME: Secondary endpoints include comparison between sifalimumab and placebo groups on the proportion of subjects able to reduce oral corticosteroids doses in subjects on more or equal 10 mg Prednisone equivalent at baseline, ; to improve active inflammatory cutaneous lesions as measured by the CLASI, to reduction in fatigue as measured by the Facit‐Fatigue Scale ; ‐‐‐‐‐‐Timepoint: At Day 365 (Week 52) INCLUSION CRITERIA: Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, one of which must be: a) Significantly positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at central lab; OR b) Elevated anti‐dsDNA or Sm antibody at screening as determined by central lab Disease history of SLE less or equal 24 weeks at screening Weight less than 40 kg Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment Females with an intact cervix must have no evidence of cervical malignancy documented on a Pap smear with 6 months of baseline Females must be willing to avoid pregnancy throughout the study including the 180 day follow‐up safety period

Epistemonikos ID: b35b36ad328509e5f6fe608bd34e9fe860575d0d
First added on: Aug 22, 2024