A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in 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
- 320
- 试验地点
- 124
- 主要终点
- Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
研究概览
简要总结
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
详细描述
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.
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
Participant, Site personnel (except pharmacy personnel preparing the injection), and Sponsor are 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 a clinical diagnosis of TED with or without proptosis and 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 or steroid eye drops 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 for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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. Must also not have a 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 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
干预措施: Placebo (Drug)
VRDN-003 every 4 weeks
6 subcutaneous administrations of VRDN-003
干预措施: VRDN-003 (Drug)
VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
干预措施: VRDN-003 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
时间窗: Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
次要结局
- Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer(Week 24)
- TEAE incidence rate through Week 52(Week 52)