NCT02804763已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
UCB Biopharma S.P.R.L.71 个研究点 分布在 9 个国家目标入组 182 人开始时间: 2016年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 71
- 主要终点
- Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
研究概览
简要总结
The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.
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
- •Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by Systemic Lupus International Collaborating Clinics (SLICC) classification criteria
- •Moderate to severe SLE disease activity
- •Evidence for at least 1 of the following SLE markers:
- •Anti-dsDNA antibodies confirmed by central laboratory or
- •Low complement confirmed by central laboratory or
- •Antinuclear antibody (ANA) titer of >= 1:80 in combination with at least 1 of the following: Historical positivity for anti-dsDNA or Positivity for extractable nuclear antigen (anti-ENA) confirmed by central laboratory
- •The subject is receiving stable SLE standard-of-care medication
排除标准
- •Mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE
- •Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments.
- •New or worsening Class III or IV lupus nephritis
- •Chronic kidney failure stage 3b
- •Evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
- •Clinically significant active or latent infection (eg. chronic viral hepatitis B or C)
- •Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection
- •Live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug
- •History of thromboembolic events within 12 months of screening
- •Subject has used protocol defined prohibited medications
研究组 & 干预措施
DZP dose 2
Experimental
Dapirolizumab pegol (DZP) dose 2 in a specified sequence for a total of 24 weeks
干预措施: Dapirolizumab pegol (DZP) (Drug)
Placebo
Placebo Comparator
Placebo in a specified sequence for a total of 24 weeks
干预措施: Placebo (Drug)
DZP dose 1
Experimental
Dapirolizumab pegol (DZP) dose 1 in a specified sequence for a total of 24 weeks
干预措施: Dapirolizumab pegol (DZP) (Drug)
DZP dose 3
Experimental
Dapirolizumab pegol (DZP) dose 3 in a specified sequence for a total of 24 weeks
干预措施: Dapirolizumab pegol (DZP) (Drug)
结局指标
主要结局
Percentage of Participants With British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-Based Composite Lupus Assessment (BICLA) (mNRI) Response Across 3 Doses of Dapirolizumab Pegol (DZP) and Placebo (PBO) at Week 24
时间窗: Week 24
The primary efficacy variable was assessed by establishing if there was a dose response relationship between BICLA response at Week 24 and dose, using Multiple Comparison Procedure - Modelling (MCP-Mod). Four candidate dose-response models were evaluated: a linear model, a logistic model, and 2 Emax models, and the MCP-Mod methodology controlled for multiplicity. BICLA response was defined as meeting all of the following criteria: 1. BILAG 2004 improvement: A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B. 2. No worsening in Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K), defined as no increase in SLEDAI-2K total score. 3. No worsening in Physician's Global Assessment of Disease Activity (PGA), defined as \< 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). 4. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants, and antimalarials.
次要结局
- Mean Change From Baseline in Diastolic Blood Pressure(From Baseline (Week 1) to Week 48)
- Percentage of Participants Who Permanently Withdrew of Study Drug Due to an Adverse Event (AE)(From Baseline (Week 1) until end of the study (Week 48))
- Mean Change From Baseline in Erythrocytes(From Baseline (Week 1) to Week 48)
- The Percentage of Participants With BICLA (mNRI) Response in the Individual Dose Groups at Week 24(Week 24)
- Percentage of Participants With at Least One Adverse Events (AEs)(From Baseline (Week 1) until end of the study (Week 48))
- Mean Change From Baseline in Systolic Blood Pressure(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Eosinophils/Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Basophils/Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Pulse Rate(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Temperature(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Weight(Baseline (Week 1), Week 4, Week 8, Week 12, Week 16, and Week 20)
- Mean Change From Baseline in Hemoglobin(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Hematocrit(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Basophils(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Phosphate(From Baseline (Week 1) to Week 48)
- Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormal Findings(Screening, Week 4, Week 24, Week 28 and Week 48)
- Percentage of Participants With a Serious Adverse Event (SAE)(From Baseline (Week 1) until end of the study (Week 48))
- Mean Change From Baseline in Creatinine(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Sodium(From Baseline (Week 1) to Week 48)
- Percentage of Participants With at Least One Adverse Events (AEs) of Interest(From Baseline (Week 1) until end of the study (Week 48))
- Mean Change From Baseline in Height(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Alkaline Phosphatase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Albumin(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Triglycerides(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Erythrocytes Mean Corpuscular Volume(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Neutrophils(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Neutrophils/Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in CD3/Lymphocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Bilirubin(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Lactate Dehydrogenase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Urea Nitrogen(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Cholesterol(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Protein(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Creatine Kinase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Calcium(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Eosinophils(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Lymphocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Cluster of Differentiation 19 (CD19)(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Aspartate Aminotransferase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Alanine Aminotransferase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Gamma Glutamyl Transferase(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Potassium(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Lipase, Pancreatic(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in pH(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Leukocytes (/HPF)(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Lymphocytes/Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Monocytes/Leukocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Platelets(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Cluster of Differentiation 3 (CD3)(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Direct Bilirubin(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Monocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in CD19/Lymphocytes(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Glucose(From Baseline (Week 1) to Week 48)
- Mean Change From Baseline in Erythrocytes (/HPF)(From Baseline (Week 1) to Week 48)
研究者
研究点 (71)
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