Welcome to the BRAVOS Study
The main goal of the BRAVOS study is to determine the safety of an investigational study drug, brentuximab vedotin (ADCETRIS®), in dcSSc. Researchers will also assess whether ADCETRIS® has any effect on symptoms associated with dcSSc, and will examine the effect of the ADCETRIS® on the immune system by looking at blood and skin samples.
About the Investigational Study Drug
Brentuximab vedotin (ADCETRIS®) is approved by the FDA for the treatment of Hodgkin’s and other lymphomas. Researchers think brentuximab vedotin (ADCETRIS®) might also work in dcSSc by attaching to the immune cells that cause dcSSc. Since it has never been tested in patients with dcSSC, brentuximab vedotin (ADCETRIS®) it is considered an experimental drug for this disease.
Brentuximab vedotin (ADCETRIS®) is a drug that attaches to the CD30 protein on cells and releases a toxin into the cell, causing the cell to die. CD30 is a protein found at low levels on the surface of normal healthy white blood cells. However, the CD30 protein is increased on certain types of cancer cells, and also may be increased on the overactive immune cells involved with inflammation and fibrosis in dcSSc.
Participating in the BRAVOS Study
This BRAVOS study is a placebo-controlled trial, which means that some participants will get brentuximab vedotin (ADCETRIS®) and some will get an inactive substance called a placebo. This study is double-blinded, which means that during the study neither you nor your study doctor will know whether you are receiving brentuximab vedotin (ADCETRIS®) or placebo. Three quarters of participants will receive one of three dosages of brentuximab vedotin (ADCETRIS®) and one quarter will receive placebo. You cannot choose your group. A computer randomly picks who gets brentuximab vedotin (ADCETRIS®) and who gets placebo.
A total of eight doses of brentuximab vedotin (ADCETRIS®) or placebo will be given by intravenous infusion once every 3 weeks over a 21 week period. Then there will be 4 follow-up visits over the next 6 months. Total study time is 1 year.
The study visits are summarized below:
|Treatment Period||5 months (21 weeks)||8 clinic visits and intravenous infusions given every 3 weeks|
|Follow-up Period||Approximately 6 months||Four clinic visits over 6 months|