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
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
This was a multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating intra-articular LNA043 in patients with knee osteoarthritis.
The study was structured as a two-period design:
Participants were randomized in a 1:1:1:1:1 ratio into five treatment arms:
All injections were administered intra-articularly (i.a.) to the target knee. Placebo injections (saline solution) were used throughout the study to maintain blinding and ensure consistency in injection frequency across arms.
During the Extension Period:
The final year of the Extension Period was a no-treatment follow-up phase for all participants.
The study was terminated early following the Week 104 primary endpoint analysis due to lack of effect.There was no safety related reasons for early termination or safety concerns for the subjects in the study.
Key Inclusion Criteria:
Key Exclusion Criteria:
Caba, C1428AZF, Argentina
Christchurch, 8011, Australia
Waikanae Beach, 5036, Australia
Brno-Zidonice, CZE 61500, Czechia
Shinagawa, Tokyo 140 0014, Japan
Shinjuku Ku, Tokyo 160-0008, Japan
Suginami, Tokyo 166-0002, Japan
Chuoh-ku, 104-0031, Japan
Ciudad de, CP 06700, Mexico