Clinical Trial Goal
To find out:
- The highest dose of ITU512 that's safe to give
- If ITU512 is safe and works well to treat SCD in children, teens and adults
You may be able to join this trial if you:
- Are 12 - 55 years old
- Have SCD
- Are currently being treated with hydroxyurea
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
ITU512 is a molecular glue degrader that targets WIZ, and increases fetal hemoglobin (HbF).
Everyone in this trial will get 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 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 – ITU512
- 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:
- ITU512 – Group 1 only - The dose you'll get depends on when you start the trial and how safe it has been
- Placebo – Group 2 only - A pill with no medicine in it that you take by mouth 1 time each day
The clinical trial doctors will check your health for up to 4 months.
The Food and Drug Administration (FDA) has not yet approved ITU512.
Contacts
Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com
Novartis Pharmaceuticals, +41613241111
Locations
University of Alabama BirminghamRECRUITING
Birmingham, Alabama
Emily Burke, 205-975-4020, eduke@uabmc.edu
Quotient Sciences Sea ViewCOMPLETED
Miami, Florida
Boston Childrens HospitalRECRUITING
Boston, Massachusetts
Nadia Tarhini, 617-355-4278, nadia.tarhini@childrens.harvard.edu
Sponsors
lead: Novartis Pharmaceuticals
