TerminatedPhase 2

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

Stopped: Study early terminated due to lack of effect (did not meet primary/ secondary endpoints). This decision was not linked to safety concerns

United States576 participantsStarted 2021-05-31

Plain-language summary

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

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Males and females between 40 and 75 years of age * Body mass index (BMI) \< 40 kg/m2 * Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria Key Exclusion Criteria: * Participants with radiographic knee OA K-L grade = 4 on the non-target knee * Arthroscopy of the target knee within the 6 months prior to Screening * Hemoglobin \< 8.5 g/dL (85 g/L) or platelet count \< 100,000/μL

What they're measuring

Change From Baseline in Cartilage Thickness in the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee at Week 104

Timeframe: Baseline, Week 104

Trial details

NCT IDNCT04864392

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-29

Results submitted2026-02-13

View on ClinicalTrials.gov More Osteoarthritis trials