Placebo-Controlled Study–Systemic Lupus Erythematosus

• Research type

  Research Study

• Full title

  A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

• IRAS ID

  204158

• Contact name

  David D'Cruz

• Contact email

  david.d'cruz@kcl.ac.uk

• Sponsor organisation

  ImmuPharma SA

• Eudract number

  2015-003341-25

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Systemic lupus erythematosus (SLE) is a polygenic autoimmune disease. Current treatments for patients with SLE are based primarily on corticosteroids and immunosuppressive drugs which are often administered at high doses and can have numerous adverse effects.
  The purpose of this study is to evaluate the effectiveness and safety of the study drug, in patients with systemic lupus erythematosus. This study drug is compared to placebo, given every 4 weeks for up to 48 weeks, for a maximum of 13 doses to observe improvement in overall disease activity in subjects with active SLE.
  Approximately 200 patients will participate in this study, which will be taking place in 35 sites in Europe and 10 sites in United states of America.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  16/LO/1334

• Date of REC Opinion

  17 Oct 2016

• REC opinion

  Further Information Favourable Opinion