A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,170
- 试验地点
- 233
- 主要终点
- Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.
详细描述
This is a Phase 3, single-arm, multicenter open label extension (OLE) study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. Approximately 2200 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.
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 with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
- •Participants must be candidates for prolonged open label risankizumab treatment according to investigator judgment.
- •Females of childbearing potential must have a negative urine pregnancy test result at Baseline.
- •If female, participant must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control, starting at Baseline through at least 20 weeks after the last dose of study drug.
- •Participants must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.
排除标准
- •Premature discontinuation for any reason in the preceding study.
- •Participants who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.
- •Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
- •Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ECG), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data.
- •Previous enrollment in this study.
- •Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug.
- •Time elapsed is > 8 weeks since the completion visit in the preceding study.
- •Participant is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
研究组 & 干预措施
Risankizumab
Participants will receive risankizumab administered by subcutaneous injection.
干预措施: risankizumab (Biological)
结局指标
主要结局
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
时间窗: Median follow-up time of 1905 days
An adverse event 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 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.
次要结局
未报告次要终点