Clinical Trial 57309

Valhalla, NY 10595


Summary:

<b>Lupus (Ages 5 to 17) - Multiple Locations in the US</b>

The BLOSSOM trial: A clinical trial for young people aged 5 to 17 with moderate to severe systemic lupus erythematosus (SLE). This is an Autoimmune Trial & You trial.

It is estimated that 1.5 million Americans have lupus, and there are about 16,000 new cases each year. 1 The most common type of lupus is systemic lupus erythematosus (SLE). When SLE happens in young people, doctors call it pediatric systemic lupus erythematosus (pSLE). It typically hits young people harder than adults and carries extra health risks and organ damage. About 15 percent of SLE patients are younger than 18. In the United States, the disease affects an estimated 5,000 to 10,000 young people.2

What is BLOSSOM?

Autoimmune disease like lupus can make life very challenging for young people who are trying to enjoy their childhood to the fullest. BLOSSOM is working to hopefully find new treatments that are better at alleviating the symptoms of SLE in young people.

AstraZeneca understands the impact that autoimmune disease like lupus has on young people who are trying to enjoy their childhood to the fullest. Although there are treatments available for pediatric lupus, AstraZeneca is working on trials such as BLOSSOM to hopefully find new treatments that are better at alleviating the symptoms of SLE in young people.

BLOSSOM is looking to see if a study therapy used for adults called SAPHNELO® may also be effective in treating young people aged 5 to 17 with moderate to severe SLE.

SAPHNELO® is the brand name for the medication anifrolumab. This medication is a monoclonal antibody. It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-a and interferon-B. 3 SAPHNELO® is already approved in the United States to treat adults with SLE, but it has not yet been approved by the FDA for use in young people under 18, so its use in this trial is investigational.

How can my child join BLOSSOM?

Your child may be able to take part if they:

  • Are between 5 and 17 years old
  • Are receiving treatment for their SLE but still have symptoms

Additional criteria may apply.

You can find out more information about this trial and see if your child may be a match by visiting:.

Sources:

  1. The Lupus Foundation of America - How Many People Have Lupus in the United States? - https://www.lupus.org/resources/how-many-people-have-lupus-in-the-united-states
  2. Boston Children’s Hospital – Pediatric Lupus (Systemic lupus erythematosus) - https://www.childrenshospital.org/conditions/lupus
  3. Drugbank online – Anifrolumab - https://go.drugbank.com/drugs/DB11976


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.