Clinical Trial Goal
To find out if crizanlizumab is safe and works well to treat SCD in children and adults
You may be able to join this trial if you:
- Are 12 years old or older
- Have SCD
- Have had 4-12 pain crises in the last year
- Have not had a blood or marrow transplant (BMT)
- Have not had gene therapy
- Have not had a stroke or brain bleed in the last year
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Crizanlizumab is a monoclonal antibody that targets P-selectin on certain cells. It is used to reduce the number of pain crises.
Everyone in this trial will get hydroxyurea if needed and standard drugs to treat pain.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
Everyone in this trial will get hydroxyurea if needed and standard drugs to treat pain.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – Crizanlizumab
- Group 2 – Placebo
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- Crizanlizumab – Group 1 only - Given as an intravenous (IV) infusion
The clinical trial doctors will check your health for 2 years.
The Food and Drug Administration (FDA) has approved crizanlizumab for the treatment of SCD in patients 16 years old or older.
Contacts
Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com
Novartis Pharmaceuticals, +41613241111
Locations
Sponsors
lead: Novartis Pharmaceuticals
