A 5-year, randomized, double blind, placebo-controlled, multi-center study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS) - ONWARDS

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

研究概览

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•Body mass index (BMI) < 40 kg/m2
•Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
•Radiographic disease K-L grade 2 or 3 knee OA with a predominantly medial TFC involvement defined as medial Joint Space Narrowing (medJSN) 1-2 and medJSN > lateral Joint Space Narrowing (latJSN) in the target knee
•Participants with double baseline WOMAC Pain of 20-45 (out of 50) for the target knee after discontinuation of analgesics, anti-inflammatories and or low potency opioids within 48 hours or an equivalent of 5Ã?â??T1/2 wash out period (whichever is longer)
•Symptomatic OA with pain in the target knee for at least 6 months
•Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index score of Ã¢â?°Â¤6 and a Symptom Severity score of <7

•Participants with radiographic knee OA K-L grade 4 on the non-target knee
•Participants with WOMAC Pain > 15 (out of 50) in the non-target knee
•Severe malalignment ( >7.5Ã?Â° varus or valgus) in the anatomical axis of the target knee
•Clinical signs of moderate-severe inflammation (i.e., redness, warmth, effusion) of the target knee or requiring aspiration in the target knee within 12 weeks prior to Screening
•Arthroscopy of the target knee within the 6 months prior to Screening
•Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy, partial or complete joint replacement or planned knee surgery for either knee during the study
•Unstable target knee joint (including, but not limited to, posttraumatic or congenital laxity) or insufficiently reconstructed ligaments based on medical history and/or physical examination by the Investigator
•Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute in less than 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors, and/or patellofemoral dysplasia based on clinical assessment, X-ray or MRI
•Symptomatic hip OA on either hip or hip prosthesis recently implanted (within 1 year) or foreseen within the study period (either hip)
•1Other pain conditions that could confound assessments of the pain associated with knee OA

发起方

ovartis Healthcare Pvt Ltd