EUCTR2016-004052-30-CZ进行中（未招募）1 期
A two part randomized, placebo-controlled, patient and investigator blinded, Proof of Concept study investigating the safety, tolerability and preliminary efficacy of multiple intra-articular LNA043 injections in regenerating the articular cartilage of the knee in patients with articular cartilage lesions (Part A) and in patients with knee osteoarthritis (Part B).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient is =18 and =55 years old at time of screening.
- •- Patient has a body mass index (BMI) <30 kg/m2 at screening. For patients with a BMI >30 but = 33 kg/m2, eligibility will be decided by consultation with the sponsor.
- •- Patient has a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either the femoral condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed within 9 months before screening visit and confirmed by screening 3T MRI.
- •- Patient has an onset of pain and impairment of function between two (2) months and two (2) years before screening.
- •- Patient reports a KOOS (sports and recreational activities subscale) score of 60 or less at both screening and Day 1.
- •Inclusion Criteria Part B
- •- Patient is =18 and =75 years old at time of screening.
- •- Patient has a body mass index (BMI) =35 kg/m2 at screening
- •- Diagnosis of femorotibial osteoarthritis(OA) in the target knee by standard American
- •College of Rheumatology (ACR) criteria at study start (clinical AND
- •radiographic criteria)
- •- Patient has a Kellgren & Lawrence (K&L) grade 2 or 3 OA of the knee with Joint Space Width (JSW) 2-4 mm
- •evaluated with X-Ray at screening.
- •- 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 more
- •than 50% of the days during the last 3 months from screening.
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Exclusion criteria Part A & B
- •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 15 days after stopping of investigational drug.
- •- Patient has had surgical treatment of the target knee using
- •mosaicplasty, microfracture, meniscectomy >50% (Note: prior
- •diagnostic arthroscopy with debridement and lavage, <50%
- •meniscectomy, lateral release, patellar realignment, medial
- •patellofemoral ligament reconstruction are acceptable if performed at least 2 months prior to screening; anteriorcruciate ligament
- •reconstrucion is acceptable if performed 12 months prior to screening, or less if restoration of joint function is evident, and agreed by the sponsor).
- •- Patient has an unstable target knee joint or insufficiently reconstructed ligaments based on medical history and physical examination by the investigator.
- •Prohibited medication updated with reference to dosing (formerly
- •screening).
- •Exclusion Criteria Part A only
- •- Regular smokers (> 5 cigarettes/day). Urine cotinine levels will be
- •measured during screening for all patients. Regular smokers will be
- •defined as any patient who reports tobacco use of > 5 cigarettes/day
- •and/or who has a urine cotinine = 500 ng/mL.
- •- Patient has radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade =2 based on X-ray evaluation performed within 9 months from screening.
- •- Patient has patellofemoral dysplasia Dejour Grade B-D based on X-ray evaluation performed within 9 months from screening.
- •- Patient has malalignment (valgus- or varus-deformity) in the target
- •knee = 5° based on X-ray evaluation performed within 9 months from screening. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA) projection.
- •Exclusion Criteria Part B only
- •- Regular smokers (> 10 cigarettes/day).
- •- Clinical signs of inflammation (i.e., redness) in the target knee.
- •- History of knee replacement (unilateral or total) in either knee.
- •- Presence of severe hip OA conditioning lower limb function according to PI's evaluation.
- •- Nephrotic syndrome and/or significant proteinuria
- •- History of coagulopathy or medical condition requiring anticoagulation which would preclude knee injection
- •- Patient has malalignment (valgus- or varus-deformity) in the target
- •knee = 7.5° based on X-ray evaluation. In suspected cases, the
- •mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA)
- •projection.
- •Other protocol defined exclusion criteria's may apply
研究者
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