NCT02763111已完成2 期
International Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing Spondylitis
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
- Biocad
- 入组人数
- 88
- 主要终点
- Ratio of patients with ASAS20 response after 16 weeks of therapy
研究概览
简要总结
BCD-085-3 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During the trial patients with active ankylosing spondylitis will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12. Efficacy and safety parameters will be evaluated.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age between 18 and 65 years
- •Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
- •Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
- •Mean backache intensity equals 4 points or more.
- •If patient have had biologic therapy to treat ankylosing spondylitis for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
- •Female patients have negative urine pregnancy test.
- •Patient has no history of tuberculosis.
- •Patients have negative results of Diaskintest.
- •Patient has no history of alcohol or drug abuse.
排除标准
- •Total spinal ankylosis.
- •Allergy or intolerance of monoclonal antibodies or any excipients of study drugs.
- •Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
- •Prior use of two or more biologics to tumor necrosis factor alfa.
- •Prior use of two or more biologics to other targets. Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
- •Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
- •Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization, if their dose was not stable for up to 4 weeks before signing informed consent and during screening.
- •Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
- •Prior use of alkylating agents for up to 12 months prior to signing informed consent.
- •Intraarticular use of corticosteroids for up to 4 weeks before randomization.
研究组 & 干预措施
BCD-085, 40 mg
Experimental
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
干预措施: BCD-085 (Drug)
BCD-085, 80 mg
Experimental
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
干预措施: BCD-085 (Drug)
BCD-085, 120 mg
Experimental
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
干预措施: BCD-085 (Drug)
Placebo
Placebo Comparator
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10, 12.
干预措施: Placebo (Other)
结局指标
主要结局
Ratio of patients with ASAS20 response after 16 weeks of therapy
时间窗: Week 16
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 16 weeks of therapy with BCD-085.
次要结局
- Frequency of local reactions(16 weeks)
- Frequency of AE/SAE 3-4 grade CTCAE 4.03(16 weeks)
- Proportion of patients with deterioration of roentgenologic signs of sacroileitis after 16 weeks of treatment(Week 16)
- Mean C-reactive protein concentration at screening and after 4, 8, 12 and 16 weeks of treatment.(Screening, Week 4, Week 8, Week 12, Week 16)
- Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy(Week 4, Week 8, Week 12, Week 16)
- Mean BASDAI score at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Mean chest excursion at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Frequency of AE/SAE(16 weeks)
- Ratio of patients with ASAS5/6 response after 4, 8, 12, 16 weeks of therapy(Week 4, Week 8, Week 12, Week 16)
- Mean MASES score at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Mean SF-36 score at screening and after 8 and 16 weeks of therapy(Screening, Week 8, Week 16)
- Т½(0 to 168 hours post-dose)
- Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy(Week 4, Week 8, Week 12)
- Cmin(0 to 168 hours post-dose)
- Cmax(0 to 168 hours post-dose)
- Proportion of patients who developed binding and neutralizing antibodies to BCD-085(16 weeks)
- Тmax(0 to 168 hours post-dose)
- Mean ASDAS-CRP score at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Mean pain score during a day at screening and after 1, 2, 4, 8, 12, 16 weeks of therapy(Screening, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16)
- Mean BASMI score at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Mean BASFI score at screening and after 4, 8, 12, 16 weeks of therapy(Screening, Week 4, Week 8, Week 12, Week 16)
- Frequency of withdrawals due to AE/SAE(16 weeks)
- AUC (0-168h)(0 to 168 hours post-dose)
- AUC0-∞(0 to 168 hours post-dose)
- Кel(0 to 168 hours post-dose)
- Cl(0 to 168 hours post-dose)
研究者
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