NCT04864392

Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With 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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 576 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, randomized, double-blind, placebo-controlled Phase IIb study evaluating intra-articular LNA043 in patients with knee osteoarthritis.

Detailed description

The study was structured as a two-period design: * A 2-year Core Period, followed by * A 3-year Extension Period, consisting of 2 years of continued treatment and 1 year of follow-up, totaling 5 years. Participants were randomized in a 1:1:1:1:1 ratio into five treatment arms: * LNA043 20 mg Q4w ×3, repeated every 6 months. * LNA043 40 mg ×1 and placebo Q4w ×2, repeated every 6 months. * LNA043 40 mg Q4w ×3 followed six months later by placebo Q4w ×3, repeated every 12 months. * LNA043 40 mg Q4w ×3, repeated every 6 months. * Placebo Q4w ×3, repeated every 6 months. 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: * Participants from the 6-month cycle arms continued with a single injection of the same LNA043 dose every 6 months. * Participants from the 12-month cycle arm received LNA043 40 mg every 12 months and placebo every other 6 months. * Participants who received placebo during the Core Period continued with a single injection of the same placebo every 6 months. 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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	LNA043	LNA043 was administered intra-articularly in various dosing regimens across four active treatment arms: * Arm 1: LNA043 40 mg Q4W ×3, repeated every 6 months * Arm 2: LNA043 40 mg Q4W ×3, followed six months later by placebo Q4W ×3, repeated every 12 months * Arm 3: LNA043 20 mg Q4W ×3, repeated every 6 months * Arm 4: LNA043 40 mg ×1, repeated every 6 months During the Extension Period, participants continued with either single injections every 6 or 12 months, based on their Core Period assignment.
DRUG	Placebo	Placebo (saline solution for injection) was administered intra-articularly in various regimens to maintain blinding and ensure consistency in injection frequency across all arms: * Arm 2: Placebo Q4W ×3 administered six months after LNA043 Q4W ×3 * Arm 4: Two placebo injections following LNA043 40 mg ×1 to complete the 3-injection cycle every 6 months * Placebo Arm: Placebo Q4W ×3 every 6 months throughout the Core and Extension Periods. In the Extension Period, placebo injections were used to match the frequency of active arms.

Timeline

• Start date: 2021-05-31
• Primary completion: 2024-09-29
• Completion: 2025-05-29
• First posted: 2021-04-28
• Last updated: 2026-04-02
• Results posted: 2026-03-30

Locations

75 sites across 15 countries: United States, Argentina, Australia, Canada, China, Czechia, Denmark, Estonia, India, Japan, Mexico, Poland, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study