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)

Yamada Hiroyuki0 个研究点目标入组 40 人开始时间: 2021年6月23日最近更新: 2023年10月17日

研究概览

暂无简介。

•1. Body mass index (BMI) < 40 kg/m2 at Screening Visit 1
•2. Diagnosis of primary tibiofemoral knee OA in the target knee by standard American College of Rheumatology (ACR) clinical and radiographic criteria at Screening Visits
•3. 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 at Screening Visit 1
•4. Symptomatic OA with pain in the target knee for at least 6 months prior to Screening Visit 1
•5. Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index (WPI) score of =<6 and a Symptom Severity score (SS score) of <7 at Screening Visit 2

•1. Radiographic knee OA K-L = 4 on the non-target knee at Screening Visit 1
•2. WOMAC Pain > 15 (out of 50) in the non-target knee at Screening Visit 2
•3. Severe malalignment (>7.5 degree varus or valgus) in the anatomical axis of the target knee, measured using X-ray at Screening Visit 1
•4. Arthroscopy of the target knee within the 6 months prior to Screening Visit 1 or planned during the study
•5. Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy; partial or complete joint replacement for either knee; planned knee surgery for either knee during the study
•6. Inability to undergo MRI (e.g., claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g., non MRI-compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator)

发起方

Yamada Hiroyuki