Behçet's Syndrome clinical trials at UC Health
1 in progress, 0 open to eligible people
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
Sorry, in progress, not accepting new patients
Behçet's disease, is a rare disorder that causes inflammation in blood vessels throughout the body. The signs and symptoms of Behçet's disease may include mouth sores, eye inflammation, skin rashes and lesions, and genital sores that vary from person to person and may come and go on their own. The exact cause of Behçet's is unknown, but it may be an autoimmune disorder, which means the body's immune system mistakenly attacks some of its own healthy cells. This study will evaluate if apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment of oral ulcers in subjects with active Behçet's disease. Other manifestations of the disease will also be assessed, such as, pain and tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also will test how well the body tolerates apremilast. In addition, the second purpose of the study is to assess the safety of apremilast in patients with Behçet's disease. This study is a randomized, placebo-controlled, parallel design. About 204 subjects will participate. The placebo-controlled period will be 12 weeks long and patients will receive apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive apremilast for 52-week. All participants will have their final study visit 4 weeks after stopping apremilast treatment.
at UC Davis