2024-518916-38-00招募中2 期
A multicenter, randomized, double-blind, placebo-controlled, proof of concept trial to investigate the efficacy and safety of intra-articular 4P004 in subjects with knee synovitis and osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 16
- 主要终点
- Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore
研究概览
简要总结
To assess the efficacy of 4P004 on OA pain in the target knee (TK) at Week (W) 4
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Monitor, Subject, Analyst, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female participants can take part in this study if they: • are aged between 40 and 80 years,
- •weigh over 40 kilograms (kg),
- •have a body mass index (BMI, the ratio of height to bodyweight) between 18.5 and 35,
- •are able to walk unaided, or with the assistance of a cane,
- •have had OA pain in the knee to be treated for at least 6 months before taking part,
- •have synovitis of the knee to be treated, assessed by magnetic resonance imaging (MRI), and
- •meet certain requirements related to their OA/synovitis diagnosis and pain levels.
- •Please see protocol for a detailed list of inclusion criteria.
排除标准
- •Pregnant or breastfeeding women.
- •Treatment with systemic corticosteroids (other than IA) at a dose greater than 10 mg prednisone or the equivalent per day for more than 7 days within 4 weeks prior to the screening visit.
- •Please see protocol for a detailed list of exclusion criteria.
- •Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.
- •Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.
- •Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.
- •Any partial knee replacement of the TK.
- •Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.
- •Major knee surgery performed within the previous 12 months or planned during the trial.
- •Arthroscopy of the TK within 6 months prior to the screening visit.
- •Presence of any painful conditions that could confound accurate assessment of pain from OA in the TK, such as fibromyalgia, peripheral neuropathy or vascular insufficiency.
结局指标
主要结局
Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore
Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore
次要结局
- Change from Baseline at W2, W6, W8, W10 and W12: - Weekly average of TK daily pain (WOMAC Pain)
- Change from Baseline at W2, W4, W8 and W12: - NRS (0-10) pain in a nominated pain aggravating activity - WOMAC subscores and total score - Patient Global Assessment of OA (PGA-OA)
- % of OMERACT-OARSI Responders at W2, W4, W8 and W12
- Incidence and severity of TEAEs during the trial
- Absolute values and changes from Baseline in: - Clinical laboratory assessments (hematology, chemistry, and urinalysis) - Vital signs (systolic and diastolic blood pressure [BP], pulse rate,)
- Directed physical examination
研究者
Francis Berenbaum
Scientific
4moving Biotech
研究点 (16)
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