A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab 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
- Enrolling By Invitation
- 入组人数
- 333
- 试验地点
- 188
- 主要终点
- Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis.
This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All participants receive Lebrikizumab during the 16-week blinded treatment period. At Week 18, participants receive open-label lebrikizumab. From Week 52 onward, doses may be blinded or open-label.
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
- •For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- •Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- •Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
- •Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
- •Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
研究组 & 干预措施
Lebrikizumab
Participants will receive Lebrikizumab administered subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
干预措施: Placebo (Drug)
Lebrikizumab - Optional Extension Period (OEP)
During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
干预措施: Lebrikizumab (Drug)
Lebrikizumab
Participants will receive Lebrikizumab administered subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
干预措施: Lebrikizumab (Drug)
Lebrikizumab - Optional Extension Period (OEP)
During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
时间窗: Baseline through Week 52
次要结局
- Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ(Baseline to Week 52)
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score(Baseline, Week 52)
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI(Baseline, Week 52)
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ(Baseline to Week 52)
- Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ(Baseline to Week 52)
- Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)(Baseline, Week 52)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ(Baseline to Week 52)
- Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)(Baseline, Week 52)
- Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI(Baseline, Week 52)