A Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (1311.5)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).
详细描述
Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; the lead-in study) were eligible to enroll in M16-244 (this study). Participants were allowed to either finish the Week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.
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 have completed all doses of study drug and Week 24 visit of the lead-in study.
- •Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given.
- •Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
- •Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures.
- •Participant is judged to be in good health as determined by the Investigator.
排除标准
- •Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given.
- •Premature discontinuation of the study drug in the lead-in study for any reason.
- •Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study.
- •Time elapsed is > 8 weeks since the Week 24 visit in the lead-in study.
- •Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer
次要结局
- Percentage of Participants Achieving ACR20 Response at Week 24(Week 24)
- Percentage of Participants Achieving ACR20 Response at Week 4(Week 4)
- Percentage of Participants Achieving ACR20 Response at Week 36(Week 36)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24(Baseline (Lead-in Study), Week 24)
- Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study(Baseline (Lead-in Study), Week 24 (Lead-in Study))
- mTSS: Change From Baseline (in the Lead-in Study) to Week 48(Baseline (Lead-in Study), Week 48)
- Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0(Baseline (Lead-in Study), Week 0)
- Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0(Baseline (Lead-in Study), Week 0)
- mTSS: Change From Baseline (in the Lead-in Study) to Week 24(Baseline (Lead-in Study), Week 24)
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0(Week 0)
- Percentage of Participants Achieving ACR20 Response at Week 48(Week 48)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4(Baseline (Lead-in Study), Week 4)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12(Baseline (Lead-in Study), Week 12)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36(Baseline (Lead-in Study), Week 36)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48(Baseline (Lead-in Study), Week 48)
- Percentage of Participants Achieving ACR20 Response at Week 12(Week 12)
- Percentage of Participants Achieving ACR20 Response at Week 52(Week 52)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12(Baseline (Lead-in Study), Week 12)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12(Baseline (Lead-in Study), Week 12)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36(Baseline (Lead-in Study), Week 36)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48(Baseline (Lead-in Study), Week 48)
- HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52(Baseline (Lead-in Study), Week 52)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24(Baseline (Lead-in Study), Week 24)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36(Baseline (Lead-in Study), Week 36)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4(Baseline (Lead-in Study), Week 4)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24(Baseline (Lead-in Study), Week 24)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4(Baseline (Lead-in Study), Week 4)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48(Baseline (Lead-in Study), Week 48)
- SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0(Baseline (Lead-in Study), Week 0)
- SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52(Baseline (Lead-in Study), Week 52)
- SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52(Baseline (Lead-in Study), Week 52)