BO42452-A Study in Sickle Cell Disease

• Research type

  Research Study

• Full title

  A PHASE IB RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB FOR THE MANAGEMENT OF ACUTE UNCOMPLICATED VASO-OCCLUSIVE EPISODES (VOE) IN PATIENTS WITH SICKLE CELL DISEASE (SCD)

• IRAS ID

  1005134

• Contact name

  Ramneet Jagdev

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F.Hoffmann-La Roche Ltd

• Eudract number

  2020-004840-27

• ISRCTN Number

  ISRCTN89975936

• Research summary

  Sickle cell disease (SDC) is a disorder of the structure of haemoglobin found in red blood cells and is a serious lifelong condition. Although treatment and survival of SCD has improved, there is still a need to improve treatments for people living with SCD particularly in the acute setting (i.e sudden onset of pain).

  Crovalimab is a new experimental drug which may help to decrease inflammation and destruction of your red blood cells, and may improve episodes of pain attack (crisis).

  The purpose of this study is to compare the effects, good and bad, of crovalimab versus placebo on participants aged between 12- 55 years old with SCD experiencing a pain attack.

  In this study, a participant will receive either crovalimab or placebo. A placebo looks like a drug but has no active ingredient. The treatment group is decided by chance, using a computer program. Neither the participant nor the study staff can choose or know which treatment group is allocated.

  The study has 3 stages:
  - Screening: to see if the patient is eligible for the study
  - Treatment: a single dose of Crovalimab or Placebo, followed by hospitalisation up to 14 days to manage the pain attack
  - Follow-Up visits / telephones calls to check on the participant’s response and their health

  The total time in the study will be about 12 weeks or 84 days, which includes the treatment, the time the patient is hospitalised for the pain attack (crisis) and the post-discharge follow-up visits.

  Approximately 30 participants will take part in this study globally including 4 participants from 2 hospitals in England.

  The study is sponsored by F. Hoffmann-La Roche Ltd
  Research Summary; V 1.0, 15-Feb-2022

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  22/EE/0060

• Date of REC Opinion

  23 May 2022

• REC opinion

  Further Information Favourable Opinion