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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 53
- 主要终点
- Proptosis Responder Rate in the study eye
研究概览
简要总结
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, Investigator, Outcomes Assessor and Sponsor will be masked.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Randomized controlled period: ZL-1109 every 4 weeks
Participants will receive ZL-1109 per protocol defined dosing regimen.
干预措施: ZL-1109 (VRDN-003) (Drug)
Randomized controlled period: Placebo every 4 weeks
Participants will receive placebo per protocol defined dosing regimen.
干预措施: Placebo (Drug)
Randomized controlled period: ZL-1109 every 8 weeks
Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.
干预措施: ZL-1109 (VRDN-003) (Drug)
Randomized controlled period: ZL-1109 every 8 weeks
Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.
干预措施: Placebo (Drug)
OLE treatment period: ZL-1109 every 4 weeks
Participants who not responded would receive ZL-1109 per protocol defined dosing regimen.
干预措施: ZL-1109 (VRDN-003) (Drug)
结局指标
主要结局
Proptosis Responder Rate in the study eye
时间窗: At Week 24
Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
次要结局
- Change from baseline in proptosis in the study eye(At Week 24)
- Overall Responder Rate in the study eye(At Week 24)
- Change from baseline in Clinical Activity Score (CAS) in the study eye(At Week 24)
- Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye(At Week 24)
- Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0(At Week 24)
- Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0(At Week 24)
- Clinical Activity Responder Rate in the study eye(At Week 24)