NCT07223138Enrolling By Invitation3 期
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 1,560
- 试验地点
- 17
- 主要终点
- Long-term safety and tolerability of sonelokimab:
研究概览
简要总结
This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)
详细描述
M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
- •Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.
- •Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
- •Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.
- •Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. 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 met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
- •Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
- •Participants who plan to participate in another interventional study for a drug or device during this study.
- •Participants who were unblinded during the parental study.
- •Participant noncompliance to the parental study
研究组 & 干预措施
Experimental: sonelokimab dose
Experimental
All participants will receive sonelokimab subcutaneously every 4 weeks
干预措施: Sonelokimab (Drug)
结局指标
主要结局
Long-term safety and tolerability of sonelokimab:
时间窗: 52 weeks
Treatment-emergent adverse events (TEAEs)
次要结局
- Long-term efficacy of sonelokimab:(52 weeks)
- Long term efficacy of sonelokimab(52 weeks)
研究者
研究点 (17)
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