2 different doses of crizanlizumab vs placebo in SCD patients

• Research type

  Research Study

• Full title

  Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab versus placebo, with or without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Vaso-Occlusive Crises (STAND)

• IRAS ID

  263922

• Contact name

  Martin Besser

• Contact email

  martin.besser@nhs.net

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2017-001746-10

• Clinicaltrials.gov Identifier

  NCT03814746

• Duration of Study in the UK

  8 years, 4 months, 8 days

• Research summary

  Sickle cell disease (SCD) is a rare blood disorder that can lead to serious acute and long-term complications. This disease can lead to episodes of severe acute pain from blocked blood vessels with sickle cells, which is also called as vaso-occlusive crises (VOC).
  This research study is looking at the effectiveness of a new medicine in people who have Sickle Cell Disease. Patients will receive crizanlizumab / placebo.

  The purpose of this study is to confirm the best dose of crizanlizumab. Five (5.0) mg/kg has shown to be beneficial to reduce the number of vaso occlusive crisis VOCs leading to healthcare visits. A higher dose (7.5 mg/kg) could have greater benefits. Both doses will be compared to placebo, an inactive substance administered in the same way as crizanlizumab. A placebo is used to make sure that the changes reported are not happening by chance.
  We expect that about 11 patients in 6 different hospitals will be enrolled in this study in the UK.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  19/LO/0891

• Date of REC Opinion

  8 Jul 2019

• REC opinion

  Further Information Favourable Opinion