A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

Exclusion Criteria

• •1. Decreased best-corrected visual acuity due to optic neuropathy within the last 6 months.
• •2. Corneal decompensation unresponsive to medical management in the study eye.
• •3. Decrease in proptosis of ≥ 2 mm in the study eye between Screening and Baseline.
• •4. Alanine aminotransferase or aspartate aminotransferase \> 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2 at Screening.
• •5. Use of any steroid (IV, oral, steroid eye drops) for the treatment of TED or other conditions within 3 weeks prior to Screening. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat infusion reactions.
• •6. Any treatment with rituximab, tocilizumab, or any other non-steroid immunosuppressive agent within 90 days prior to the first injection of investigational product on Day 1.
• •7. Any previous treatment with HZN-001 or TEPEZZA (teprotumumab-trbw), including previous enrollment in this trial or participation in a prior TEPEZZA trial.
• •8. Treatment with any mAb within 3 months prior to Screening.