A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
This Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study with OLE is to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 142 weeks, including screening and follow-up. Double-blind period will be 76 weeks. Participants who complete double-blind treatment period may enter open-label extension to receive anifrolumab for up 52 weeks. Approximately 360 of the enrolled participants will be randomly assigned to study intervention (anifrolumab or placebo) at a ratio of 1:1 during double-blind treatment period.
Inclusion Criteria:
Exclusion Criteria:
CABA, C1425EOE, Argentina
Ciudad de Buenos Aires, C1015ABO, Argentina
Mainz Am Rhein, 55131, Germany
Visakapatnam, 530013, India
Kita-gun, 761-0793, Japan
Kitakyushu-shi, 807-8555, Japan
Matsumoto-shi, 390-8621, Japan
Sagamihara-shi, 252-0375, Japan
Shinagawa-ku, 142-0054, Japan
Shinjuku-ku, 160-8582, Japan
Shinjuku-ku, 162-8655, Japan
Shinjuku-ku, 162-8666, Japan
Toyoake-shi, 470-1192, Japan
Muang, 50200, Thailand
Hochiminh, 70000, Vietnam