BO42451
Research type
Research Study
Full title
A RANDOMIZED DOUBLE-BLIND PHASE IIA STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB AS ADJUNCT TREATMENT IN PREVENTION OF VASO-OCCLUSIVE EPISODES (VOE) IN SICKLE CELL DISEASE (SCD)
IRAS ID
1005491
Contact name
Head, EU Product Development Regulatory
Contact email
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2020-004839-25
ISRCTN Number
ISRCTN14514128
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 chronic setting.
Crovalimab is a new experimental drug which may help to decrease inflammation and destruction of 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: of Crovalimab or Placebo, initially given as an infusion into the vein, then as an injection in the skin over a period of 48 weeks
- Follow-up period of 24 weeks to check on the participant’s response and their healthThe total time in the study will be about 1 year and 6 month, which includes the screening, treatment and the follow-up visits.
Approximately 90 participants will take part in this study globally including 6 participants from 3 hospitals in England. The study is sponsored by F. Hoffmann-La RocheVersion 1.0 16/05/2022
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0139
Date of REC Opinion
15 Jul 2022
REC opinion
Further Information Favourable Opinion