Summary:
If you have diffuse cutaneous systemic sclerosis (dcSSc), you may be able to take part in a clinical research study.
The purpose of the BEACON Study is to evaluate the effectiveness, safety and tolerability of an investigational medicine compared to a placebo in individuals ages 18 to 75 with diffuse cutaneous systemic sclerosis (dcSSc). The BEACON Study is evaluating if the investigational medicine (HZN-825) may slow disease progression in participants with dcSSc. The investigational medicine is a tablet taken orally twice daily.
All participants who qualify will receive the investigational medicine or a placebo, as well as study-related exams and study-related laboratory tests at no cost. Compensation for time and travel may also be available.
Eligible participants must:
- Be between 18 and 75 years of age
- Have a current diagnosis of dcSSc
- Not be diagnosed with sine scleroderma, limited cutaneous systemic sclerosis, scleroderma renal crisis or other autoimmune connective tissue diseases except for fibromyalgia, scleroderma-associated myopathy and secondary Sjögren’s syndrome
- Have skin involvement near the elbow or knee
- Have had less than three years pass since first experiencing systemic sclerosis symptoms, other than Raynaud’s phenomenon
Other protocol-defined inclusion and exclusion criteria may apply.