A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 92
- 主要终点
- Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
研究概览
简要总结
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
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
- Triple (Participant, 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
- •Subject is male or female at least 18 years of age
- •Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
- •Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
- •Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
- •Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
- •Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
- •Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
排除标准
- •Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- •Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
- •Subject has an active infection or a history of recent serious infections
- •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 a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
- •Subject had acute anterior uveitis within 6 weeks of Baseline
- •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
- •Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
- •Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- •Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
研究组 & 干预措施
Placebo
Subjects randomized to this arm will receive placebo.
干预措施: Placebo (Other)
Bimekizumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response
时间窗: From Baseline to Week 16
The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity \[100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)\], Patient global assessment of disease activity \[100 mm VAS (0=no limitation of normal activities;100=very poor\], Patient assessment of pain \[100 mm VAS (0=no pain;100=most severe pain)\], Health Assessment Questionnaire - Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP).
次要结局
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16(Baseline and Week 16)
- Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline(From Baseline to Week 4)
- Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline(From Baseline to Week 16)
- Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16(Baseline and Week 16)
- Minimal Disease Activity (MDA) at Week 16(Week 16)
- Percentage of Participants With American College of Rheumatology 20 (ACR20) Response(From Baseline to Week 16)
- Percentage of Participants With American College of Rheumatology 70 (ACR70) Response(From Baseline to Week 16)
- Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline(Baseline and Week 4)
- Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline(Baseline and Week 16)
- Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16(Baseline and Week 16)
- Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16(Baseline and Week 16)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study(From Baseline until Safety Follow-Up (up to 37 weeks))
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study(From Baseline until Safety Follow-Up (up to 37 weeks))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study(From Baseline until Safety Follow-Up (up to 37 weeks))