2024-519417-57-00
招募中
3 期
A randomized, double-masked, controlled, safety and tolerability study of VRDN-003 in participants with thyroid eye disease (TED)
Viridian Therapeutics Inc.30 个研究点 分布在 4 个国家目标入组 111 人开始时间: 2025年6月5日最近更新:
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Viridian Therapeutics Inc.
- 入组人数
- 111
- 试验地点
- 30
- 主要终点
- The primary study endpoint will assess the rate at which safety events occur after starting treatment with VRDN-003 (Treatment Emergent Adverse Event) through Week 24.
概览
简要总结
To evaluate if VRDN-003 is safe and tolerable (meaning if the body reacts acceptably to VRDN-003) when administered as a series of subcutaneous/SC (injection into layer of fat between skin and muscle) injections given every 4 weeks or every 8 weeks in participants with TED of any duration.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult males or females, ≥18 to ≤75 years of age
- •Have a clinical diagnosis of TED of any duration and in the opinion of the Investigator may benefit from VRDN-003
- •Must agree to use highly effective contraception as specified in the protocol
- •Female participants must have a negative pregnancy test at first study visit
排除标准
- •Received prior treatment with another anti-IGF-1R therapy
- •Received corticosteroids (drugs that reduce inflammation in the body) or steroid eye drops for any condition, including TED, within 2 weeks prior to first dose.
- •Received other immunosuppressive drugs (drugs that dampen the body’s immune response) or any other therapy for TED within 12 weeks prior to first dose or another investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose.
- •Have had previous orbital irradiation or decompression surgery for TED or a preexisting eye condition which in the study doctor’s opinion, would interfere with interpretation of study results
- •Have abnormal hearing test before first dose. History of ear conditions considered significant by study doctor
- •Have inflammatory bowel disease (conditions that involve inflammation of the gastrointestinal [GI] tract)
- •Female participants who are pregnant or breastfeeding
结局指标
主要结局
The primary study endpoint will assess the rate at which safety events occur after starting treatment with VRDN-003 (Treatment Emergent Adverse Event) through Week 24.
The primary study endpoint will assess the rate at which safety events occur after starting treatment with VRDN-003 (Treatment Emergent Adverse Event) through Week 24.
次要结局
- Changes in eye bulging at Week 24 versus measurements before the first dose.
- The rate at which safety events occur after starting treatment with VRDN-003 through Week 52.
研究者
Chief Medical Officer
Scientific
Viridian Therapeutics Inc.
研究点 (30)
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