A MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND PHASE III CLINICAL TRIAL OF OBINUTUZUMAB IN PATIENTS WITH ACTIVE LUPUS NEPHRITIS

Tanaka Yoshiya0 个研究点目标入组 24 人开始时间: 2021年12月25日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•(1)Patients living in Japan aged 18-75 years
•(2)Active Class III or IV or III/IV+V LN (not including Class III(C),IV(C))diagnosed according to ISN/RPS 2003 Classification Criteria by renal biopsy performed in the 6 months prior to ICF or during screening
•(3)SLE according to the EULAR/ACR 2019 Classification Criteria, which are met by the presence of Class III or IV LN refer to (2) and positive antinuclear antibody status at the time of screening or in previous examinations
•(4)UPCR >= 1 on a 24-hour collection
•(5)Patient who receipt of at least one dose of steroid pulse therapy (methylprednisolone >= 250 mg or equivalent) for treatment to active LN within 6 months prior to screening or during screening (until prior to Day 1 obinutuzumab or placebo)
•(6)For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception, and agreement to refrain from ovum donation (18 months after the final dose of obinutuzumab or placebo and 6 weeks after the final dose of MMF)
•(7)For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm(90 days after the final dose of MMF)

•(1)eGFR<30 mL/min/1.73 m2(eGFR creat equation)or Severe renal impairment patient who need for dialysis or renal transplantation
•(2)Sclerosis in > 50% of glomeruli
•(3)Presence of rapidly progressive glomerulonephritis, defined by any of the following:
•-Crescent formation in >= 50% of glomeruli assessed
•-Sustained doubling of the serum creatinine reference range within 2 months prior to screening
•(4)Rapidly progressive glomerulonephritis as determined by the investigator
•(5)Central nervous system lupus
•(6)Any biologic agents that deplete B cells or plasma cells (Anti-CD 19 antibody, anti-CD 20 antibody, etc) within 9 months prior to screening or during screening.
•(7)Calcineurin inhibitors within 4 weeks prior to screening or during screening
•(8)Cyclophosphamides within 2 months prior to screening or during screening
•(9)Any biologic therapy (drugs other than B cell or plasma cell depleting drugs that may affect the safety of subjects or evaluation of this study) within 2 months prior to screening or during screening
•(10)Oral inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2) or any investigational agent within 2 months prior to screening or during screening
•(11)Any live vaccine within 27 days prior to screening or during screening

发起方

Tanaka Yoshiya