A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period 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
- 435
- 试验地点
- 128
- 主要终点
- Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
研究概览
简要总结
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.
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
- •Must be at least 18 years of age
- •Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
- •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 is a candidate for systemic PSO therapy and/or phototherapy
- •Female subject of child bearing potential must be willing to use highly effective method of contraception
排除标准
- •Subject has an active infection (except common cold), a recent 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 positive suicide behavior
- •Presence of moderately severe major depression or severe major 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
研究组 & 干预措施
Placebo
Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.
干预措施: Placebo (Other)
Bimekizumab cohort
Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
干预措施: Placebo (Other)
Bimekizumab cohort
Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
干预措施: Bimekizumab (Drug)
Bimekizumab Escape arm
Subjects who do not achieve certain predefined response criteria at Week 16 or later will enter the bimekizumab escape arm and will receive open-label bimekizumab for 12 weeks.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
时间窗: At Week 16
A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16
时间窗: At Week 16
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-Inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI).
次要结局
- Percentage of Participants With a IGA Clear Response at Week 16(At Week 16)
- Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16(At Week 16)
- Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders(At Week 56)
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period(From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration))
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period(From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration))
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment(From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration))
- Percentage of Participants With a PASI75 Response at Week 4(At Week 4)
- Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16(At Week 16)
- Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period(From Baseline to end of Initial Treatment Period (up to Week 16))
- Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period(From Baseline to end of Initial Treatment Period (up to Week 16))
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period(From Baseline to end of Initial Treatment Period (up to Week 16))
- Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period(From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration))
- Percentage of Participants With a PASI100 Response at Week 16(At Week 16)
- Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16(At Week 16)
- Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline(At Week 16)
- Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment(From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration))
- Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment(From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration))