NCT04146363已完成3 期
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in 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
- 424
- 试验地点
- 186
- 主要终点
- Percentage of Participants With an Investigator 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 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
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)
盲法说明
Double-blind
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 adults and adolescents (≥12 years and ≥40 kg)
- •Chronic atopic dermatitis (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 atopic dermatitis 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
- •Prior treatment with dupilumab or tralokinumab
- •Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
- •Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- •Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •Phototherapy and photochemotherapy (PUVA) for AD
- •Treatment with the following prior to the baseline visit:
- •An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
- •Cell-depleting biologics, including to rituximab, within 6 months of baseline
- •Other biologics within 5 half-lives (if known) or 16 weeks of baseline, 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, e.g., co-morbid severe uncontrolled asthma
- •Evidence of active acute or chronic hepatitis
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology
- •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 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 Atopic Dermatitis (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 in EASI Score) From Baseline to Week 16
时间窗: Baseline to Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin 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-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 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 an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4(Baseline to Week 4)
- Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults(Baseline to Week 16)
- Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2(Baseline to Week 2)
- Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1(Baseline to Week 1)
- Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52(Baseline to Week 52)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2(Baseline to Week 2)
- Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16(Baseline, Week 16)
- Percent Change in EASI Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving EASI-90 From Baseline to Week 4(Baseline to Week 4)
- Percent Change in Sleep-loss Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
- Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52(Predose: Baseline, Week 4, Week 16, Week 32, Week 52)
- Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16(Baseline to Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16(Baseline to Week 16)
- Change From Baseline in Sleep-loss Score at Week 16(Baseline, Week 16)
- Percentage of Participants With a Pruritus NRS Score 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 Score 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 Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
- Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit and IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52(Baseline to Week 52)
- Change From Baseline in Percent Body Surface Area (BSA) at Week 16(Baseline, Week 16)
- Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index(Baseline, Week 16)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents(Baseline, Week 16)
- Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52(Baseline, Week 52)
- Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)(Baseline, Week 16)
- Change From Baseline in PROMIS Depression at Week 16 - Adults(Baseline, Week 16)
- Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)(Baseline to Week 52)
- Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52(Baseline to Week 52)
- Change From Baseline in PROMIS Depression at Week 16 - Adolescents(Baseline, 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 Patient Oriented Eczema Measure (POEM) at Week 16(Baseline, Week 16)
- Change From Baseline in PROMIS Anxiety at Week 16 - Adults(Baseline, Week 16)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents(Baseline, Week 16)
研究者
研究点 (186)
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