A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)

Hirano Takamitsu0 个研究点目标入组 24 人开始时间: 2023年2月9日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: >= 12age old 至 ot applicable（—）
性别: All

入选标准

•Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed.
•- Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening
•- Elevated serum titers at screening of anti-nuclear antibodies => 1:80 as determined by a central laboratory with a SLE typical fluorescence pattern.
•- Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol.
•- SLEDAI-2K criteria at screening: SLEDAI-2K score => 6 points, excluding points attributed to 'fever', 'lupus headache', 'alopecia', and 'organic brain syndrome'
•- BILAG-2004 disease activity level at screening of at least 1 of the following:
•- BILAG-2004 level 'A' disease in => 1 organ system,
•- BILAG-2004 level 'B' disease in => 2 organ systems
•- Weigh at least 35 kg at screening

排除标准

•- Prior treatment with ianalumab
•- History of receiving following treatment I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening II) cyclophosphamide or biologics such as immunoglobulins (i.v. or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).
•-Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization or history of recurrent clinically significant infection
•- Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
•- Evidence of active tuberculosis infection
•- History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening
•- Any one of the following abnormal laboratory values prior to randomization
•- Platelets < 25000/ mm^3 (< 25 x 10^3/ micro L)
•- Hemoglobin (Hgb) < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) if related to participant's systemic lupus erythematosus such as in active hemolytic anaemia
•- Absolute neutrophil count (ANC) (< 0.8 x 10^3/ micro L)
•- Severe organ dysfunction or life-threatening disease at screening
•- Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio
•- Receipt of live/attenuated vaccine within a 4-week period before first dosing
•- Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms
•- Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic corticosteroid
•- History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer
•- Pregnant or nursing (lactating) women.
•- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug.
•- Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

研究者

发起方

Hirano Takamitsu

相似试验

进行中（未招募）

不适用

A randomized, double-blind, parallel group, placebo controlled, multi-center study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and tamsulosin hydrochloride OCAS 0.4 mg monotherapy, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component - Neptuneower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasiaLower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

EUCTR2008-001211-37-DEAstellas Pharma Europe B.V.1,452

进行中（未招募）

1 期

Study to investigate the safety of a drug called osocimab at low and high doses in adult patients with kidney failure requiring regular hemodialysisPrevention of thromboembolic events in ESRD patients on hemodialysis who are at risk for thromboembolic eventsMedDRA version: 21.1Level: LLTClassification code 10049910Term: Thromboembolism prophylaxisSystem Organ Class: 100000004865MedDRA version: 21.1Level: LLTClassification code 10066622Term: Chronic hemodialysisSystem Organ Class: 100000004865MedDRA version: 21.0Level: PTClassification code 10077512Term: End stage renal diseaseSystem Organ Class: 10038359 - Renal and urinary disorders

EUCTR2019-003957-27-NLBayer AG750

进行中（未招募）

不适用

A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared with solifenacin succinate monotherapy (3 mg, 6 mg and 9 mg) and tamsulosin OCAS 0.4 mg monotherapy in males with lower urinary tract symptoms - SATURower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasiaMedDRA version: 8.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

EUCTR2006-002072-18-ATAstellas Pharma Europe B.V.840

招募中

3 期

Study of safety, efficacy and tolerability of ianalumab versus placebo, in combination with Standard of care therapy, in participants with active lupus nephritis

CTRI/2023/06/053819ovartis Healthcare Pvt Ltd

进行中（未招募）

1 期

EUCTR2006-002072-18-GBAstellas Pharma Europe B.V.840