Canakinumab + LNA043 for Knee Osteoarthritis

Recruiting at 21 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Knee replacement, Rheumatoid arthritis, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

23 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Canakinumab + LNA043 different from other treatments for knee osteoarthritis?

Canakinumab + LNA043 is unique because it combines two components: Canakinumab, which targets inflammation by blocking a protein called interleukin-1 (IL-1), and LNA043, which may help repair joint tissue. This dual approach aims to both reduce inflammation and promote joint healing, which is different from many existing treatments that primarily focus on pain relief. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests two treatments for knee osteoarthritis. Canakinumab reduces inflammation and pain by blocking a specific protein. LNA043 helps repair damaged cartilage in the knee. The goal is to see if these treatments are safe and effective for patients with knee osteoarthritis.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with moderate to severe knee pain from osteoarthritis, confirmed by specific clinical and imaging criteria. Participants must have had consistent pain over the last 3 months and show inflammation markers in their blood. They can't join if they've had recent knee surgery, plan a knee replacement, suffer from other inflammatory diseases or have significant misalignment in their knees.

Inclusion Criteria

My knee MRI shows I have moderate to severe inflammation.

My knee arthritis is moderate to severe, with specific joint space measurements.

High sensitivity C-reactive Protein (hsCRP) ≥2 mg/L

Exclusion Criteria

I have had a hip replacement or will have one soon.

I have had or plan to have knee surgery, including replacement or other procedures, within the past year.

I have a condition like rheumatoid arthritis or lupus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of canakinumab and/or LNA043

12 weeks

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Visits at Day 15, 29, 43, 57, 71, 85, 197, and 365

Treatment Details

Interventions

• Canakinumab
• LNA043

Trial Overview The study tests the safety and effectiveness of two drugs: Canakinumab (anti-inflammatory) and LNA043 (cartilage stimulating), injected into the knee. It will compare these treatments against a placebo to see which is better at reducing osteoarthritis symptoms.

Participant Groups

Group I: canakinumab + LNA043 Experimental Treatment 2 Interventions

canakinumab + LNA043

Group II: canakinumab Experimental Treatment 1 Intervention

canakinumab

Group III: LNA043 Experimental Treatment 2 Interventions

Placebo to canakinumab + LNA043

Group IV: Placebo Placebo Group 1 Intervention

Placebo to canakinumab

Canakinumab is already approved in European Union, United States for the following indications:

Approved in European Union as Ilaris for:

• Cryopyrin-Associated Periodic Syndromes (CAPS)
• Familial Cold Autoinflammatory Syndrome (FCAS)
• Muckle-Wells Syndrome (MWS)
• Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
• Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
• Familial Mediterranean Fever (FMF)
• Systemic Juvenile Idiopathic Arthritis (SJIA)
• Adult-Onset Still's Disease (AOSD)

Approved in United States as Ilaris for:

• Cryopyrin-Associated Periodic Syndromes (CAPS)
• Familial Cold Autoinflammatory Syndrome (FCAS)
• Muckle-Wells Syndrome (MWS)
• Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
• Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
• Familial Mediterranean Fever (FMF)
• Systemic Juvenile Idiopathic Arthritis (SJIA)
• Adult-Onset Still's Disease (AOSD)

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

References

1. United States pubmed.ncbi.nlm.nih.gov

Intraarticular injection of anakinra in osteoarthritis of the knee: a multicenter, randomized, double-blind, placebo-controlled study. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

An open-label study of a second course of hylan G-F 20 for the treatment of pain associated with knee osteoarthritis. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Phase II Trial of Lutikizumab, an Anti-Interleukin-1α/β Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. [2020]