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

NCT04864392 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2026-04-02

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2024-09-29
Completion
2025-05-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • China
  • Czechia
  • Denmark
  • Estonia
  • India
  • Japan
  • Mexico
  • Poland
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864392 on ClinicalTrials.gov