A Phase 2, Proof-of-Concept, Randomized, Double-Masked, Placebo-Controlled Study to Determine the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
研究概览
简要总结
LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED).
The primary and secondary objectives of this study are to evaluate the treatment effect, safety, and pharmacokinetics of LASN01 administered IV in patients with TED with no prior anti-IGF-1R treatment or in patients with TED who have previously received teprotumumab treatment.
详细描述
This clinical trial (LASN01-CL-2201) comprises a multiple-dose design in 3 parallel treatment arms for patients with TED with no prior anti-IGF-1R treatment, and a 4th treatment arm for patients with TED who have previously received teprotumumab treatment.
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)
盲法说明
Double masked treatment arms for patients without prior anti-IGF-1R treatment, and open-label treatment arm for patients with prior teprotumumab treatment
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
- •Male or female patients ≥18 years of age at the time of Screening
- •Clinical diagnosis of Graves' disease associated with active TED
- •Moderate-to-severe active TED
- •Female patients must be nonpregnant, nonlactating, surgically sterile for ≥6 months, or agree to use a highly effective method of contraception. Males must be surgically sterile or agree to use a highly effective method of contraception.
- •No previous:
- •Medical treatment for TED, with the exception of:
- •Local supportive measures;
- •Mycophenolate, and oral or injectable steroids;
- •Immunomodulating therapies
- •For the open-label treatment arm only: Previous treatment with teprotumumab is required.
- •Orbital surgery
- •Orbital radiation
- •Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms
- •With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease
排除标准
- •Patients with 2 mm proptosis decrease between Screening and Day 1, or a 1-point decrease on the CAS 7-point scale between Screening and Day 1
- •Patients with a known decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 3 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening; or any known optic neuropathy or compression or any neurologic or neuro-ophthalmologic condition that may result in visual field loss.
- •Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU)
- •Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Day 1 (topical steroids for conditions other than TED are allowed)
- •Active autoimmune disorder(s) requiring or likely to require treatment (other than Grave's disease and TED) that would interfere with study assessments, as determined by the PI or designee
- •Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time, with exception to the open-label post-teprotumumab treatment arm where prior use of teprotumumab is required
- •Use of selenium within 3 weeks before Day 1 or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses)
- •Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection
研究组 & 干预措施
Randomized low-dose LASN01 (anti-IGF-1R-naïve TED)
干预措施: LASN01 (Drug)
Randomized high-dose LASN01 (anti-IGF-1R-naïve TED)
干预措施: LASN01 (Drug)
Randomized placebo (anti-IGF-1R-naïve TED)
干预措施: Placebo (Drug)
Open-label high dose LASN01 (post-teprotumumab, US only)
干预措施: LASN01 (Drug)
结局指标
主要结局
For Open-label Treatment Arm: Number of Participants With Adverse Events Receiving LASN01
时间窗: Day 1-Day 393
Percentage of Participants Showing a Response in Proptosis Measured Using Hertel Exophthalmometer (≥2 mm Decrease From Baseline) in the Study Eye and Separately in Either Eye Without Increased Proptosis (≥2 mm Increase) in the Other Eye
时间窗: Day 1-Day 253
For Randomized Treatment Arms: Number of Participants With Adverse Events Receiving LASN01 Compared to Placebo
时间窗: Day 1-Day 393
Pooled analysis of 300 and 600 mg Q4W as compared with placebo.
次要结局
- Percentage of Participants Showing a Response in Clinical Activity Score (CAS) in the Study Eye Compared to Baseline as Assessed by CAS Evaluation(Day 1-Day 253)