Lupus Nephritis(LN)
Conditions
Interventions
2 capsules(15.8 mg) , 3 capsules(23.7 mg) or 4 capsules(31.6 mg) of voclosporin administered orally twice daily.
Sponsors
Furukawa Yuichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria. 2. Subjects with kidney biopsy confirmed active lupus nephritis.
Exclusion criteria
Exclusion criteria: 1. Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening. 2. 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. 3. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 4. Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with adjudicated renal response at Week 24 will be defined based on the following parameters: - UPCR of =60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and - Received no rescue medication for LN, and - Did not receive >10 mg/day prednisone for >=3 consecutive days or for >=7 days in total between Week 16 and Week 24. | — |
Countries
Colombia, Japan, Mexico, Thailand, United States
Contacts
Public ContactYuichi Furukawa
Fortrea Japan K.K.
Outcome results
None listed