Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED) (TED)

Key Inclusion Criteria: Male or female, ≥18 and ≤70 years of age. Proptosis defined in the study eye as ≥3 mm above normal. Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye Onset of active TED symptoms within 15 months prior to the baseline Must agree to use highly effective contraception as specified in the protocol Key Exclusion Criteria: Pathology related to inflammatory bowel disease or irritable bowel syndrome. Clinically significant pathology related to hearing or history of hearing impairment Optic neuropathy Corneal decompensation unresponsive to medical management. Previous orbital irradiation (for any cause) or any previous surgical treatment for TED. Subjects with diabetes or hemoglobin A1c >6.0% at screening Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to >3 g of methylprednisolone for the treatment of TED within the last year. Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed 1 g total dose in the 8 weeks prior to Screening. Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor. Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab and tocilizumab) Any other immunosuppressive agent within 1 month of screening.