Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Eligibility Criteria

• * Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
• * Subjects with kidney biopsy confirmed active lupus nephritis.
• * Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening.
• * Current or medical history of:
• * Congenital or acquired immunodeficiency.
• * Clinically significant drug or alcohol abuse prior to screening.
• * Malignant neoplasm.
• * Lymphoproliferative disease or previous total lymphoid irradiation.
• * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
• * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
• * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• * Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
• * Currently taking or known need for any of the following medications:
• * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.