A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 16
- 主要终点
- Treatment Emergent Adverse Event (TEAE) incidence rate
研究概览
简要总结
This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)
详细描述
This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.
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
- None
盲法说明
This is an open label study with no masking
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 a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
- •Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- •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
- •Must not have received prior treatment with another anti-IGF-1R therapy
- •Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
- •Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose
- •Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose
- •Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- •Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
- •Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
- •Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor
- •Must not have a history of inflammatory bowel disease
- •Female TED participants must not be pregnant or breastfeeding
研究组 & 干预措施
VRDN-003 every 4 weeks using autoinjector
6 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 5 doses of 300mg]
干预措施: VRDN-003 (Drug)
VRDN-003 every 4 weeks using autoinjector
6 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 5 doses of 300mg]
干预措施: Autoinjector (Device)
VRDN-003 every 8 weeks using autoinjector
3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg]
干预措施: Autoinjector (Device)
VRDN-003 every 8 weeks using autoinjector
3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg]
干预措施: VRDN-003 (Drug)
VRDN-003 every 8 weeks using vial and syringe
3 subcutaneous administrations of VRDN-003 [1 loading dose of 600mg and 2 doses of 300mg]
干预措施: VRDN-003 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Event (TEAE) incidence rate
时间窗: Through Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate
次要结局
- Pharmacokinetic outcome measures(Through Week 24)