LNA043 for Knee Osteoarthritis

(ONWARDS Trial)

No longer recruiting at 103 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Knee OA K-L grade 4, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LNA043, an experimental therapy, to evaluate its effectiveness for individuals with knee osteoarthritis (OA), a condition causing knee pain and stiffness. Researchers aim to determine the optimal dose by comparing different dosing schedules of LNA043 injections to a placebo, which is a harmless, inactive treatment. The trial suits those diagnosed with knee OA who have not undergone recent knee surgery. Participants should not have severe OA in the non-target knee or certain blood-related conditions. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 has shown that LNA043 is generally safe and well tolerated in people with knee osteoarthritis. One study found that LNA043 did not cause major side effects or trigger harmful immune responses, meaning it did not provoke a negative reaction from the body's defense system. Another study also reported no significant safety concerns related to the drug. Overall, the evidence suggests that LNA043 is a promising treatment with a good safety record for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Researchers are excited about LNA043 for knee osteoarthritis because it represents a novel approach to treatment. Unlike existing options like NSAIDs, corticosteroids, or physical therapy, which primarily focus on reducing inflammation and pain, LNA043 is designed to potentially regenerate cartilage. This treatment involves a direct injection to the knee, which targets the affected area more precisely. By potentially addressing cartilage loss, a root cause of osteoarthritis, LNA043 offers a promising new avenue that could lead to improved joint function and long-term relief.

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

Research has shown that LNA043 might aid in knee osteoarthritis by repairing damaged cartilage. In one study, patients who received LNA043 injections exhibited signs of cartilage repair. Earlier studies also found that LNA043 is generally safe, as it did not cause major side effects. The treatment was well-tolerated, with no serious safety issues reported. These findings suggest that LNA043 could be effective for knee osteoarthritis. Participants in this trial will receive different dosing regimens of LNA043 or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a diagnosis of primary knee OA by standard American College of Rheumatology clinical and radiographic criteria.

There may be additional requirements for participation that are outlined in the study plan.

You are between 40 and 75 years of age.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Core Treatment

Participants receive intra-articular injections of LNA043 or placebo for 2 years

104 weeks

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue treatment in a 3-year extension period

156 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LNA043

How Is the Trial Designed?

Group I: LNA043 Dosing Regimen D Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen D

Group II: LNA043 Dosing Regimen C Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen C

Group III: LNA043 Dosing Regimen B Experimental Treatment 1 Intervention

LNA04 injection to the knee with dosing regimen B

Group IV: LNA043 Dosing Regimen A Experimental Treatment 1 Intervention

LNA043 injection to the knee with dosing regimen A

Group V: Placebo Placebo Group 1 Intervention

Injection to the knee

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- ... Study Overview. The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9800282/

Angiopoietin-like 3-derivative LNA043 for cartilage ... LNA043 is safe and well tolerated in patients with knee OA. A FIH, randomized, single-center, placebo-controlled, double-blind, single ascending dose trial ( ...

3. oarsijournal.com oarsijournal.com/article/S1063-4584(21)00328-9/fulltext

First-in-human trial results of LNA043, a novel cartilage ... In this study, LNA043 displayed a favorable safety profile without any clinically significant drug-related safety signals or immunogenicity.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724506343

POS0277 ANABOLIC EFFECT OF LNA043, A NOVEL ... Treatment with 4 weekly ia injections of 20 mg LNA043 resulted in regeneration of damaged cartilage in patients with femoral articular cartilage lesions.

5. novartis.com novartis.com/news/novartis-receives-fda-fast-track-designation-lna043-osteoarthritis-knee

Novartis receives FDA fast track designation for LNA043 in ... In a proof of concept study, treatment with intra-articular injections of LNA043 resulted in regeneration of damaged cartilage in patients with ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT03275064

Study of Safety, Tolerability, Preliminary Efficacy of Intra ... The purpose of this two-part study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043 in regenerating ...