Canakinumab + LNA043 for Knee Osteoarthritis

No longer recruiting at 25 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, canakinumab (an anti-inflammatory drug) and LNA043 (an experimental treatment), to evaluate their safety and effectiveness for people with knee osteoarthritis (OA). Participants will receive either one or both treatments or a placebo (a harmless pill or injection with no active drug). The trial aims to determine if these treatments can reduce knee pain and improve knee function. It may suit individuals who have experienced moderate to severe knee pain due to OA on most days over the past three months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that canakinumab is generally well-tolerated by most patients. Clinical trials have reported no serious side effects, providing some confidence about its safety for potential trial participants.

Early human trials for LNA043 indicate a good safety record, with no major safety issues or immune reactions related to the drug. This suggests that LNA043 is safe for many patients.

Both treatments appear safe based on past research. However, since this trial is still in an early stage, more information is needed to fully confirm their safety for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about canakinumab and LNA043 for knee osteoarthritis because they offer a novel approach compared to typical treatments like NSAIDs, corticosteroids, or physical therapy. Canakinumab is an anti-inflammatory drug that targets interleukin-1β, a cytokine involved in inflammation, potentially reducing pain and swelling at its source. LNA043, on the other hand, is designed to promote cartilage repair and regeneration, addressing the degenerative aspect of osteoarthritis directly. Unlike standard treatments that mainly focus on symptom relief, these therapies aim to modify the disease process itself, offering hope for more effective and lasting relief.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that canakinumab can reduce joint swelling and damage in knee osteoarthritis (OA) by blocking a protein called interleukin-1β. Studies have found that patients using canakinumab are less likely to need joint replacement surgery. Early research suggests that LNA043 can help repair damaged cartilage, offering hope for fixing knee joints in OA patients. Both treatments have undergone trials and have been found safe, with no major side effects reported. In this trial, some participants will receive a combination of canakinumab and LNA043, aiming to reduce swelling and heal cartilage, addressing key issues in knee OA. Other participants will receive either canakinumab alone, LNA043 with a placebo, or a placebo alone. ^{1 2 6 7 8}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: canakinumab + LNA043 Experimental Treatment 2 Interventions

Canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71

Group II: canakinumab Experimental Treatment 1 Intervention

Canakinumab on Day 1

Group III: Placebo+LNA043 Experimental Treatment 2 Interventions

Placebo to canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71

Group IV: Placebo Placebo Group 1 Intervention

Placebo to canakinumab on Day 1

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04814368

NCT04814368 | A Safety and Efficacy Study of Anti- ... The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA). Detailed Description. This was a non- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2828573/

Canakinumab - PMC - PubMed Central Study results demonstrated that canakinumab is able to fully suppress IL-1β-mediated joint inflammation and cartilage destruction in these models.

3. acrabstracts.org acrabstracts.org/abstract/intra-articular-canakinumab-anti-interleukin-1%CE%B2-for-treatment-of-symptomatic-knee-osteoarthritis-a-randomized-double-blind-placebo-and-naproxen-controlled-phase-ii-study/

Intra-articular Canakinumab (anti-interleukin-1β) for ... This phase II study investigated the efficacy, safety, and pharmacokinetics of canakinumab, an anti-interleukin-1β antibody, in patients (pts) with knee OA.

4. creakyjoints.org creakyjoints.org/about-arthritis/osteoarthritis/oa-treatment/canakinumab-ilaris-treatment-for-osteoarthritis/

Study Finds an IL-1 Inhibitor Biologic Stops Osteoarthritis ... Osteoarthritis patients taking canakinumab (Ilaris) in the study were less likely to need joint replacement surgery, which suggests the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10804980/

A Promising Treatment for Osteoarthritis? - PMC The reduction in joint replacements among patients who received canakinumab versus the placebo group became apparent after only 1 year of ...

6. ilarishcp.com ilarishcp.com/stills-disease/efficacy-safety/efficacy

Efficacy in Still's Disease | ILARIS® (canakinumab) HCP Within 15 days and up to 8 months, ILARIS reduced the number of active arthritic joints · Trial 1: Placebo, 7.0; ILARIS, 10.0 · Trial 2: ILARIS, 10.0 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf

ILARIS® (canakinumab) injection, for subcutaneous use The safety profile of ILARIS in AOSD patients in a randomized, double-blind, placebo-controlled study (GDE01T) in 36 adult patients (aged 22 to 70 years) was ...

8. ema.europa.eu ema.europa.eu/en/documents/product-information/ilaris-epar-product-information_en.pdf

Ilaris, INN-canakinumab - European Medicines Agency The safety profile of canakinumab in AOSD patients in a randomised, double blind placebo-controlled study (GDE01T) in 36 adult patients (aged. 22 to 70 years) ...