2023-508161-32-00已完成2 期
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
Lassen Therapeutics 1 Inc.5 个研究点 分布在 2 个国家目标入组 11 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and efficacy of 2 dose levels of LASN01 administered IV in patients with thyroid eye disease (TED).
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow Up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
- •Less than 15 months from day 1 of TED symptoms
- •No previous: ● Medical treatment for TED, with the exception of: local supportive measures; mycophenolate, and oral or injectable steroids; immunomodulating therapies ● surgical treatment in the study eye ● any history of orbital radiation● any history of orbital surgery in the study eye
- •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.
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 during the 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 ETDRS chart (or equivalent), 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 planned orbital surgery for TED during the study period (ie, treatment and FU)
- •Use of oral and/or IV corticosteroid for conditions other than TED <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
- •Previous use of an anti-IGF-1R targeted treatment at any time
- •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
结局指标
主要结局
Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer
Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer
Safety: To assess the safety and tolerability of LASN01 compared with placebo in patients with TED as assessed by changes in adverse events, concomitant medications, clinical laboratory evaluations, vital signs, ECGs, and physical examinations
Safety: To assess the safety and tolerability of LASN01 compared with placebo in patients with TED as assessed by changes in adverse events, concomitant medications, clinical laboratory evaluations, vital signs, ECGs, and physical examinations
次要结局
- Changes in TED-related clinical parameters (proptosis, CAS, lid retraction, lid aperture, lagophthalmos, Von Graefe’s sign, and diplopia) in the study eye compared to baseline
- PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (Tmax)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
- PK parameter assessed by serum LASN01 concentration at specified timepoints for half-life (t1/2)
研究者
Maria Fardis
Scientific
Lassen Therapeutics 1 Inc.
研究点 (5)
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