NCT04921345已完成2 期
A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 109
- 试验地点
- 46
- 主要终点
- Nemolizumab Serum Concentrations of Pediatric Participants
研究概览
简要总结
The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
- •EASI score >=16 at both screening and baseline visits
- •IGA score >=3 at both screening and baseline visits
- •AD involvement >=10% of BSA at both screening and baseline visits
- •Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
- •Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
- •Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
- •Other protocol defined inclusion criteria could apply
排除标准
- •Body weight less than 10 kilogram (kg)
- •Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
- •Participants with a current medical history of chronic bronchitis
- •Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
- •Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction [PCR]), or human immunodeficiency virus (HIV) antibody at the screening visit
- •History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
- •Known or suspected immunosuppression
- •Participants unwilling to refrain from using prohibited medications during the clinical trial.
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Cohort 1.1: Participants aged 7-11 years
Experimental
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
干预措施: Nemolizumab (Drug)
Cohort 2: Participants aged 2-6 years
Experimental
Participants aged 2-6 years will receive nemolizumab for 52 weeks.
干预措施: Nemolizumab (Drug)
Cohort 1: Participants aged 7-11 year
Experimental
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
干预措施: Nemolizumab (Drug)
结局指标
主要结局
Nemolizumab Serum Concentrations of Pediatric Participants
时间窗: At Week 4, 8, 12, 16, 32 and 52
Apparent Volume of Distribution (Vd/F) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Apparent Terminal Half-life (t1/2) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Number of Participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Adverse Events Leading to Discontinuation and Serious Adverse Events (SAEs)
时间窗: Baseline through Week 52
Apparent Total Body Clearance (Cl/F) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Absorption Rate Constant (Ka) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
Maximum Observed Serum Concentration (Cmax) of Nemolizumab
时间窗: At Week 4, 8, 12, 16, 32 and 52
次要结局
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Number of Participants Achieving 50%, 75% or 90% Response From Baseline in Eczema Area and Severity Index (EASI-50, EASI-75 and EASI-90) at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Investigator's Global Assessment (IGA) Success Rate at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Change From Baseline in Body Surface Area (BSA) Involvement by Atopic Dermatitis (AD)(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Percent Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of Participants With an Improvement of >= 4 From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Percent Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Absolute Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Percent Change From Baseline in Weekly Average of Sleep Disturbance Numeric Rating Scale (NRS) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of Participants Receiving any Rescue Therapy by Rescue Treatment(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Each Visit up to Week 52(Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) For Participants >=4 Years of Age up to Week 16 and Week 52(Baseline, Week 16 and Week 52)
- Change From Baseline in Infants' Dermatology Life Quality Index (iDLQI) For Participants <4 Years of Age From Baseline up to Week 16 and up to Week 52(Baseline, Week 16 and Week 52)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM) up to Week 16 and Week 52(Baseline, Week 16 and Week 52)
- Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Peak Pruritus Numeric Rating Scale (PP NRS)(Baseline, Week 16 and Week 52)
- Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Eczema Area and Severity Index (EASI) Score(Baseline, Week 16 and Week 52)
- Pharmacokinetic (PK)/Pharmacodynamic (PD) Relationship Between Nemolizumab Serum Concentration and Changes in Investigator's Global Assessment (IGA) Score(Baseline, Week 16 and Week 52)
- Number of Participants with Positive Anti-Drug Antibody (ADA) for Nemolizumab(Baseline, Week 16 and Week 52)
研究者
研究点 (46)
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