NL-OMON52598招募中2 期
A randomized, placebo-controlled, patient and investigator blinded study investigating the safety, tolerability and preliminary efficacy of 8-week treatment with intra-articular LRX712 to regenerate articular cartilage in patients with mild/moderate knee osteoarthritis - Proof of Mechanism Study of LRX712 in patients with mild/moderate knee OA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient must be between 35 and 75 years old at screening
- •- Patient must weigh at least 50 kg to participate in the study, and must have
- •a body mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI =
- •Body weight (kg) / [Height (m)]2 at screening
- •- Patient must have knee osteoarthritis (OA) at screening. Structural signs of
- •Radiographic OA need to be confirmed by radiography taken in standing
- •weight-bearing fixed flexion position and PA view, indicating Kellgren-Lawrence
- •grade 2 or 3 in the index knee
- •- Patient must have symptomatic disease predominantly in one (the index) knee,
- •with minimal or no symptoms in the contralateral knee. Symptomatic disease is
- •defined as having pain in the knee >= 4 days of the week for at least 3 months
- •at screening.
- •- Patient must have radiographic confirmation of a medial joint space width of
- •1.5 to 3.5 mm for females, or 2 to 4 mm for males, measured at the X=0.225
- •fixed point location within the medial tibio-femoral compartment of the index
- •knee, at screening.
- •- Patients must be ambulatory at screening (walk without aid)
排除标准
- •- Patient has a known autoimmune disease, inflammatory or chronic arthropathy
- •other than OA (including but not limited to rheumatoid arthritis, psoriatic
- •arthritis, ankylosing spondylitis, SLE, (systemic lupus erythematosus), CPPD
- •(calcium pyrophosphate dihydrate crystal deposition disease),, gout and
- •fibromyalgia), active acute or chronic infection of the joint, Lyme disease
- •involving the knee, systemic cartilage disorder, or a known systemic connective
- •tissue disease
- •- Subject has had surgical treatment of the target knee using mosaicplasty,
- •microfracture, or resecting more than 50% of meniscal tissue
- •- Subject has symptomatic, isolated patello-femoral pain in the index knee as
- •per the Investigator's examination
- •- Subject has malalignment (valgus- or varus-deformity) in the index knee >=
- •7.5° as per anatomic PA axis measured by weight-bearing short knee radiography.
- •- Effusion in the index knee that clinically requireding aspiration in the past
- •12 weeks prior to screening, or that is clinically relevant in the index knee
- •as per physical examination (bulge sign, patellar tap) at screening or Day 1
- •- Any local i.a. treatment to the knee, including but not restricted to
- •viscosupplementation and corticosteroids, within 12 weeks prior to screening
- •- Signs or symptoms, in the judgment of the investigator, of a clinically
- •significant systemic
- •viral, bacterial or fungal infection within 30 days prior to screening;
- •COVID-19 specific: It is highly recommended that PCR or antigen testing for
- •COVID-19 be completed within 1 week prior to first dosing. If testing is
- •performed, negative test results are required prior to enrollment into the
- •study. Additional testing may occur at the discretion of the investigating
- •physician. This requirement may be ignored if the pandemic is declared ended by
- •the country where the site is located, and resumed if the pandemic recurs.
研究者
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