EUCTR2010-023396-25-BE进行中（未招募）1 期
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
- 1 期
- 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 years or older
- •3. Patients with a body weight equal to or greater than 40 kg and less than or equal to 100 kg
- •4. Diagnosis of SLE meeting at least four revised main classification criteria of the ACR
- •5. Clinically active patients with a Safety of Estrogen in Lupus Erythematosus National
- •Assessment version of the Systemic Lupus Erythematosus Disease Activity Index
- •(SELENA-SLEDAI) score of equal to or greater than 6 within 8 weeks preceding the first dose of investigational product. A subpopulation will fulfil the additional criterion of lupus nephritis:
- •History of class III, IV, V or a combination, excluding pure class V
- •glomerulonephritis confirmed by renal biopsy according to the International
- •Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification within
- •36 months preceding the first dose of investigational product.
- •6. Patients with a current serological active status defined as an increased serum anti-dsDNA > 25% by Farr assay or above the upper limit of normal (ULN) [SELENA-SLEDAI score = 2] and/or a decrease in C3 and below lower limit of normal (LLN) [SELENA-SLEDAI score = 2]. Abnormality will be confirmed by a central laboratory from a serum sample taken within 3 weeks preceeding the first dose of investigational product
- •7. Patient has completed immunosuppressant SLE treatment (if any) for active
- •glomerulonephritis or major organ involvement with cyclophosphamide, MMF, AZA,
- •methotrexate, cyclosporine, etc., other than listed in inclusion criterion No. 8, within
- •8 weeks preceding the first dose of investigational product administration
- •8. Concurrent maintenance immunosuppressant SLE treatment (if any) with less than or equal to 20 mg/day prednisone (or equivalent) alone or in combination with either less than or equal to 2 mg/kg/day AZA or less than or equal to 2 g/day MMF has been stable for 4 weeks preceding the first dose of investigational product and is intended to remain stable within 4 weeks after first dose of investigational
- •9. Concurrent adjuvant maintenance SLE treatment (if any) such as antimalarials,
- •angiotesnin-converting enzyme (ACE) inhibitors, NSAIDs, cyclooxygenase inhibitors,
- •anticoagulation- and antiplatelet agents, hormone replacement therapy, etc., has been stable for 4 weeks preceding the first dose of investigational product and is intended to remain stable within 4 weeks after first dose of investigational product
- •10. Women of childbearing potential must have a negative serum pregnancy test within 3 weeks preceding the first dose of investigational product and a negative urine pregnancy test on study Day 1
- •11. Both women of childbearing potential and men must use a medically acceptable method of contraception prior to inclusion, throughout the study, and within
- •4 weeks after investigational product discontinuation
- •12. Adequate liver function expressed as:
- •a) Aspartate aminotransferase (AST) less than or equal to 3 times ULN and
- •b) Alanine aminotransferase (ALT) less than or equal to 3 times ULN and
- •c) Serum bilirubin less than or equal to 3 times ULN
- •13. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2, with a life expectancy of at least 9 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for
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. Patient is intended to receive immunosuppressive SLE treatment other than listed in inclusion criterion No. 8 within 4 weeks after first dose of investigational product
- •3. Patients with proteinuria > 3.5 g/day at baseline or glomerular filtration rate (GFR)
- •< 60 mL/min/1.73 m2
- •4. Patients with active SLE neurological disorders as described in Section 8 of the revised ACR SLE criteria within 12 weeks preceding the first dose of investigational product
- •5. Patients with a BILAG score defined as equal to or greater than 1 BILAG A score or equal to or greater than 2 BILAG B scores within 8 weeks preceding the first dose of investigational product
- •6. History of class VI glomerulonephritis
- •7. Patients with non-lupus related renal disease such as microthrombotic disease associated with antiphospholipid syndrome
- •8. Patients with known retroviral infection such as human immunodeficiency virus (HIV), hepatitis B or C
- •9. Patients with other acute infections within 4 weeks preceding the first dose of
- •investigational product
- •10. Patient received intravenous immunoglobulins (IVIGs) treatment within 12 weeks
- •preceding the first dose of investigational product
- •11. Patient received any B cell depleting therapy (e.g. Rituximab) within 48 weeks preceding the first dose of investigational product
- •12. Any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with all study procedures
- •13. Known hypersensitivity to any recombinant E. coli-derived product or investigational product excipients (Polysorbat 20, Mannitol, Sucrose)
- •14. Patients participating in a concurrent clinical trial or treated with another investigational product within 4 weeks or five terminal half-lives (whichever is longer) preceding the first dose of investigational product
- •15. History of alcohol or drug abuse within the previous 5 years
- •16. Any condition which in the judgment of the Investigator would place the patient at undue risk or interfere with the results of the study
- •17. Patients with an active malignancy
- •18. Patients with active, serious, life-threatening disease with a life expectancy of less than 9 months
研究者
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