A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis



The main purpose of this study is to understand how patients with diffuse cutaneous systemic sclerosis (dcSSc) respond to an investigational drug called HZN-825. The study drug is being tested to determine if it will work and be safe for the treatment of dcSSc. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) for treating dcSSc. 

YES.  You will be randomly assigned to receive either HZN-825 or placebo which you will take twice daily by mouth.  A placebo is a harmless inactive substance (like a sugar pill). This is a double-blind study, which means that you and the study team will not know which group you are in. 

We will use your personal health information, information from the tests and procedures done for the study, and information about how the study drug affects you to help determine if the study drug HZN-825 is safe and effective in treating dcSSc. 

There are many factors that determine if you are eligible.  Some requirements include: 

  • Diagnosed with dcSSc within the last 3 years 

  • Skin involvement near the elbow and/or knee 

You will be in the study for about 1 year and 2 months and visit the study site 12 times for tests and assessments. 

You are expected to attend all study visits and take the study drug as instructed.  Each visit will last about 1-2 hours. During some or all of the visits, you will have physical exams, lung function tests, ECG (electrocardiogram), blood and urine collection, and complete questionnaires.  You will also have to answer 3 questions in a diary every day. 


Thank you for your interest! If you wish to learn more and sign up for the study, please contact: