International Multi-center Comparative Randomized Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Patients With PASI 75 Response After 12 Weeks of Therapy
研究概览
简要总结
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. 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
- •Diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study.
- •Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment.
- •BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥
- •If patient have had biologic therapy 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.
- •Patients are able to perform all procedures planed by protocol.
- •Patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug.
排除标准
- •Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
- •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 drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, 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 phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent.
研究组 & 干预措施
BCD-085, 40 mg
Patient will receive 40 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
干预措施: BCD-085 (Drug)
BCD-085, 80 mg
Patient will receive 80 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
干预措施: BCD-085 (Drug)
BCD-085, 120 mg
Patient will receive 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
干预措施: BCD-085 (Drug)
Placebo
Patient will receive placebo subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Patients With PASI 75 Response After 12 Weeks of Therapy
时间窗: 12 weeks
The PASI allows evaluating the extent and severity of skin symptoms of psoriasis. Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI: 0 (no disease) to 72 (maximal disease). The proportion of patients with PASI 75 was defined as patients achieving 75% or more improvement at Week 12 of therapy with BCD-085 from baseline.
次要结局
- Number of Patients With sPGA Response After 4, 8, 12 Weeks of Treatment With BCD-085(Week 4, Week 8, Week 12)
- Relative Change in PASI Score After 4, 8 and 12 Weeks of Therapy With BCD-085(Week 4, Week 8, Week 12)
- Mean Change in Severity of Pruritus Assessed by Visual Analog Scale After 1, 4, 8 and 12 Weeks of Treatment With BCD-085(Week 1, Week 4, Week 8, Week 12)
- Frequency of AE/SAE(14 weeks)
- Number of Patients With PASI50 and PASI90 Response After 4, 8 and 12 Weeks of Therapy(Week 4, Week 8, Week 12)
- Relative Change in BSA After 4, 8 and 12 Weeks of Therapy With BCD-085(Week 4, Week 8, Week 12)
- Number of Patients With PASI75 Response After 4 and 8 Weeks of Therapy(Week 4, Week 8)
- Relative Change in NAPSI Score After 12 Weeks of Therapy With BCD-085(Week 12)
- Mean Change in Quality of Life Assessed by DLQI After 4, 8 and 12 Weeks of Treatment With BCD-085(Week 4, Week 8, Week 12)
- Frequency of Withdrawal Due to AE/SAE(14 weeks)
- Mean Change in Quality of Life Assessed by SF-36 After 4, 8 and 12 Weeks of Treatment With BCD-085(Week 4, Week 8, Week 12)
- Frequency of AE/SAE Grade 4 CTCAE 4.03(14 weeks)
- Frequency of Local Reactions(14 weeks)