A randomized, four-arm, canakinumab placebo-controlled, participant, investigator and sponsor-blinded study investigating the safety, tolerability and efficacy of intra-articular canakinumab followed by intra-articular LNA043 in patients with knee osteoarthritis

ovartis Pharma AG0 个研究点目标入组 138 人开始时间: 2022年6月10日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•- Moderate to severe OA pain (corresponding to NRS Pain =5 to =9) in the target knee for the majority of days in the last 3 months prior to Screening
•- KOOS pain subscale <60 for the target knee during Screening
•- High sensitivity C-reactive Protein (hsCRP) =1.8 mg/L
•- Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
•- Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score =13)
•- 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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 98

•- History of, or planned; knee replacement(partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy
•- Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
•- Malalignment >7.5° in the target knee (either varus or valgus)
•- Any diagnosis of systemic inflammatory arthritis or connective tissue disease including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
•- lpsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period
•- other protocol-defined exclusion criteria may apply

发起方