A Phase 4, Single-Arm, Open-Label Trial to Evaluate the Safety and Efficacy of Veligrotug in Participants With Thyroid Eye Disease (TED) Who Previously Responded to Teprotumumab
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Safety and tolerability of veligrotrug (LUMVOA™)
研究概览
简要总结
This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.
详细描述
This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence.
The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have a diagnosis of TED with associated signs and symptoms.
- •Must have completed an initial full course of treatment (8 infusions over approximately 21 weeks) with teprotumumab ≥9 months prior to screening.
- •Must have a documented clinical response to teprotumumab.
- •Must have evidence of recurrence following the completion of prior teprotumumab treatment course, as measured by exophthalmometer in the study eye.
- •Must have a Clinical Activity Score (CAS) ≥3 in the study eye.
- •Must not require immediate orbital surgery in the study eye during the anticipated duration of the trial.
- •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 sight-threatening TED (eg, dysthyroid optic neuropathy).
- •Must not have received IGF-1R inhibitor therapy within 9 months prior to screening or received any IGF-1R inhibitor other than teprotumumab at any time.
- •Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to the first dose.
- •Must not have received other immunosuppressive drugs for any condition, including TED, within 12 weeks prior to the first dose or any other therapy for TED (except for artificial tears) within 8 weeks prior to the first dose.
- •Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose.
- •Must not have 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 trial results.
- •Must not have abnormal hearing test before first dose or any history of hearing impairment. Must not also have any history of ear conditions considered significant by the study doctor.
- •Must not have a history of inflammatory bowel disease.
- •Female participants must not be pregnant or breastfeeding.
研究组 & 干预措施
5 IV infusions of 10 mg/kg of veligrotug
Participants will receive veligrotug10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.
干预措施: veligrotrug (LUMVOA™) (Drug)
结局指标
主要结局
Safety and tolerability of veligrotrug (LUMVOA™)
时间窗: Through Week 15
Treatment Emergent Adverse Event (TEAE) incidence rate
次要结局
未报告次要终点