PER-021-21招募中3 期
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry:
- •- Participants who are capable of giving signed informed consent
- •- Participants who are age 18-75 years at the time of signing Informed Consent Form
- •- Ability to comply with the study protocol, in the investigator's judgment
- •- Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria
- •- 12 weeks prior to screening.
- •- ANA >= 1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
- •- Low C3, C4, and/or CH50 as determined by the central laboratory at screening
- •- High disease activity at screening
- •- High disease activity on Day 1,
- •- Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: OCS, antimalarials, conventional immunosuppressants
排除标准
- •- Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo
- •- Presence of significant lupus-associated renal disease and/or renal impairment
- •- Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator
- •- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
- •- Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening
- •- History of non-SLE inflammatory skin or joint disease within one year of Day 1 that, in the opinion of the investigator, could interfere with assessments of skin or joint manifestations of SLE
- •- History of any non-SLE disease treated with oral, IV, or IM corticosteroids for more than 14 days in total during the one year prior to Day 1
- •- Receipt of any of the following excluded therapies: Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy, Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening, Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell), Inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), Any live vaccine during the 28 days prior to screening.
- •- High risk for clinically significant bleeding
- •- Significant or uncontrolled medical disease
- •- HIV infection
- •- Tuberculosis (TB) infection
- •- Active infection of any kind, excluding fungal infection of the nail beds
- •- Any major episode of infection
- •- History of serious recurrent or chronic infection
- •- History of progressive multifocal leukoencephalopathy (PML)
- •- History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
- •- Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening
- •- Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening
- •- Intolerance or contraindication to study therapies
- •- Any of the following laboratory parameters (AST or ALT >2.5xULN, Neutrophils <1.5x103/µL, positive hepatitis B surface antigen (HBsAg, positive hepatitis C serology, Hemoglobin < 7 g/dL, unless due to active to SLE, platelet count <50,000/µL, unless due to active SLE)
研究者
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