Psoriasis (sor-EYE-uh-sus) is a skin condition that causes areas of red, flaky skin called plaques (plaxs). The plaques may get better, then worse, and may go away and come back again in the same or different part of the body. It can appear anywhere on the body but is most commonly found on the scalp, knees, elbows, and torso. Psoriasis is an auto-immune disease, and there is no cure.
While doctors are getting better at understanding who gets psoriasis (via genetics, for example) more work remains to fully understand the disease. Doctors do however know that it starts with the immune system. We all have immune cells in our body that help fight off bacteria and viruses that make us sick. When these immune cells attack healthy skin cells by mistake, we have psoriasis. The body responds by telling the skin cells to make more cells that build up on the surface of the skin.
Currently, there is no cure for plaque psoriasis and there are few treatment options for children who have it. Clinical research studies are needed to learn about new medicines that may be able to help. If you have a child that is between 6 and 17 years of age who has plaque psoriasis, you may want to consider a clinical research study that is investigating a potential new treatment option.
Taking Part in the SPROUT Research Study
Every year, thousands of adults and children take part in clinical research studies to help discover new medicines to treat diseases. Clinical research studies are needed to learn whether these medicines work and are safe.
Apremilast (ah-prem-il-last) was approved for adults with moderate to severe plaque psoriasis in 2014 and has been used by adults in the United States and other countries around the world.
SPROUT is the second clinical research study of apremilast in children with moderate to severe plaque psoriasis. Children who complete the SPROUT research study may be eligible to continue receiving apremilast for up to 4 years as part of a separate long-term study. Apremilast has not been approved for use in children.
The SPROUT research study will help doctors learn whether apremilast can be used safely and effectively in children who have moderate to severe plaque psoriasis.
What Is the Study Medicine?
Apremilast works with the body’s immune system to help control inflammation of the skin. It is a tablet that is taken by mouth 2 times a day with water or food.
In this study, apremilast will be compared to a placebo. A placebo is a tablet that looks like apremilast, but it does not contain active medicine. It is used to help determine whether apremilast works.
As with any medicine, apremilast may have side effects. As an investigational medicine for children, not all the side effects may be known at this time. Side effects may include*:
• stomach upset and/or pain
• frequent bowel movements
• feeling tired
*There may be other unknown side effects and risks.
How Many Children Will Take Part in the Study?
At least 230 children 6 to 17 years of age will take part in the study in North America, Europe, Israel and Russia.