A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) 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
- 852
- 试验地点
- 136
- 主要终点
- Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
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 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
- •An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
- •Subject is male or female at least 18 years of age
- •Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
- •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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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
Bimekzumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
干预措施: Placebo (Other)
Bimekzumab dosage regimen
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
干预措施: Bimekizumab (Drug)
Adalimumab dosage regimen
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
干预措施: Adalimumab (Drug)
Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
干预措施: Placebo (Other)
Placebo
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
时间窗: Week 16
ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter \[mm\] 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), total 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) at Week 16 for Placebo and BKZ(Baseline, Week 16)
- Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline(Baseline, Week 4)
- Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline(Baseline, Week 16)
- Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ(Baseline, Week 16)
- Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16(Week 16)
- Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ(Baseline, Week 16)
- Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011(Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16)
- Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011(Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16)
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16(Week 16)
- Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ(Baseline, Week 16)
- Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16(Week 16)
- Percentage of Participants With 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, Week 4)
- Percentage of Participants With an 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, Week 16)
- Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16(Baseline, Week 16)
- Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline(Baseline, Week 16)
- Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16(Baseline, Week 16)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study(From Baseline until Safety Follow-Up (up to Week 72))
- Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study(From Baseline until Safety Follow-Up (up to Week 72))
- Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study(From Baseline until Safety Follow-Up (up to Week 72))