EUCTR2010-023396-25-CZ进行中（未招募）不适用
Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient has provided written informed consent prior to any study-related procedure
- •2.Male or female adult patients aged 18 to 65 years
- •3.Patients with a body weight between = 40 kg and = 100 kg
- •4.At least 4 criteria of the American College of Rheumatology (ACR) revised criteria (APPENDIX 1) documented in the medical history
- •5.A SELENA-SLEDAI score of at least 6 within 8 weeks prior to the first IP dosing.
- •A subpopulation will fulfil in addition the following criteria for lupus nephritis:
- •a) A history of class III, IV, or a combination of these with class V glomerulonephritis, within 60 months prior to first IP
- •dosing confirmed by a renal biopsy according to the International Society of Nephrology (ISN) and the Renal Pathology Society (RPS) [APPENDIX 2].
- •The patient had never a pure class V or VI glomerulonephritisduring the disease course
- •b) Proteinuria between > 0.2 to = 3.5 g/day at SCR
- •6.Patients with a present serological active status defined as abnormal laboratory values from the last 2 local serum samples for the following parameters:
- •a) serum antibodies against double-stranded DNA (anti-dsDNA) above upper limit of normal (ULN)
- •b) complement component 3 (C3) below lower limit of normal (LLN)
- •Abnormality will be confirmed by a central laboratory during screening.
- •7.Patients with immunosuppressant SLE treatment (if any) other than listed under 8. have completed their SLE therapy prior to first IP dosing as follows:
- •a) B-cell depleting agents (e.g. rituximab, epratuzumab, etc.) for = 48 weeks
- •b) B-cell modifying agents (e.g. belimumab, atacicept, etc.) for = 24 weeks
- •c) Intravenous immunoglobulins (IVIGs) for = 12 weeks
- •d) All other immunosuppressive SLE treatment (e.g. metho-trexate, cyclophosphamide, cyclosporine, tacrolimus, etc.) for = 8 weeks
- •8.Patients with a stable maintenance immunosuppressant SLE treatment (if any) within 4 weeks prior to first IP dosing consisting of:
- •= 20 mg/day prednisone (or equivalent)
- •alone or in combination with either
- •a) = 2 mg/kg/day azathioprine (AZA)
- •b) = 2 g/day mycophenolate mofetil (MMF) [or equivalent]
- •9.The maintenance immunosuppressant SLE treatment is intended to remain stable during the clinical trial but at least within 4 weeks after the first IP dosing
- •10.Patients with a stable adjuvant maintenance SLE treatment (if any) such as antimalarias, angotensin-converting enzyme (ACE) inhibitors, non-steroid anti-inflammatory drugs (NSAIDs), cyclooxygenase inhibitors, anticoagulation- and antiplatelet agents, hormone replacement therapy, etc. within 4 weeks prior to first IP dosing. The adjuvant maintenance SLE treatment is intended to remain stable during the clinical trial but at least within 4 weeks after first IP dosing
- •11.Women of childbearing potential must have a negative serum pregnancy test within 3 weeks preceding the first dose of IP and a negative urine pregnancy test on study day 1
- •12.Both women of childbearing potential and men must use a medically acceptable method of contraception
- •(APPENDIX 7) prior to inclusion, throughout the study, and within 12 weeks after IP discontinuation
- •13.Eastern Cooperative Oncology Group (ECOG) performance status = 2, with a life expectancy of at least 9 months (APPENDIX 8)
- •14.X-ray scan performed within 6 months preceding the first dose of investigationl product and negative Quantiferon test at screening visit 1 excluding active and latent tuberculosis
- •Are the trial subjects under 18?
排除标准
- •1.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
- •2.Patients with active SLE neurological disorder documented according to the ACR SLE criteria as listed in APPENDIX 1 within 12 weeks prior to first IP dosing
- •3.Patients with non-lupus related renal diseases or microthrombotic disease associated with antiphospolipid syndrome
- •4.Patients with known active retroviral infection such as as human immunodeficiency virus (HIV), hepatitis B or C
- •5.Patients with other acute infections (except minor infections such as common cold) within 4 weeks prior to first IP dosing
- •6.Patients with a glomerular filtration rate (GFR) of < 45 mL/min/1.73 m2
- •7.Patients with inadequate liver function expressed as at least one of the following:
- •a) Aspartate aminotransferase (AST) > 3 times ULNOR
- •b) Alanine aminotransferase (ALT) > 3 times ULN OR
- •c) Serum bilirubin > 3 times ULN
- •8.Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with all study procedures
- •9.Known hypersensitivity to any recombinant E. coli-derived product or IP excipients (Polysorbat 20, Mannitol, Sucrose)
- •10.Patients participating in a concurrent clinical trial or treated with another IP within 4 weeks or five terminal half-lives (whichever is longer) prior to first IP dosing
- •11.History of alcohol or drug abuse within the previous 5 years
- •12.Any condition which in the judgment of the Investigator would place the patient at undue risk or interfere with the results of the study
- •13.Patients with an active malignancy
- •14.Patients with active, serious, life-threatening diseases
研究者
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