A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 50
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
研究概览
简要总结
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
详细描述
A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (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
- Double (Participant, Investigator)
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 clinical activity score (CAS) (0 - 7) and in the opinion of the investigator may benefit from treatment
- •Must agree to use highly effective contraception method as specified in the protocol
- •Female TED participants must have a negative serum pregnancy test at screening
- •Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
排除标准
- •Must not have received prior treatment with another anti-IGF-1R therapy
- •Must not have used systemic corticosteroids, or selenium within 2 weeks prior to Day 1
- •Must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to Day 1
- •Must not have received any other therapy for TED within 8 weeks prior to Day 1
- •Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
- •Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
- •Must not have had previous orbital irradiation or decompression surgery involving excision of fat for TED in the study eye's orbit
- •Must not have inflammatory bowel disease
- •Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor.
- •Female TED participants must not be pregnant or lactating.
研究组 & 干预措施
Veligrotug 3 mg/kg
Participants will receive 5 IV infusions of veligrotug 3 mg/kg at 3-week intervals for 12 weeks.
干预措施: Veligrotug (Drug)
Veligrotug 10 mg/kg
Participants will receive 5 intravenous (IV) infusions of veligrotug 10 milligrams (mg)/kilogram (kg) at 3-week intervals for 12 weeks.
干预措施: Veligrotug (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
时间窗: Baseline through Week 15
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Treatment Emergent Adverse Event (TEAE) incidence rate
时间窗: Week 15
次要结局
- Change from baseline in proptosis in the study eye as measured by exophthalmometer(Week 15)
- Treatment Emergent Adverse Event (TEAE) incidence rate(Week 52)
- Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer(Baseline, Week 15)
- Number of Participants With TEAEs Through Week 52(Baseline through Week 52)