ONWARDS
Research type
Research Study
Full title
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
IRAS ID
1003732
Contact name
Ashley Brower
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-004897-22
Clinicaltrials.gov Identifier
Research summary
Osteoarthritis is one of the most common chronic health conditions in the world and a leading cause of pain and disability amongst adults. This study will involve around 550 patients with knee osteoarthritis, in approximately 19 countries worldwide, between the ages of 40 and 75 years. In the UK, 3 centres will participate, who will collectively have about 20 patients taking part in the study. The study aims to evaluate if the investigational drug LNA043 promotes the regeneration of the cartilage tissue in the knee joint and is safe and well tolerated when administered at different doses and frequencies in patients with knee osteoarthritis. Two doses will be tested (20 mg and 40 mg), which will be administered in cycles every 6 or 12 months. Only one knee (target knee) will be chosen and will receive the study treatment, however assessments may also be conducted on the other knee. The study compares the effects of the different dosing of LNA043 with a placebo over a period of 5 years to determine the best dosing schedule of LNA043 leading to knee changes, symptom relief and improvement in function and quality of life in knee osteoarthritis patients.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0164
Date of REC Opinion
15 Jul 2021
REC opinion
Further Information Favourable Opinion