2025-522471-28-00招募中3 期
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Adverse events of special interest (AESIs)
研究概览
简要总结
To evaluate long-term safety and tolerability of sonelokimab in participants with PsA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 (EOT) visit (Week 52) 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 (WONCBP) or (if childbearing potential [WOCBP]) 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. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). 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. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications.
- •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.
- •Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator.
- •Participants are able to understand and provide signed informed consent, per local regulations and guidelines.
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 (significant violation of protocol requirements or any other instances as per investigator’s judgement).
结局指标
主要结局
Adverse events of special interest (AESIs)
Adverse events of special interest (AESIs)
Treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events (TEAEs)
Serious adverse events (SAEs)
Serious adverse events (SAEs)
TEAEs leading to study withdrawal
TEAEs leading to study withdrawal
Vital signs, and electrocardiogram (ECG) results
Vital signs, and electrocardiogram (ECG) results
Abnormal laboratory parameters (hematology, clinical chemistry)
Abnormal laboratory parameters (hematology, clinical chemistry)
次要结局
未报告次要终点
研究者
Clinical Trial Information Point
Scientific
MoonLake Immunotherapeutics AG
研究点 (3)
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