SM101 in Lupus Erythematosus (SMILE)

• Research type

  Research Study

• Full title

  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 Fcgammareceptor IIb (SM101) for intravenous application in thetreatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis

• IRAS ID

  83241

• Contact name

  David D'Cruz

• Sponsor organisation

  SuppreMol GmbH

• Eudract number

  2010-023396-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study investigates a new treatment for preventing and/ or ameliorating systemic lupus erythematosus (SLE) in patients with or without a history of lupus nephritis. The main purpose of this study is to find a dose of the study drug that's safe and effective in the treatment of SLE.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/1095

• Date of REC Opinion

  22 Sep 2011

• REC opinion

  Further Information Favourable Opinion