NCT05645627已完成3 期
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of participants with moderate to severe plaque-type 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
- •Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
排除标准
- •History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- •Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- •Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent
- •Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
- •Has received any conventional therapeutic agent within 1 months of the first administration of study agent
- •Has received any topic therapeutic agent within 2 weeks of the first administration of study agent
研究组 & 干预措施
Group 1
Placebo Comparator
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
干预措施: placebo /IBI112 (Drug)
Group 2
Experimental
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
干预措施: IBI112 (Drug)
Group 3
Experimental
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48
干预措施: IBI112 (Drug)
结局指标
主要结局
Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
时间窗: Week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
时间窗: Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe
次要结局
- Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16(Week 16)
- Change from Baseline in Dermatology life quality index(DLQI) at week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16(Week 16)
- Change from Baseline in Dermatology life quality index(DLQI) at week 16(Week 16)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52(Week 52)
- Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16(Week 16)
- Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52(Week 52)
- Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52(Week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque PsoriasisPsoriasisNCT05003531Innovent Biologics (Suzhou) Co. Ltd.250
已完成
3 期
IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatmentPsoriasisNCT06049810Innovent Biologics (Suzhou) Co. Ltd.566
终止
2 期
BIIB023 Proof-of-Concept Study in Participants With Lupus NephritisLupus NephritisNCT01499355Biogen276
已完成
3 期
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2Hepatitis C, ChronicNCT01728324Boehringer Ingelheim496
Unknown
1 期
Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)DLBCLNCT05039658Innovent Biologics (Suzhou) Co. Ltd.50
相关资讯
China Approves First Domestic IL-23p19 Antibody for Psoriasis Treatment- China's NMPA has approved PECONDLE® (picankibart injection), the first domestically developed IL-23p19 monoclonal antibody for treating moderate-to-severe plaque psoriasis in adults.
- The Phase 3 CLEAR-1 trial demonstrated that 80.3% of patients achieved PASI 90 at week 16, significantly outperforming placebo with favorable safety profile.
- PECONDLE® offers the longest dosing interval among comparable biologics with maintenance dosing every 12 weeks, potentially improving patient compliance and quality of life.9 months agoInnovent's Picankibart NDA Accepted in China for Plaque Psoriasis Treatment- Innovent's New Drug Application (NDA) for picankibart, an anti-IL-23p19 antibody, has been accepted by China's NMPA for treating moderate to severe plaque psoriasis.
- Phase 3 trial data showed over 80% of subjects achieved PASI 90 after 16 weeks, with a convenient maintenance dosing interval of once every 12 weeks.
- The NDA acceptance is based on the CLEAR-1 study, which demonstrated significantly higher rates of skin lesion clearance and improved quality of life compared to placebo.
- Picankibart represents the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA in China.last year