A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate theSafety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED) - VGN-TED-301

Sling Therapeutics Inc.0 个研究点目标入组 18 人开始时间: 2024年6月7日最近更新: 2024年8月21日

适应症

试验速览

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•Clinical diagnosis of Graves’ Disease and/or autoimmune Hashimoto’s thyroiditis associated 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., TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 12 months prior to the Screening visit and usually associated with one or more of the following: lid retraction = 2 mm, moderate or severe soft tissue involvement, exophthalmos = 3 mm above normal for race and gender, and/or inconstant or constant diplopia., Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] <50% above or below the normal limits) at Screening.

•Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color 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 equivalent to = 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.

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