NCT06557850进行中（未招募）1 期
Interventional, Open-label, Single-group, Long-term Follow-up Trial of Lu AG22515 in Patients With Moderate-to-severe Thyroid Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer
研究概览
简要总结
This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease.
In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has Graves' disease associated Thyroid Eye Disease (TED) symptoms characterized by:
- •ophthalmologic symptom onset <12 months prior to the Baseline Visit
- •proptosis ≥3 millimeter (mm) above normal for race and sex measured using the Hertel exophthalmometer (at the Screening Visit and the Baseline Visit) in the most severe eye
- •Clinical Activity Score (CAS) ≥3 in the most severe eye at the Screening Visit.
- •The participants must be euthyroid or have mild hypo- or hyperthyroidism (defined as free thyroxin [FT4] and/or free triiodothyronine [FT3] levels not exceeding the normal limits +/-50%) at the Screening Visit.
排除标准
- •The participant has a decreased best-corrected visual acuity due to optic neuropathy, defined as a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or colour defect secondary to optic nerve involvement, within 6 months prior to the Screening Visit.
- •The participant has corneal decompensation unresponsive to medical management.
- •The participant has a decrease in proptosis of ≥2 mm between the Screening Visit and the Baseline Visit.
- •The participant has a decrease in CAS of ≥2 points between the Screening Visit and the Baseline Visit.
- •The participant has had previous orbital irradiation or surgery for TED.
- •The participant requires immediate surgical ophthalmological intervention or has other eye conditions impacting the assessments.
- •The participant has contraindications for an magnetic resonance imaging (MRI) scan.
- •The participant has an active infection at Baseline or recent serious infection (for example, requiring hospitalization) within 8 weeks prior to the Baseline Visit.
- •The participant takes any of the following disallowed or restricted concomitant medications (the list is not comprehensive):
- •Disallowed: any investigational products within 30 days or 5 half-lives, whichever is longer, prior to the Screening Visit, systemic corticosteroids within 6 weeks prior to the Screening Visit (topical steroids for dermatological conditions, inhaled or intranasal steroids are allowed), systemic immunosuppressive/immunomodulating drugs (for example, rituximab, tocilizumab, methotrexate, cyclosporine, azathioprine, mycophenolate-sodium/mofetil, Janus kinase inhibitors) within 5 half-lives prior to the Screening Visit, live attenuated vaccines within 30 days prior to the Baseline Visit, biotin within 1 day prior to the Screening Visit.
- •Allowed with restriction: stable dose for >3 weeks prior to the Screening Visit of selenium. Inactivated/killed/RNA-based vaccinations are allowed provided they are not administered within 5 days before/after any investigational medicinal product (IMP) trial visits.
研究组 & 干预措施
Lu AG22515
Experimental
Participants will receive intravenous (IV) administration of Lu AG22515 per a prespecified dosing schedule.
干预措施: Lu AG22515 (Drug)
结局指标
主要结局
Change in Proptosis from Baseline to Week 24 in the Trial Eye Using the Hertel Exophthalmometer
时间窗: Baseline, Week 24
次要结局
- Tmax: Time to Maximum Observed Cmax of Lu AG22515(Predose up to Week 52)
- Cmax: Maximum Observed Serum Concentration of Lu AG22515(Predose up to Week 52)
- Ctrough: Minimum Observed Serum Concentration of Lu AG22515(Predose up to Week 52)
- Volume of Distribution of Lu AG22515(Predose up to Week 52)
- AUC0-infinity: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Lu AG22515(Predose up to Week 52)
- t½: Apparent Elimination Half-life of Lu AG22515(Predose up to Week 52)
- CL: Apparent Total Serum Clearance of Lu AG22515(Predose up to Week 52)
- Number of Participants with Anti-drug Antibodies(Up to Week 52)
研究者
研究点 (12)
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