NCT07351968招募中1 期
A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年3月10日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
研究概览
简要总结
Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form before starting the activities related to the trial;
- •The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
- •Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ;
- •Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product.
排除标准
- •History of other diseases that may involve the target joint;
- •History of major trauma or surgery of knee joint and hip joint in the past year;
- •Plan to undergo surgical procedure during the study;
- •Most or complete loss of mobility;
- •There are other diseases that may confuse the assessment of osteoarthritis pain;
- •There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
- •There are serious or poorly controlled concomitant diseases;
- •Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
- •Those who require drug treatment or surgical intervention;
- •History of malignant tumors within 5 years before screening;
- •Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
研究组 & 干预措施
HRS-2129 Low Dose Group
Experimental
HRS-2129 low dose group.
干预措施: HRS-2129 Tablet Placebo (Drug)
Celecoxib Group
Active Comparator
Celecoxib group.
干预措施: Celecoxib capsule (Drug)
Celecoxib Group
Active Comparator
Celecoxib group.
干预措施: HRS-2129 Tablet Placebo (Drug)
Placebo Group
Placebo Comparator
Placebo group.
干预措施: Celecoxib Capsule Placebo (Drug)
Placebo Group
Placebo Comparator
Placebo group.
干预措施: HRS-2129 Tablet Placebo (Drug)
HRS-2129 Low Dose Group
Experimental
HRS-2129 low dose group.
干预措施: Celecoxib Capsule Placebo (Drug)
HRS-2129 High Dose Group
Experimental
HRS-2129 high dose group.
干预措施: HRS-2129 Tablet (Drug)
HRS-2129 High Dose Group
Experimental
HRS-2129 high dose group.
干预措施: Celecoxib Capsule Placebo (Drug)
HRS-2129 High Dose Group
Experimental
HRS-2129 high dose group.
干预措施: HRS-2129 Tablet Placebo (Drug)
HRS-2129 Low Dose Group
Experimental
HRS-2129 low dose group.
干预措施: HRS-2129 Tablet (Drug)
结局指标
主要结局
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
时间窗: At week 4.
次要结局
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.(From baseline to Week 1, 2 and 3.)
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.(From baseline to Week 1, 2, 3 and 4.)
- Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).(From baseline to Week 1, 2, 3 and 4.)
- Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking).(From baseline to Week 1, 2, 3 and 4.)
- Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.(From baseline to Week 1, 2, 3 and 4.)
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.(From baseline to Week 1, 2, 3 and 4.)
- Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.(From baseline to Week 1, 2, 3 and 4.)
- Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.(At Week 1, 2, 3 and 4.)
- Adverse events (AEs) occurred during the study.(During the study, approximately 8 months.)
- Serious adverse events (SAEs) occurred during the study.(During the study, approximately 8 months.)
研究者
研究点 (1)
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