An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 19
- 主要终点
- Pharmacokinetics (PK) of sonelokimab in adolescents
研究概览
简要总结
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent.
- •Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent.
- •Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
- •Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
- •Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
- •Participants with a body weight of ≥ 40 kg.
排除标准
- •Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- •Participants with a draining fistula count of ≥20 at the Screening Visit.
- •Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- •Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
- •Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
- •Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
- •Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
研究组 & 干预措施
sonelokimab
Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8
干预措施: Sonelokimab (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of sonelokimab in adolescents
时间窗: Week 24
PK (trough concentrations) of sonelokimab over 24 weeks of treatment
Adverse events (AEs) following treatment with sonelokimab in adolescents
时间窗: Week 24
Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
Discontinuation of sonelokimab treatment due to AEs
时间窗: Week 24
Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
Clinically significant changes in clinical laboratory parameters
时间窗: Week 24
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Clinically significant changes in vital signs
时间窗: Week 24
Number of participants with clinically significant changes in vital signs from baseline
Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
时间窗: Week 24
Number of participants with clinically significant changes in 12-lead ECG intervals from baseline
次要结局
- Hidradenitis Suppurativa Clinical Response (HiSCR)75(Week 24)
- Hidradenitis Suppurativa Clinical Response (HiSCR) 50(Week 24)
- International Hidradenitis Suppurativa Severity Score System (IHS4)(Week 24)
- Children's Dermatology Life Quality Index (CDLQI)(Week 24)
- Numerical Rating Scale (NRS) 30(Week 24)