NCT07511647招募中3 期
A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase 3 Clinical Study to Compare the Efficacy and Safety of QL2106 Injection to Tremfya® in Patients 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
- 招募中
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving PASI-75 at week 16.
研究概览
简要总结
It is a multicenter randomized, double-blinded, parallel, positive-controlled, Phase 3 comparative study to evaluate the efficacy and safety of QL2106 injection to Tremfya® in Patients with Moderate to Severe Plaque Psoriasis. A total of 318 subjects are planned to be included and randomized at a ratio of 1:1 to receive QL2106 injection orTremfya®
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of plaque psoriasis, with or without psoriatic arthritis (PsA), prior to the first administration of study intervention
- •Total body surface area (BSA) greater than or equal to (>=)10 percent (%) at screening and baseline
- •Total psoriasis area and severity index (PASI) >=12 at screening and baseline
- •Total investigator global assessment (IGA) >=3 at screening and baseline
- •Candidate for phototherapy or systemic treatment for plaque psoriasis
排除标准
- •Nonplaque form of psoriasis (for example [e.g.], erythrodermic, guttate, or pustular)
- •Current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
研究组 & 干预措施
QL2106 injection
Experimental
干预措施: QL2106 injection (Drug)
Tremfya®
Active Comparator
干预措施: Tremfya® (Drug)
结局指标
主要结局
Proportion of patients achieving PASI-75 at week 16.
时间窗: week 16
PASI-75
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A Phase III Study of GS101 Injection to Dupixent®NCT07386743Jiangsu Genscend Biopharmaceutical Co., Ltd572
尚未招募
3 期
A clinical trial to study the effects of Brexpiprazole in comparison to Aripiprazole in patients suffering from Acute SchizophreniaCTRI/2024/06/069258Torrent Pharmaceuticals Ltd.304
已完成
3 期
Phase 3 Clinical Trial to Compare the Efficacy, Safety, and Tolerability of a Fixed Dose Combination of Telmisartan, Amlodipine, and Bisoprolol with Separate Administration of Telmisartan, Amlodipine, and Bisoprolol in Patients with Uncontrolled Hypertension and Stable Coronary Artery DiseaseCTRI/2025/02/080101Ravenbhel Healthcare Pvt. Ltd.306
尚未招募
3 期
A Study to assess Change in HbA1C levels and blood glucose levels and safety of Alkems Semaglutide Tablet compared to Rybelsus (Novo-nordisk semaglutide Tablet) in Type 2 Diabetes Mellitus after 24 weeksCTRI/2025/10/096183Alkem Laboratories Limited232
已完成
3 期
Evaluation of Efficacy, Safety and Immunogenicity of Semaglutide injection in Weight ManagementCTRI/2025/04/085487Sun Pharmaceutical Industries Limited (SPIL)267