A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Inclusion Criteria:

• Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditisassociated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale)for the most severely affected eye (primary study eye) at Screening and Baseline

• Confirmed active TED (not sight-threatening but has an appreciable impact on dailylife, with onset (as determined by patient records) within 12 months prior to theBaseline visit and usually associated with one or more of the following: lidretraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mmabove normal for race and gender, and/or inconstant or constant diplopia.

• Subjects must be euthyroid with the participant's baseline disease under control orhave mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and freetriiodothyronine levels [FT3] < 50% above or below the normal limits) at Screening.

• Does not require immediate ophthalmic surgery, radiotherapy to orbits or otherophthalmological intervention at the time of Screening and is not planning for anysuch treatment during the course of the study.

Exclusion Criteria:

• Decreased best corrected visual acuity due to optic neuropathy as defined by adecrease in vision of 2 lines on the Snellen chart, new visual field defect, orcolor defect secondary to optic nerve involvement within the last 6 months.

• Corneal decompensation unresponsive to medical management.

• Previous orbital irradiation or orbital surgery.

• Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalentto >= 1g of methylprednisolone or equivalent for the treatment of TED within 3months of Screening.

• Prior IGF-1R inhibitor therapy for any condition.