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

Brief description of study

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.

Detailed description of study

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 would be in the study for about 1 year and 2 months and visit the study site 12 times for tests

and assessments.

You would be randomly assigned to receive either HZN-825 or placebo which you would 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Medical Research,scleroderma,SSc,diffuse cutaneous systemic sclerosis,dcSSc,systemic sclerosis
Age: Between 18 Years - 90 Years
Gender: All

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

Updated on 09 Mar 2024. Study ID: 849800

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