A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.
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
- •Age 18-75 years
- •Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- •Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
- •Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
- •Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
- •Stable doses of protocol permitted background therapy (if any)
排除标准
- •Other inflammatory conditions that may affect the evaluation of the study drug
- •Prior treatment with >2 biologic agents
- •Recent use of prohibited medications (specific washout periods apply)
- •Non-plaque psoriasis forms or drug-induced psoriasis
- •Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
- •Significant laboratory abnormalities
- •Pregnancy or breastfeeding
研究组 & 干预措施
Picankibart Group 2
Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2.
干预措施: Placebo (Other)
Picankibart Group 2
Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2.
干预措施: Picankibart (Drug)
Placebo Group
Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26.
干预措施: Placebo (Other)
Placebo Group
Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26.
干预措施: Picankibart (Drug)
Picankibart Group 1
Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1.
干预措施: Picankibart (Drug)
结局指标
主要结局
Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response
时间窗: Week 26
The ACR20 response is defined as ≥20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥20% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm= very well to 100 mm= very poor\]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), \[0 = no arthritis to 100 = extremely active arthritis\], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
次要结局
- Change from baseline in Disease Activity Score in 28 Joints (DAS28)-CRP score(Week 26, and from baseline to Week 56)
- Percentage of participants who achieved an ACR50 response(Week 26, and from baseline to Week 56)
- Percentage of participants who achieved an ACR70 response(Week 26, and from baseline to Week 56)
- Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Week 26, and from baseline to Week 56)
- Change from baseline in Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) score(Week 26, and from baseline to Week 56)
- Enthesitis/dactylitis resolution rates(Week 26, and from baseline to Week 56)
- Percentage of participants who achieved 75%Psoriasis Area and Severity Index 75 response(From baseline to Week 56)
- Change from baseline in van der Heijde-modified Total Sharp Score (vdH-mTSS)(Week 26 and Week 56)
- Percentage of participants who experienced adverse events (AEs)(From baseline to Week 56)
- Percentage of participants who experienced serious adverse events (SAEs)(From baseline to Week 56)
- Maximum plasma concentration (Cmax) of picankibart(From baseline to Week 56)
- Area under the concentration-time curve (AUC) of picankibart(From baseline to Week 56)
- Percentage of participants who developed anti-drug antibody (ADA)(From baseline to Week 56)
- Percentage of participants who developed neutralizing antibody (NAb)(From baseline to Week 56)