A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 9
- 主要终点
- Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared with placebo.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participant must be at least 19 years of age at the time of signing the informed consent
- •Study participant must be a Korean adult with a diagnosis of moderate to severe psoriasis (PSO)
- •Study participant must have had plaque PSO for at least 6 months prior to the Screening Visit
- •Study participant must have Psoriasis Area and 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
- •Study participant must be a candidate for systemic PSO therapy and/or phototherapy
- •Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
- •A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a female of childbearing potential (FOCBP) OR A FOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 20 weeks after the last dose of study treatment
排除标准
- •Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent 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 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
- •Study participant has a presence of active suicidal ideation or positive suicide behavior
- •Study participant has a presence of moderately severe major depression or severe major depression
- •Subject has a known hypersensitivity to any excipients of bimekizumab
- •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
研究组 & 干预措施
Placebo arm
Study participants randomized to this arm will receive placebo (PBO) at pre-specified time points during the Treatment Period.
干预措施: Placebo (Other)
Bimekizumab arm
Study participants randomized to this arm will receive bimekizumab (BKZ; UCB4940) at pre-specified time points during the Treatment Period.
干预措施: bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With an Investigator's Global Assessment (IGA) 0/1 (Clear or Almost Clear With at Least 2-category Improvement From Baseline) Response at Week 16
时间窗: Week 16
The Investigator's Global Assessment measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= Clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= Almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= Mild, just detectable to mild thickening, pink to light red coloration and predominately fine scaling, scale 3= Moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and scale 4= Severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0/1 response was defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
时间窗: Week 16
The PASI90 response assessments are based on a 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. 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 the 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 an Investigator's Global Assessment (IGA) 0 (Clear With at Least 2-category Improvement From Baseline) Response at Week 16(Week 16)
- Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 4(Week 4)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study(From Baseline to End of Safety Follow-Up (SFU) (up to Week 32))
- Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Throughout the Study(From Baseline to End of Safety Follow-Up (up to Week 32))
- Percentage of Participants With TEAEs Leading to Permanent Discontinuation of Investigational Medicinal Product (IMP) Throughout the Study(From Baseline to End of Safety Follow-Up (up to Week 32))
- Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16(Week 16)
- Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Itch at Week 16(Week 16)
- Percent Change From Baseline in Body Surface Area (BSA) Affected by PSO at Week 16(Baseline, Week 16)
- Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Pain at Week 16(Week 16)
- Percentage of Participants With a Patient Symptom Diary (PSD) (P-SIM) Response for Scaling at Week 16(Week 16)
- Percentage of Participants With Scalp IGA Response 0/1 (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) at Week 16 for Study Participants With Scalp Psoriasis (PSO) at Baseline(Week 16)
- Percentage of Participants With Dermatology Life Quality Index (DLQI) 0/1 Response at Week 16(Week 16)
- Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) at Week 16(Baseline, Week 16)