NCT04250350已完成3 期
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 140
- 主要终点
- Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
研究概览
简要总结
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
- •Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
- •Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- •Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
- •≥10% body surface area (BSA) of AD involvement at the baseline visit.
- •History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
排除标准
- •Participation in a prior lebrikizumab clinical study.
- •Treatment with the following prior to the baseline visit:
- •An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- •Dupilumab within 8 weeks.
- •B-cell-depleting biologics, including to rituximab, within 6 months.
- •Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- •Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- •Evidence of active acute or chronic hepatitis
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
结局指标
主要结局
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
时间窗: Week 52
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
次要结局
- Change From Baseline in Body Surface Area (BSA)(Baseline, Week 52)
- Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety(Baseline, Week 52)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline, Week 52)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)(Baseline, Week 52)
- Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression(Baseline, Week 52)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)(Week 52)
- Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab(Predose: Week 52)
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline(Week 52)
- Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)(Week 52)
- Percentage Change From Baseline in EASI Score(Baseline, Week 52)
- Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)(Week 52)
研究者
研究点 (140)
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