2025-522403-17-00招募中3 期
A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 73
- 主要终点
- 1. Percentage of participants achieving endpoint reduction from baseline at Week 24.
研究概览
简要总结
To evaluate the efficacy of lebrikizumab compared to placebo up to Week 24 in participants with NE who are not adequately controlled with TCS or when this treatment is not medically advisable.
研究设计
- 分配方式
- Randomized
- 主要目的
- Blinded Extension period
- 盲法
- Double (Analyst, Subject, Investigator, Carer, Monitor)
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
- •Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines.
- •Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
- •Presence of NE signs and/or symptoms for at least 6 months prior to Screening.
排除标准
- •Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI ≥16).
- •Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).
- •Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.
- •History of anaphylaxis as defined by the Sampson criteria.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •History of sensitivity and/or allergy to any of the ingredients of the trial medication.
- •Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
研究组 & 干预措施
Ebglyss 250 mg solution for injection in pre-filled syringe
Test
干预措施: Ebglyss 250 mg solution for injection in pre-filled syringe (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
1. Percentage of participants achieving endpoint reduction from baseline at Week 24.
1. Percentage of participants achieving endpoint reduction from baseline at Week 24.
次要结局
- 1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24
- 2. Absolute change from baseline in DLQI to Week 24.
研究者
Regulatory Strategy
Scientific
Almirall S.A.
研究点 (73)
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