An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 83
- 主要终点
- Proptosis Responder Rate in the most proptotic eye
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 thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
- •Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
- •Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
- •Not require immediate surgical 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 urine pregnancy test at screening
- •Be willing and able to comply with all the requirements of the protocol for the entire duration of the study
排除标准
- •Participants must not:
- •Have received prior treatment with another anti-IGF-1R agent
- •Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
- •Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
- •Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- •Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
- •Have abnormal hearing test before first dose. Have a history of ear conditions considered significant by study doctor
研究组 & 干预措施
Veligrotug/Veligrotug
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 milligrams (mg)/kilogram (kg) every 3 weeks (Q3W) for 12 weeks.
干预措施: Veligrotug (Drug)
Placebo/Veligrotug
Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 will receive veligrotug 10 mg/kg Q3W for 12 weeks.
干预措施: Veligrotug (Drug)
结局指标
主要结局
Proptosis Responder Rate in the most proptotic eye
时间窗: Week 15
Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the other eye\]) as measured by exophthalmometer
Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer
时间窗: Baseline to Week 15
Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were not imputed.
次要结局
- Proptosis Responder Rate in the most proptotic eye(Week 15)
- Change from Baseline in proptosis in the most proptotic eye(Week 15)
- Change from baseline in proptosis in the most proptotic eye(Week 15)
- Diplopia Resolution Rate(Week 15)
- Clinical Activity Responder Rate in the most proptotic eye(Week 15)
- Diplopia Responder Rate(Week 15)
- Overall Responder Rate in the most proptotic eye(Week 15)
- Diplopia Responder Rate(Week 15)
- Diplopia Resolution Rate(Week 15)
- Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer(Baseline, Week 15)
- PRR in the Most Proptotic Eye as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)(Baseline to Week 15)
- Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT(Baseline, Week 15)
- Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer(Week 15)
- ORR Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer(Baseline to Week 15)