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Novartis Lupus Nephritis

Title A two-year, phase III randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis
Therapeutic Area Lupus
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 18 Years
Max Age 75 Years
Gender All
Contact Vivian Deng
More Information


The purpose of the study is to evaluate the ability and safety of subcutaneous secukinumab 300 mg plus standard of care, compared to placebo plus standard of care, in treating subjects with active Lupus Nephritis.

Study Details

Inclusion Criteria

  • Confirmed diagnosis of lupus
  • Currently on, or willing to initiate standard of care induction therapy for lupus nephritis
  • Must be treated with anti-malarials (e.g. hydroxychloroquine)

Exclusion Criteria

  • Severe renal impairment
  • Received any other biologic immunomodulatory therapy within 6 months
  • Previous exposure to secukinumab and other biologic drug targeting IL-17 or Il-17 receptor

Study Requirements

Your study participation will last for about a maximum of 122 weeks depending on the time spent in screening period of the study (approximately 2 years 5 months including 6 weeks of screening, 104 weeks of study drug dosing and 12 weeks of follow-up).


This will include hospital/clinical visits, physical examinations, and taking blood and urine samples.


You will be asked to come to the doctor’s office/clinic/study site for maximum of 37 times over about 122 weeks /30 months /2.5 years. Each visit should take approximately about 2 to 4 hours, depending on the assessments to be performed at each visit.