ITN’s BRAVOS (Evaluation of Brentuximab Vedotin for Diffuse Cutaneous System Sclerosis) has opened for recruitment. The goal of this clinical trial is to determine the safety of an investigational study drug, brentuximab vedotin (ADCETRIS®), in diffuse cutaneous systemic sclerosis (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.
Diffuse cutaneous systemic sclerosis (dcSSc), also known as progressive scleroderma, is an autoimmune disease, in which the body’s immune system attacks the skin, causing tightness and thickening, and can also affect the internal organs, including the joints, lungs, heart, intestinal tract, and kidneys.
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.
BRAVOS is a placebo-controlled trial, double-blinded study. Three quarters of participants will receive one of three dosages of brentuximab vedotin (ADCETRIS®) and one quarter will receive placebo.
The BRAVOS Study will take place at 10 site locations across the U.S.
To learn more about the BRAVOS Study, please visit bravos-study.org.