Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Korábbi kezelés

• A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
• 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).
• Previous receipt of >◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.

Más betegség

• Evidence of hepatitis C or active hepatitis B.
• Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
• Any history of severe COVID-19 infection.

Laborértékek

• 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 > 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.

Egyéb

• Known intolerance to ≤ 1.0 g/day of MMF.

• Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
• Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
• Urine protein to creatinine ratio > 1 mg/mg (113.17 mg/mmol)
• eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
• Fulfills updated 2019 EULAR/ACR SLE classification criteria.
• No signs of symptoms of active TB prior to or during screening or no treatment for latent TB