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

Exclusion Criteria

• •1. Diagnosed with limited cutaneous SSc or sine scleroderma.
• •2. Diagnosed with other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma associated myopathy and Sjogren's syndrome.
• •3. Scleroderma renal crisis diagnosed within 6 months of the Screening Visit, characterized by abrupt onset of hypertension and acute kidney injury.
• •4. Forced vital capacity (FVC) \<50% predicted, diffusing capacity of the lungs for carbon monoxide (DLCO) \<40% predicted or pulmonary arterial hypertension (PAH) by right heart catheterization requiring treatment with more than one oral PAH approved therapy or parenteral therapy (intermittent use of phosphodiesterase-5 inhibitors are allowed for erectile dysfunction and/or Raynaud's phenomenon/digital ulcers).
• •5. Corticosteroid use for conditions other than dcSSc within 4 weeks prior to Screening (topical steroids for dermatological conditions and inhaled steroids are allowed).
• •6. Previous treatment with rituximab (Rituxan® or MabThera®) within 12 months prior to the first infusion.
• •7. Use of a non-steroidal immunosuppressive agent, cytotoxic or anti-fibrotic drug within 4 weeks of Screening, including cyclophosphamide, azathioprine (Imuran®), methotrexate or other immunosuppressive or cytotoxic medication. Exceptions are mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic), which are permitted according to inclusion criterion 8, and anti-malarials (e.g., hydroxychloroquine \[Plaquenil®\]).
• •8. Use of biologics or small molecules approved for rheumatoid arthritis, psoriatic arthritis and other rheumatic diseases within 4 weeks prior to Screening.
• •9. Use of an investigational agent for any condition within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipated use during the course of the trial.
• •10. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
• •11. Pregnant or lactating women.
• •12. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the participant.
• •13. Biopsy-proven or clinically suspected inflammatory bowel disease (e.g., diarrhea with or without blood or rectal bleeding associated with abdominal pain or cramping/colic, urgency, tenesmus or incontinence for more than 4 weeks without a confirmed alternative diagnosis OR endoscopic or radiologic evidence of enteritis/colitis without a confirmed alternative diagnosis).
• •14. Known hypersensitivity to any of the components of TEPEZZA or prior hypersensitivity reactions to mAbs.
• •15. Previous enrollment in this study or participation in a prior teprotumumab-trbw clinical trial.
• •16. Human immunodeficiency virus, untreated or positive viral load for hepatitis C or hepatitis B infections.
• •17. Previous organ transplant (including allogeneic and autologous marrow transplant).
• •18. Alanine aminotransferase or aspartate aminotransferase \>2.5 times the upper limit of normal or estimated glomerular filtration rate of \<30 mL/min/1.73m\^2 at Screening.
• •19. Platelets \<100×10\^3/µL.
• •20. Hemoglobin \<8 g/dL.
• •21. Any other condition that, in the opinion of the Investigator, would preclude inclusion in the study.