A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease

Официальное название

A Multicenter, Double-blinded, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ZL-1109 in Chinese Participants With Thyroid Eye Disease (TED)

Обзор

A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)

Подробное описание

This is a multicenter, Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZL-1109 in participants with active TED. The study will comprise a screening period of up to 28 days, a double-blinded randomized placebo-controlled period of 24 weeks and an extension period. For responders and non-responders who do not want to receive open-label treatment, the study period is 52 weeks from the first dose. For non-responders who consent to and are considered eligible to receive open-label treatment, the study period is 70 weeks from the first dose.

Вмешательства

• Препарат ZL-1109 (VRDN-003)
  ZL-1109 subcutaneous injection
• Препарат Placebo
  Matching placebo subcutaneous injection

Первичные конечные точки

• Proptosis Responder Rate in the study eye [Срок оценки: At Week 24]

Вторичные конечные точки (7)

• Change from baseline in proptosis in the study eye [Срок оценки: At Week 24]
• Overall Responder Rate in the study eye [Срок оценки: At Week 24]
• Change from baseline in Clinical Activity Score (CAS) in the study eye [Срок оценки: At Week 24]
• Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye [Срок оценки: At Week 24]
• Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0 [Срок оценки: At Week 24]
• Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0 [Срок оценки: At Week 24]
• Clinical Activity Responder Rate in the study eye [Срок оценки: At Week 24]

Критерии участия

Критерии включения

• Have moderate to severe TED
• Must meet the clinical diagnosis criteria of active TED
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test at screening

Критерии исключения

• Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb.
• Have received systemic corticosteroids or steroid eye drops for any condition, or other immunosuppressive drugs for any condition, including TED, or radioactive iodine (RAI) treatment within a certain period prior to first dose.
• Have corneal decompensation in the study eye unresponsive to medical management.
• Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 27 центров

• Site01006 — Пекин
• Site01009 — Пекин
• Site01010 — Пекин
• Site01029 — Bengbu
• Site01020 — Чанша
• Site01022 — Чэнду
• Site01031 — Чунцин
• Site01011 — Dalian
• … и ещё 19 центров

Идентификаторы

NCT: NCT07211776 · ZL-1109-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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