Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Inclusion Criteria:

• Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for SSc with a total score of ≥9 [Van den Hoogen et al., 2013]
• At the time of enrollment, less than 36 months since the onset of the first SSc manifestation, other than Raynaud’s phenomenon
• Classified as having skin involvement proximal to elbow and/or knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
• mRSS units ≥15 at Screening

Exclusion Criteria:

• Positive for anti-centromere antibodies
• Diagnosed with sine scleroderma or limited cutaneous SSc
• Any of the following cardiovascular diseases: a.) uncontrolled, severe hypertension (≥160/100 mmHg) or persistent low blood pressure (systolic blood pressure <90 mmHg) within 6 months of Screening; b.) myocardial infarction within 6 months of Screening; c.) unstable cardiac agina within 6 months of Screening
• PAH by right heart catheterization requiring treatment with more than 1 oral PAH-approved therapy or any parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynaud’s phenomenon/digital ulcers
• Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 1 month after last dose of trial drug.