Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving ACR20 at Week 12 of treatment.
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with active psoriatic arthritis. A total of 222 subjects are planned to be included.
详细描述
The study is divided into three groups, each will include 74 subjects. The primary difference among the three groups lay in the dosage and whether they were placebo groups or not. In other aspects, such as population selection, randomization, blinding and outcome evaluation (safety and efficacy), are consistent among the three groups.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol;
- •Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF;
- •Have had an psoriatic arthritis of ≥ 3 months in duration prior to signing of ICF;
- •Have had active arthritis, characterized by at least ≥3 tender joints (68 joint tenderness counts) and ≥3 swollen joints (66 joint swelling counts).
排除标准
- •History of infection as defined in the protocol;
- •Any of the medical diseases or disorders listed in the protocol;
- •Significant, uncontrolled or unstable disease in any organ.
研究组 & 干预措施
D-2570 (experimental arm 1)
Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
干预措施: D-2570 (Drug)
placebo
Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks. Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
干预措施: Placebo (Drug)
D-2570 (experimental arm 2)
Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks. Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
干预措施: D-2570 (Drug)
placebo
Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks. Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.
干预措施: D-2570 (Drug)
结局指标
主要结局
Proportion of subjects achieving ACR20 at Week 12 of treatment.
时间窗: Week 12
Definition of ACR20：The number of tender joints and swollen joints both decreased by at least 20% compared with the baseline.
次要结局
- Proportion of subjects achieving minimal disease activity at Week 12 of treatment;(Week 12)
- Proportion of subjects achieving very low disease activity at Week 12 of treatment;(Week 12)
- Plasma concentrations of D-2570(0-week 24)
- safety（AEs）(0-week 24)