A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 125
- 主要终点
- Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult and adolescents (≥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.
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 With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.
时间窗: Baseline to Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16
时间窗: Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
次要结局
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2(Baseline to Week 2)
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percent Change in EASI Score From Baseline at Week 16(Baseline, Week 16)
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
- Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16(Baseline to Week 16)
- Change From Baseline to Week 16 in Percent Body Surface Area (BSA)(Baseline, Week 16)
- Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1(Baseline to Week 1)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16(Baseline to Week 16)
- Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving EASI-90 at Week 4(Baseline to Week 4)
- Percent Change in Sleep-loss Score From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Sleep-loss Score at Week 16(Baseline, Week 16)
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2(Baseline to Week 2)
- Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1(Baseline to Week 1)
- Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
- Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)(Baseline, Week 16)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16(Baseline, Week 16)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults(Baseline, Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline, Week 16)
- Change From Baseline in PROMIS Depression at Week 16 - Adults(Baseline, Week 16)
- Change From Baseline in PROMIS Depression at Week 16 - Pediatrics(Baseline, Week 16)
- Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points(Baseline to Week 16)
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma(Baseline, Week 16)
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index(Baseline, Week 16)
- Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics(Baseline, Week 16)