A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 835
- 试验地点
- 166
- 主要终点
- Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
研究概览
简要总结
This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 [adult studies] or M1095-HS-304 [adolescent study]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
- •Female participants are eligible to participate if they are not pregnant or breastfeeding
- •Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
排除标准
- •Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
- •Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
- •Participants who plan to participate in another interventional study for a drug or device during this study.
研究组 & 干预措施
Experimental: sonelokimab
All participants will receive sonelokimab 120 mg Q4W for up to 2 years
干预措施: Sonelokimab (Drug)
结局指标
主要结局
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
时间窗: 2.5-3 years
Incidence, relatedness, severity and seriousness of all AEs
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
时间窗: 2.5-3 years
Incidence, relatedness, severity and seriousness of all TEAEs
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
时间窗: 2.5-3 years
Incidence, relatedness, severity and seriousness of all AESIs
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
时间窗: 2.5-3 years
Number of participants discontinued from sonelokimab treatment due to AEs
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
时间窗: 2.5-3 years
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
时间窗: 2.5-3 years
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
次要结局
- Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)(2.5 - 3 years)
- Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)(2.5 - 3 years)
- Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)(2.5 - 3 years)
- Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules(2.5 - 3 years)
- Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)(2.5 - 3 years)
- Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)(2.5 - 3 years)