A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety 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
- 743
- 试验地点
- 144
- 主要终点
- Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
研究概览
简要总结
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
详细描述
The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Double-blind Treatment Period
- •Male or female at least 18 years of age
- •Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
- •Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5 point scale
- •Subject must be a candidate for systemic PSO therapy and/or phototherapy
- •Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
- •Female subject of childbearing potential must be willing to use highly effective method of contraception
- •Open-label extension (OLE) Period
- •Completed the double-blind Treatment Period without meeting any withdrawal criteria
- •All Week 48 visit assessments completed
- •Compliant with ongoing clinical study requirements
- •Signed a separate OLE Period Informed Consent Form (ICF)
- •Female subject of childbearing potential must be willing to use highly effective method of contraception
- •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
- •Double-blind Treatment Period
- •Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
- •Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- •Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
- •Presence of active suicidal ideation or severe depression
- •Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
- •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 dosage regimen 2
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Bimekizumab (Drug)
Bimekizumab dosage regimen 1
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).
At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Placebo (Other)
Bimekizumab dosage regimen 2
Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Placebo (Other)
Bimekizumab dosage regimen 1
Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).
At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Bimekizumab (Drug)
Secukinumab
Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Secukinumab (Drug)
Secukinumab
Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
时间窗: Week 16
The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
次要结局
- Percentage of Participants With a PASI75 Response at Week 4(Week 4)
- Percentage of Participants With a PASI90 Response at Week 16(Week 16)
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225(From Baseline up to Week 225)
- Percentage of Participants With a PASI100 Response at Week 48(Week 48)
- Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16(Week 16)
- Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225(From Baseline up to Week 225)
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225(From Baseline up to Week 225)