2024-519811-32-00招募中4 期
An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis
Region Oestergoetland4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
研究概览
简要总结
The primary objective of this trial is to confirm the effectiveness of lebrikizumab in improving eczema in patients with moderate-to-severe AD.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The participant has given their written consent to participate in the trial.
- •Adults (aged 18-64) and adolescents (aged ≥12 to <18 years at the time of ICF/informed assent form (IAF) signature and weighing ≥40 kg) who are candidates for systemic AD therapy.
- •Diagnosis of AD and a history of inadequate topical treatment response as assessed by the clinician.
- •Adolescent participants (aged ≥12 to <18 years) must have their written informed consent signed by the parent/legal guardian. Adolescent participants from 15 years also need to give their own written consent to participate in the trial.
排除标准
- •Hypersensitivity to the active substances or to any of the excipients of lebrikizumab
- •Patients with pre-existing helminth infections
- •Concomitant use of live and live attenuated vaccines
- •Pregnant and/or breastfeeding women.
- •Patients unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study
- •Patients unable to understand the study’s information and conduct in Swedish or English translations of the material
结局指标
主要结局
The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
The percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 24, the final visit of the study.
次要结局
- Alternative clinically evaluated endpoint measures (IGA ≤1 and≥2 point improvement; DLQI≥4 point improvement; NRS ≥4 point improvement);
- Registry-based (EG: SwedAD) PROMS (POEM, MADRS-S, RECAP)
- Vitamin D status in blood and skin biopsy (adults only)
- Skin physiological outcome measures in the form of EIS in all patients and evaporimetry, Epsilon and TiVi in a subgroup
- NMF and Skin lipid sampling (tape stripping in all and biopsy for ToF-SIMS in an adult subgroup
研究者
Sponsor's Representative
Scientific
Region Oestergoetland
研究点 (4)
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