Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

Официальное название

A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

Обзор

The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).

Вмешательства

• Препарат linsitinib
  150 mg linsitinib is taken twice daily by mouth for 24 weeks
• Препарат Placebo
  0 mg placebo taken twice daily by mouth for 24 weeks

Первичные конечные точки

• Measure percentage of participants who are Proptosis Responders at Week 24 [Срок оценки: 24 weeks]

Вторичные конечные точки (4)

• Mean change from Baseline in Proptosis to Week 24 [Срок оценки: 24 Weeks]
• Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24 [Срок оценки: 24 Weeks]
• Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score. [Срок оценки: 24 Weeks]
• Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye. [Срок оценки: 24 Weeks]

Критерии участия

Критерии включения

• Participants must be ≥ 18 years of age at Screening
• Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
• Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
• Participants 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 of the central laboratory) at Screening.
• Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.

Критерии исключения

• Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.
• Corneal decompensation unresponsive to medical management.
• Previous orbital irradiation or orbital surgery in either eye.
• Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening.
• Prior IGF-1R inhibitor therapy for any condition.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Advancing Research International — Las Vegas

Идентификаторы

NCT: NCT07753603 · SLG-TED-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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