NCT02969525已完成2 期
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
UCB Biopharma S.P.R.L.40 个研究点 分布在 6 个国家目标入组 206 人开始时间: 2016年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 40
- 主要终点
- ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
研究概览
简要总结
This is a study to evaluate the dose response based on the efficacy, safety and tolerability of bimekizumab in subjects with active psoriatic arthritis.
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
- •Subject has a documented diagnosis of adult-onset PsA classified by Classification Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC) >=3 out of 76
- •Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- •Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
- •Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days before Baseline
- •Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose through the Week 16 visit
- •Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
- •Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
- •Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
- •experienced an inadequate response to previous treatment given for at least 3 months
- •been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation)
- •lost access to TNF inhibitor for other reasons
排除标准
- •Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
- •Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- •Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
- •Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- •Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
- •Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
- •Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
- •<= 3 excised or ablated basal cell carcinomas of the skin
- •One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
- •Actinic keratosis (-es)
- •Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
研究组 & 干预措施
Bimekizumab dosage regimen 3
Experimental
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 3.
干预措施: Bimekizumab (Drug)
Placebo
Placebo Comparator
Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
干预措施: Placebo (Other)
Bimekizumab dosage regimen 1
Experimental
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 1 and will then be re-randomized to Bimekizumab dosage regimen 2 or Bimekizumab dosage regimen 3 for 36 Weeks.
干预措施: Bimekizumab (Drug)
Bimekizumab dosage regimen 2
Experimental
Subjects will receive for 48 Weeks Bimekizumab dosage regimen 2.
干预措施: Bimekizumab (Drug)
Bimekizumab dosage regimen 4
Experimental
Subjects will receive for 12 Weeks Bimekizumab dosage regimen 4 and will then be re-randomized to Bimekizumab dosage regimen 2 for 36 Weeks.
干预措施: Bimekizumab (Drug)
结局指标
主要结局
ACR50 (American College of Rheumatology 50% Improvement) Response at Week 12
时间窗: Week 12
The ACR50 response rate was based on 50% improvement relative to Baseline in the following measures: * Tender Joint Count (TJC) based on 78 joints * Swollen Joint Count (SJC) based on 76 joints * 3 of the 5 remaining core set measures: * Disease activity as assessed by Patient's Global Assessment of Disease Activity (PGADA) * Disease activity as assessed by Physician's Global Assessment of Disease Activity (PhGADA) * Pain as assessed by Patient's Assessment of Arthritis Pain (PtAAP) * Physical function as assessed by Health Assessment Questionnaire - Disability Index (HAQ-DI) * Acute phase response as assessed by high sensitivity C-reactive protein (hs CRP).
次要结局
- ACR20 (American College of Rheumatology 20% Improvement) Response at Week 12(Week 12)
- PASI90 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1(Week 12)
- ACR70 (American College of Rheumatology 70% Improvement) Response at Week 12(Week 12)
- PASI75 (Psoriasis Area Severity Index) Response at Week 12 in the Subgroup of Subjects With Psoriasis Involving at Least 3 % Body Surface Area (BSA) at Baseline/Day 1(Week 12)
- Percentage of Participants With at Least One Adverse Event (AE) During the Study(From Screening Period until the Safety Follow-Up Visit (up to Week 72))
- Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study(From Screening Period until the Safety Follow-Up Visit (up to Week 72))
- Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study(From Screening Period until the Safety Follow-Up Visit (up to Week 72))
- Changes From Baseline in Vital Signs During the Study (Diastolic Blood Pressure, Systolic Blood Pressure)(Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48)
- Changes From Baseline in Vital Signs During the Study (Pulse Rate)(Baseline, 30 min and 1 hour post dose, Week 1, Week 2, pre- and post dose for the following Weeks: 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 and Week 48)
- Changes From Baseline in Body Weight During the Study(Baseline, Week 12, Week 24, Week 36 and Week 48)
- Changes From Baseline in Electrocardiogram (ECG) Intervals During the Study (QTcB, QTcF, PR, QRS, QT, RR)(Baseline, Week 12 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Hemoglobin (HGB))(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Erythrocytes Mean Corpuscular Volume)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Erythrocytes)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Hematocrit)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Hematology Parameters During the Study (Platelets)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Biochemistry Parameters During the Study (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Biochemistry Parameters During the Study (Albumin)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Biochemistry Parameters During the Study (Bilirubin, Creatinine, Urate)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Biochemistry Parameters During the Study (Calcium, Chloride, Cholesterol, Glucose, Magnesium, Potassium, Sodium)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Biochemistry Parameters During the Study (Urea Nitrogen)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Urinalysis Parameters During the Study (Erythrocytes, Leukocytes, Renal Epithelial Casts, Squamous Epithelial Cells, Transitional Epithelial Cells)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Urinalysis Parameters During the Study (Hyaline Casts)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
- Changes From Baseline in Urinalysis Parameters During the Study (pH)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48)
研究者
研究点 (40)
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