A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 377
- 试验地点
- 169
- 主要终点
- Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
研究概览
简要总结
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
- •12 months if participants are ≥6 years of age
- •6 months if participants are 2 to <6 years of age
- •3 months if participants are 6 months to <2 years of age.
- •Have an EASI score ≥16 at the screening and baseline
- •Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
- •Have ≥10% BSA of AD involvement at the screening and baseline.
排除标准
- •Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Treatment with the following prior to the baseline:
- •An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
- •Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%.
- •Treatment with a topical investigational drug within 2 weeks prior to the baseline.
- •Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
研究组 & 干预措施
Lebrikizumab (Cohort 2)
Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.
Dosing will be based on weight.
干预措施: Topical Corticosteroid (TCS) (Drug)
Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
干预措施: Placebo (Drug)
Lebrikizumab (Cohort 1)
Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).
Dosing will be based on weight.
干预措施: Topical Corticosteroid (TCS) (Drug)
Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
干预措施: Topical Corticosteroid (TCS) (Drug)
Lebrikizumab (Cohort 1)
Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).
Dosing will be based on weight.
干预措施: Lebrikizumab (Drug)
Lebrikizumab (Cohort 2)
Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.
Dosing will be based on weight.
干预措施: Lebrikizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
时间窗: Baseline to Week 16
IGA is a co-primary endpoint with EASI-75.
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
时间窗: Baseline to Week 16
EASI-75 is a co-primary endpoint with IGA.
次要结局
- Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score(Baseline to Week 16)
- Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline(Baseline to Week 16)
- Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16(Baseline to Week 16)
- Percentage Change from Baseline in EASI Score(Baseline, Week 16)
- Percentage Change from Baseline in Pruritus NRS Score(Baseline, Week 16)
- Change from Baseline in Body Surface Area (BSA)(Baseline, Week 16)
- Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)(Baseline, Week 16)
- Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score(Baseline to Week 16)
- Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration(Week 14)
- Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)(Week 14)
- Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score(Baseline to Week 16)
- Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline(Baseline to Week 16)
- Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16(Baseline to Week 16)
- Percentage Change from Baseline in EASI Score(Baseline, Week 16)
- Percentage Change from Baseline in Pruritus NRS Score(Baseline, Week 16)
- Change from Baseline in Children Dermatology Life Quality Index (cDLQI)(Baseline, Week 16)
- Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)(Baseline, Week 16)
- Change from Baseline in Body Surface Area (BSA)(Baseline, Week 16)
- Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)(Baseline, Week 16)
- Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score(Baseline to Week 16)
- Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration(Week 14)
- Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)(Week 14)
- Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16(Baseline to Week 16)
- Change from Baseline in SCORAD(Baseline, Week 16)