A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis
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)
盲法说明
Participant, Care Provider, Investigator
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
- •Have a diagnosis of plaque-type psoriasis for at least 6 months;
- •Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
- •Must be a candidate for either systemic therapy or phototherapy for psoriasis.
排除标准
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- •Participants who have ever received IBI112 or IL-23 inhibitor
- •History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
- •Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
研究组 & 干预措施
Group 3
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44
干预措施: IBI112 (Drug)
Group 4
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44
干预措施: IBI112 (Drug)
Group 6
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44
干预措施: IBI112 (Drug)
Group 5
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
干预措施: IBI112/placebo (Drug)
Group 1
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44
干预措施: IBI112 (Drug)
Group 2
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44
干预措施: IBI112/placebo (Drug)
结局指标
主要结局
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
时间窗: Week 56
次要结局
- Percentage of participants with a sIGA score of 0(Week 56)
- Percentage of participants with a PASI100 Response(Week 56)
- Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response(Week 56)
- Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1(Week 56)
- Percentage of participants with Dermatology Life Quality Index (DLQI) Score(Week 56)
- Changes of PASI Scores participants who relapse and retreatment(Week 56)
- Percentage of participants with a PASI75 Response(Week 56)
- Changes of sIGA score in participants who relapse and retreatment(Week 56)