A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,353
- 试验地点
- 378
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
研究概览
简要总结
This is a study to evaluate the long-term safety and tolerability of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis (PSO).
详细描述
The study consists of a 144-week Treatment Period (open-label) and an optional 48-week Open-Label Extension Period 2 (OLE2) for eligible subjects in the USA and Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Treatment Period (open-label)
- •Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
- •Subject completes the feeder study (PS0008 [NCT03412747], PS0009 [NCT03370133], PS0013 [NCT03410992]) without meeting any withdrawal criteria
- •Female subjects must be:
- •Postmenopausal: Menopause is defined as 12 consecutive months of amenorrhea, for which there is no other obvious pathological or physiological cause
- •Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
- •Or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception throughout the duration of the study until 20 weeks after last administration of investigational medicinal product (IMP), and have a negative pregnancy test at the feeder study in final visit/Baseline visit in PS0014
- •OLE2 Period (USA and Canada)
- •Completed the OLE Period without meeting any withdrawal criteria
- •Compliant with ongoing clinical study requirements
- •Female subject of childbearing potential must be willing to use highly effective method of contraception
- •Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
- •Signed a separate OLE2 Period ICF
排除标准
- •Treatment Period (open-label)
- •Subject has previously participated in this study
- •Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication
- •Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing Serious Adverse Event (SAE), or a history of serious infections in the feeder study, the Medical Monitor must be consulted prior to the subject's entry into PS0014, although the decision on whether to enroll the subject remains with the Investigator
- •Subject has a positive or indeterminate interferon gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
- •Subject may not participate in another study of a medicinal product or device under investigation other than the substudy
- •Subject has a history of chronic alcohol or drug abuse within 6 months prior to Baseline as assessed by medical history, site interview, and/or results of the specified urine drug screen
- •OLE2 Period (USA and Canada)
- •Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
- •Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
- •Presence of active suicidal ideation or severe depression
- •Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
研究组 & 干预措施
Bimekizumab dose regimen 2
Subjects are randomized to receive BKZ 2 during the 144-week Treatment Period (open-label).
Eligible subjects who completed the Treatment Period (open-label), would continue OLE2 on BKZ 2.
Intervention Name: Bimekizumab
干预措施: Bimekizumab (Drug)
Bimekizumab dose regimen 1
Subjects are randomized to receive either dose regimen 1 (BKZ 1) or dose regimen 2 (BKZ 2) during the 144-week Treatment Period (open-label), those on BKZ 1 will switch to BKZ 2 at Week 24 or later (at the next scheduled clinic visit after Week 48)
Eligible subjects who completed the Treatment Period (open-label), and have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks.
Intervention Name: Bimekizumab
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP)
时间窗: From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period
The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
次要结局
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP(From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period)
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP(From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period)
- Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation)(Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B)
- Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case)(Week 144 compared to Baseline of PS0014 for Cohort B)
- Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation)(Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B)
- Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case)(Week 144 for Cohort B EP and GPP groups)