Lupus Nephritis
Conditions
Interventions
Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab
900 mg IV Q4W for the first 6 doses (Weeks 0 to 20) and 300 mg IV Q4W for the remainder
of the study, or matchin
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification 2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period. 3. Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol) 4. eGFR 35 mL/min/1.73 m2 or more (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula). 5. Fulfills updated 2019 EULAR/ACR SLE classification criteria. 6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB
Exclusion criteria
Exclusion criteria: 1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening. 2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1). 3. Evidence of hepatitis C or active hepatitis B. 4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ. 5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide > 2 pulses of high-dose (0.5 g/m2 or more) or > 4 doses of low dose (500 mg every 2 weeks) or Average MMF > 2.5 g/day (or > 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus > 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF. 6. Previous receipt of >=2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF. 7. Known intolerance to 1.0 g/day of MMF or less. 8. Any history of severe COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in proportion of participants with CRR (Complete Renal Response) in anifrolumab group compared with placebo group [ Time Frame: Week 52 ] CRR is defined as: UPCR 0.5 mg/mg or less eGFR 60 mL/min/1.73 m2 or more, or no decrease from baseline of 20% or more | — |
Countries
Argentina, Belgium, Bulgaria, China, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russian Federation, Taiwan, Thailand, Turkey, United States of America, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed