A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Inclusion criteria

• ✓. Written informed consent.
• ✓. Male or female between the ages of 18 and 80 years, inclusive, at Screening.
• ✓. Meets the 2013 American College of Rheumatology/European League Against Rheumatism classification criteria for systemic sclerosis (SSc) with a total score of ≥9.
• ✓. Classified as having skin involvement proximal to elbow, knee, face and neck.
• ✓. At the time of enrollment, no more than 60 months must have elapsed since the onset of the first dcSSc manifestations, other than Raynaud's phenomenon.
• ✓. Skin thickening from dcSSc in the forearm suitable for repeat biopsy.
• ✓. Modified Rodman Skin Score (mRSS) units ≥10 and ≤45 at Screening.
• ✓. Participant will be allowed to take CellCept® (mycophenolate mofetil) up to 3 g/day or Myfortic® (mycophenolic acid) up to 2.14 g/day and low-dose prednisone (≤10 mg/day or equivalent dosing of glucocorticoids). Participants taking CellCept or Myfortic have been doing so for ≥20 weeks and the dose must have been stable for ≥16 weeks prior to the Day 1 Visit. Prednisone must have been at a stable dose for ≥4 weeks prior to the Day 1 Visit.

Exclusion criteria