NCT07831577尚未招募2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2/3, Study to Evaluate the Efficacy and Safety of an Intraarticular Injection of GNSC-001 in Participants With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Change from baseline in OA pain as assessed by the Weekly Average of Daily Pain (WADP) Numeric Rating Scale (NRS) at Week 52
研究概览
简要总结
The goal of this clinical trial is to learn if GNSC-001 works to treat knee osteoarthritis in adults. It will also learn about the safety of GNSC-001. The main questions it aims to answer are:
- Does GNSC-001 lower daily knee joint pain and improve function in participants?
- What medical problems do participants have when taking GNSC-001?
Researchers will compare GNSC-001 to a placebo (a look-alike substance that contains no drug) to see if GNSC-001 works to treat knee osteoarthritis.
Participants will:
- Receive a single injection of immune-modulation, and GNSC-001 or a placebo, in their knee
- Take an oral immune-modulating pill every day for the first 22 days
- Visit the clinic at least 9 times over 2 years for checkups and tests
- Keep a diary of their symptoms and the number of times they use a rescue medication
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA in the target knee confirmed by radiograph and with a Kellgren-Lawrence (KL) score of 2 or 3
- •OA symptoms affecting the target knee present for at least 6 months
- •NRS pain score 5-9 (0-10 scale) in the target knee within the 24 hours prior to the time of consent
- •Synovitis and/or effusion detectable on imaging
- •Willing to stop use of any medication taken for knee OA pain for the duration of the study, including but not limited to nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Able to provide written informed consent and comply with the requirements of the study
排除标准
- •Body mass index (BMI) > 38 kg/m2
- •NRS pain score in other (non-target) knee ≥ 4
- •Large effusion, substantial malalignment, structural compromise, prior partial or total joint replacement of target knee
- •Surgery on the target knee within the 6 months prior to screening or the anticipated need for treatment of either knee prior to the Month 12 Visit.
- •Current or history of inflammatory conditions (e.g., gout or rheumatoid arthritis), other joint disorders, septic arthritis, nerve damage or injury, chronic pain not associated with knee OA (e.g., fibromyalgia, hip OA), or otherwise immunocompromised
- •Active infection
- •Uncontrolled diabetes mellitus, glycosylated hemoglobin (HbA1c) >7.0% at screening
- •Initiation of GLP-1RA, or similar medication, within the last 12 months, or discontinued within last 6 months prior to Screening
- •Use of opioid medications (including tramadol or tapentadol) or medical/recreational cannabinoids (oral/inhaled) for > 5 days within the last 30 days
- •Use of medications for the treatment of chronic pain, immunosuppressant medications, or intra-articular injections into the target knee within 90 days of Day 1
- •Current use of anticoagulant therapy
- •Received live vaccine within 6 weeks of Day 1
- •Participation in another interventional clinical study with experimental therapy within 90 days prior to screening
- •Relies on a walking aids (e.g., cane, crutch, walker, wheelchair) or a personal assistant
- •Pregnant, breastfeeding, or intending to become pregnant during the study
研究组 & 干预措施
GNSC-001
Experimental
干预措施: Gene Therapy GNSC-001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in OA pain as assessed by the Weekly Average of Daily Pain (WADP) Numeric Rating Scale (NRS) at Week 52
时间窗: Baseline and Week 52
Change from baseline in the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 52
时间窗: Baseline and Week 52
Incidence and severity of treatment emergent adverse events (TEAEs), events of clinical interest (ECIs), and serious adverse events (SAEs)
时间窗: From enrollment to the end of study at 104 weeks
次要结局
未报告次要终点
研究者
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