EUCTR2010-018329-20-GB进行中（未招募）不适用
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination with Standard of Care (Mycophenolate Mofetil and Steroids)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
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.Subjects diagnosed with SLE, who fulfilled at least 4 classification criteria of the American College of Rheumatology for SLE by the time of screening visit.
- •2.Kidney biopsy within 12 months prior to baseline with a histological diagnosis of LN.
- •3.Clinically active LN
- •4.Subjects must be between the ages of 18 and 75 years (inclusive).
- •5.Subjects are willing and able to provide a written informed consent.
- •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 this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1.GFR = 30 ml/min/1.73m2 as calculated by MDRD formula at screening visit.
- •2.Dialysis within the last month prior to screening or scheduled to receive dialysis.
- •3.Previous kidney transplant or planned transplant.
- •4.Subjects with hemoglobin < 8.5 g/dl or neutrophils < 1300/ mm3 or platelets < 50,000/mm3 at screening.
- •5.Any previous diagnosis of drug induced lupus.
- •6.Subjects with severe, unstable and/or progressive CNS lupus and/or associated with significant cognitive impairment.
- •7.Subjects with a clinically significant or unstable medical or surgical condition that, in the Investigator’s opinion, would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests or imaging.
- •8.MMF/steroids specific exclusion criteria:
- •Pancreatitis within 6 months prior to screening.
- •Gastrointestinal hemorrhage within 6 months prior to screening.
- •Peptic ulcers (unhealed) within 3 months prior to screening
- •Subject weight > 120kg (265 pound).
- •9.Subjects with a = 2.5x upper limit of normal (ULN) serum elevation of either ALT or AST at screening.
- •10.Subjects with a = 2x upper limit of normal direct or total bilirubin at screening.
- •11.Subjects diagnosed with Diabetes Mellitus, or Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Vasculitis.
- •12.Medical condition, other than SLE that requires chronic treatment with immunosuppressive drugs or systemic corticosteroids (not including inhaled steroids).
- •13.Subjects with a history of malignancy within 5 years from screening with the exception of basal cell carcinoma (completely excised).
- •14.Women who are pregnant or nursing at the time of screening, or who intend to be during the study period.
- •15.Women of child-bearing potential who do not practice an acceptable method of birth control.
- •16.Subjects treated with MMF dose = 2 g/day anytime between 31 days and 90 days prior to baseline or MMF dose >2 g/day within 30 days prior to baseline.
- •17.Subjects treated with oral corticosteroids at doses higher than 20 mg/day of prednisolone/prednisone (or equivalent) anytime between 8 and 90 days prior to baseline or prednisolone/prednisone dose (or equivalent) >40 mg/day within 7 days prior to baseline or any IV or IM steroid dose within 90 days prior to baseline.
- •18.Subjects treated with Azathioprine, MTX, Cyclosporine or Tacrolimus within 2 weeks prior to baseline.
- •19.Subjects treated with cyclophosphamide within 12 weeks prior to screening.
- •20.Subjects treated with Rituximab, abatacept, intravenous immune globulin (IV Ig), plasmapheresis or any other biologic therapy within 24 weeks prior to screening.
- •21.Subjects treated with alkylating agents (other than cyclophosphamide such as: nitrogen mustard, chlorambucil, vincristine, procarbazine or etopside) within 52 weeks prior to screening.
- •22.Subjects who received any investigational medication within 24 weeks prior to screening.
- •23.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine).
- •24.Use of amiodarone within 2 years prior to screening visit.
- •25.Subjects treated with sevelamer, acyclovir, valacyclovir, ganciclovir,
- •rifampin, antacids that contain magnesium and aluminium hydroxide,
- •norfloxacin, metronidazole or cholestyramine at screening or baseline.
- •26.A known drug hypersensitivity that would preclude administration of study medications, such as known hypersensitivity to MMF, corticosteroids or hypersensitivity to: mannitol, megl
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