A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%
研究概览
简要总结
This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old;
- •Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
- •Received previous biologic therapy with at least 4 months.
排除标准
- •Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
- •Previously treated with IBI112 or other IL-23 inhibitors;
- •Treated with two biologics for psoriasis within 4 months prior to screening;
- •Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
- •Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
- •Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
- •Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.
研究组 & 干预措施
Response to previous biologic therapy
Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36.
干预措施: regular treatment (Drug)
Poor response to previous biologic therapy
Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32.
干预措施: Intensive treatment (Drug)
结局指标
主要结局
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%
时间窗: Week 16
次要结局
- Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.(Week 44)
- Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44(Week 16 up to Week 44)
- Percentage of participants who achieve sPGA clean (0) at Week 16.(Week 16)
- Percentage of participants with a DLQI score of 0/1 at Week 16.(Week 16)