The efficacy and safety of dapirolizumab pegol in active lupus (SLE)

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

• IRAS ID

  1003032

• Contact name

  David D'Cruz

• Contact email

  david.dcruz@gstt.nhs.uk

• Eudract number

  2019-003406-27

• Clinicaltrials.gov Identifier

  NCT04596995

• Research summary

  Summary of Research
  Systemic lupus erythematosus (SLE) is a long-term (chronic) disease that leads to
  inflammation in the body that’s caused by the body’s immune system attacking its own
  healthy organs. Although some patients have active symptoms all the time, it often has a
  relapsing-remitting effect meaning the symptoms are at times worse (in relapse) and
  other times are improved or gone (in remission).
  With current treatments for SLE, the majority of patients develop tissue and organ
  damage over time due to a lack of being able to control disease activity, or due to
  harmful side effects of the medications.
  The aim of this study is to see if the investigational drug (not approved for sale)
  dapirolizumab pegol (DZP), when used in addition to current SLE medication, can
  improve the disease over a period of 48 weeks, for patients with both active and
  frequently relapsed-remitting SLE. The effectiveness of DZP will be compared against a
  placebo (study drug that contains no medicinal ingredient).
  DZP is a type of molecule called an antibody. They help the immune system to fight
  infections by attaching to foreign molecules in the body called antigens. DZP attaches to
  molecules called CD40 ligand (CD40L) found of the surface of certain cells that are
  involved in communication within the immune system. By doing this, it stops the
  communication and therefore stops the inflammation in the body.
  DZP is a liquid drug that will be given intravenously (in a vein). Evidence from previous
  studies has shown that DZP, when used in combination with standard medications, is
  more effective than using standard medications alone in patients with active or relapsedremitting
  SLE.
  The study will include approximately 450 participants across approximately 280 sites in
  around 31 countries worldwide. This research is being sponsored by UCB Biopharma
  SRL.

  Summary of Results
  N/A

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  20/ES/0067

• Date of REC Opinion

  9 Sep 2020

• REC opinion

  Further Information Favourable Opinion