A Phase 2，Multicenter, Randomized, Double-blind, Placebo-controlled，Multiple-dose Escalation and Dose Finding Study to Evaluate the Safety，PK and Efficacy of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 3
- 主要终点
- Incidence and severity of treatment emergent adverse event (TEAE).
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
详细描述
Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 Years to 65 Years, both male and female.
- •BMI ≥18 kg/m^2 and ≤32 kg/m^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.
- •Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..
- •Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=
- •According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
- •Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
排除标准
- •History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.
- •History of drug-induced psoriasis.
- •Ongoing use of prohibited treatments.
- •Have previously received any drug that directly targets IL-
- •Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.
- •Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.
- •Pregnant or lactating women.
研究组 & 干预措施
Part 1：608 40 mg
Randomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly.
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 1：608 40 mg
Randomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly.
干预措施: Placebo (Other)
Part 1：608 80 mg
Randomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly.
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W
Participants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).
干预措施: Placebo (Other)
Part 1：608 80 mg
Randomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly.
干预措施: Placebo (Other)
Part 1：608 160 mg
Randomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly.
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 1：608 160 mg
Randomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly.
干预措施: Placebo (Other)
Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W
Participants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 2：608 160 mg Q2W+160 mg Q4W
Participants will receive 160mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period followed by 160mg 608 once every four weeks (Q4W) during maintenance period.
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 2：608 160 mg Q4W+160 mg Q8W
Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.
干预措施: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection (Drug)
Part 2：608 160 mg Q4W+160 mg Q8W
Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.
干预措施: Placebo (Other)
Part 2：Placebo
Participants will receive Placebo by subcutaneous injection.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence and severity of treatment emergent adverse event (TEAE).
时间窗: Up to 64 Weeks
The incidence and severity of treatment emergent adverse event (TEAE), including adverse events (AEs)，serious adverse event (SAE) and AEs associated with the use of the drug, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.
次要结局
- AUC0-tau(Week 0 to 16)
- Rac_Cmax(week 0,12)
- Rac_AUC0-tau(week 0,12)
- Cmax(Week 0 to 16)
- Tmax(Week 0 to 16)
- Cmin(Week 0 to 48)
- AUC0-last(Week 0 to 16)
- Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.(Week 0,4,8,12,16,24,48,64)
- Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.(Week 0,8,20,44,64)
- Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)(At Week 12)
- Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement(At Week 12)
- Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)(At Week 12)
- Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)(At Week 12)