A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
TerminatedPhase 2Results postedLast updated 24 October 2025
What this trial tests
Phase 2 trial testing canakinumab in Knee Osteoarthritis in 23 participants. Terminated before completion.
Adults 40 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cartilage Volume in the Index Region Measured by MRI at Day 197 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)Primary· Baseline, Day 197
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
108.33
± 226.451
Placebo to ACZ885
-26.13
± 65.204
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale (ACZ885 Versus Placebo to ACZ885)Primary· Baseline, Day 85
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Group
Value
95% CI
ACZ885 600 mg
22.2
± 20.09
Placebo to ACZ885
13.9
± 13.89
Number of Participants With Anti-LNA043 Antibodies (Placebo to ACZ885+LNA043 Versus ACZ885 + LNA043)Secondary· From pre-dose up to Day 365
To evaluate the immunogenicity of LNA043 via validated ligand-binding assay of potential anti-LNA043 antibodies.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
0
ACZ885 600 mg + LNA043 40 mg
0
Maximum Serum Concentration (Cmax) of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)Secondary· Pre-dose Day 1, Day 15, Day 43 and 60 minutes after first injection of LNA043 on Day 15
ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.
Cmax is defined as the maximum (peak) observed concentration following a dose. ANGPTL3 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). ANGPTL3 was determined by a validated ligand binding assay; the anticipated LLOQ is 39.7 pmol/L in serum.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
16.2
± 2.47
ACZ885 600 mg + LNA043 40 mg
24.1
± 7.32
Synovial Fluid Concentrations of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)Secondary· Pre-dose on Days 1, 15, 43, and 71
ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.
ANGPTL3 was measured in synovial fluid.
Day 1
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
NA
± NA
ACZ885 600 mg + LNA043 40 mg
NA
± NA
Day 15
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
NA
± NA
ACZ885 600 mg + LNA043 40 mg
NA
± NA
Day 43
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
NA
± NA
ACZ885 600 mg + LNA043 40 mg
NA
± NA
Day 71
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
NA
± NA
ACZ885 600 mg + LNA043 40 mg
NA
± NA
Maximum Serum Concentration (Cmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)Secondary· Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15
Cmax is defined as the maximum (peak) observed concentration following a dose. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
120
ACZ885 600 mg + LNA043 40 mg
149
Time to Reach Maximum Serum Concentration (Tmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)Secondary· Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
2
ACZ885 600 mg + LNA043 40 mg
4.02
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)Secondary· Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15
AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LNA043. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
800
ACZ885 600 mg + LNA043 40 mg
1880
Change in Cartilage Volume of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)Secondary· Baseline, Day 197 and Day 365
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Day 197
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
108.33
± 226.451
ACZ885 600 mg + LNA043 40 mg
307.90
± 580.213
ACZ885 600 mg
-82.33
± 390.645
Day 365
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
152.78
± 135.128
ACZ885 600 mg + LNA043 40 mg
20.54
± 557.708
ACZ885 600 mg
-129.93
± 544.793
Change in Cartilage Volume of the Index Region Measured by MRI at Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)Secondary· Baseline, Day 365
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
152.78
± 135.128
Placebo to ACZ885
20.54
± 557.708
Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)Secondary· Baseline, Day 197 and 365
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Day 197
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
0.07
± 0.083
ACZ885 600 mg + LNA043 40 mg
0.13
± 0.212
ACZ885 600 mg
-0.02
± 0.121
Day 365
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
-0.03
± 0.046
ACZ885 600 mg + LNA043 40 mg
0.04
± 0.168
ACZ885 600 mg
-0.05
± 0.152
Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)Secondary· Baseline, Day 197 and 365
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Day 197
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
0.07
± 0.083
Placebo to ACZ885
0.06
± 0.112
Day 365
Group
Value
95% CI
Placebo to ACZ885+LNA043 40 mg
-0.03
± 0.046
Placebo to ACZ885
0.11
± 0.072
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 52 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 24 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04814368.