Laquinimod in Active Lupus Nephritis Patients

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  50193

• Contact name

  David Jayne

• Sponsor organisation

  Teva Pharmaceuticals Ltd

• Eudract number

  2010-018329-20

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This global study, sponsored by Teva Pharmaceuticals Industries Ltd, will be reviewing how safe, how tolerable, and how effective oral laquinimod is in subjects that have confirmed active lupus nephritis, in combination with a standard of care treatment (mycophenolate mofetil (MMF) and steroids). Systemic Lupus Erythematosus (SLE) is a debilitating autoimmune disease characterized by disorders throughout all arms of the immune system. Lupus nephritis (LN), one of the most serious manifestations of SLE, usually arises early in the disease course, within 5 years of diagnosis. An estimated 30-50% of patients with SLE develop nephritis that requires medical evaluation and treatment. LN is a progressive disease, running a course of clinical exacerbations and remissions. There is currently no definitive treatment or cure for LN and many patients fail to respond, or respond only partially, to the standard of care medications currently used in clinical practice. Laquinimod is an innovative immunomodulator which is currently being developed as an oral formulation for Relapsing Remitting Multiple Sclerosis (RRMS), Crohn??s Disease and SLE. Eligible patients aged between 18 and 75 years with SLE and active Lupus Nephritis (determined by kidney biopsy and severity of proteinuria) will receive either laquinimod (active drug) or placebo (dummy drug). The assignment of which drug the subject will receive will be decided randomly by a computer. Subjects will attend screening and baseline visits, with further visits at weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 and a study completion visit at week 28. All patients will receive MMF and steroids as standard care alongside laquinimod/ placebo. Various study assessments will be performed including physical examinations, blood sampling, urinalysis (urine sample), heart readings, vital signs and assessments of Lupus symptoms. The study will be conducted at hospitals in England and other countries (including Europe and the USA).

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/21

• Date of REC Opinion

  20 May 2010

• REC opinion

  Further Information Favourable Opinion