Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE - SM101 in Lupus Erythematosus

SuppreMol GmbH0 个研究点目标入组 50 人开始时间: 2011年9月2日最近更新: 2024年8月19日

研究概览

暂无简介。

•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. Diagnosis of SLE meeting at least four revised main classification criteria of the ACR with or without a history of glomerulonephritis
•4. Clinically active patients with a SELENA-SLEDAI score of = 6
•5. Patients with a current serological active status (anti-dsDNA or C3)
•6. Concurrent maintenance immunosuppressant SLE treatment (if any) with prednisone alone or in combination with either azathioprine or mycophenolate mofetil
•7. Adequate liver function

•1. Patient is intended to receive immunosuppressive SLE treatment other than listed in the inclusion criteria
•2. Patients with proteinuria > 3.5 g/day at baseline or glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
•3. Patients with active SLE neurological disorders
•4. Patients with an acute BILAG score defined as = 1 BILAG A score or = 2 BILAG B scores
•5. History of class VI glomerulonephritis
•6. Patients with non-lupus related renal disease such as microthrombotic disease associated with antiphospholipid syndrome
•7. Patients with other acute infections
•8. Patient received any B cell depleting therapy

发起方