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Study on the Effects of LNA043 for Patients with Knee Osteoarthritis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying knee osteoarthritis, a common joint condition that causes pain and stiffness in the knees. The study will evaluate a treatment called LNA043, which is a powder that is mixed into a solution and injected directly into the knee joint. The purpose of the study is to assess how effective, safe, and tolerable this treatment is compared to a placebo in patients who have symptoms of knee osteoarthritis.

Participants in the study will receive either the LNA043 treatment or a placebo through injections into the knee. The study will last for up to five years, during which time the effects of the treatment on knee structure and function will be monitored. The main focus will be on changes in the knee's structure, particularly in the central part of the knee joint, over a period of two years. Additionally, the study will look at changes in pain levels, physical function, and cartilage structure, as well as any side effects that may occur.

The study aims to provide valuable information on whether LNA043 can help improve the condition of the knee joint in people with osteoarthritis, potentially offering a new treatment option for managing this painful condition. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the treatment's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, body mass index, and diagnosis of knee osteoarthritis.

    The assessment ensures that the condition is primarily affecting the knee and that pain levels meet the study's criteria.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to evaluate the current condition of the knee. This includes imaging to assess the knee structure and measuring pain levels using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

  3. Step 3

    Treatment administration

    Participants receive the study medication, LNA043, or a placebo. The medication is administered as a powder for solution for injection directly into the knee joint (intraarticular use).

    The frequency and dosage of the injections are determined by the study protocol and are administered over a specified period.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor changes in knee structure and pain levels. These assessments occur at various intervals throughout the study period.

    Participants are evaluated for any adverse events or changes in their condition.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

    This includes a comprehensive review of changes in knee structure, pain levels, and physical function.

Who can join the trial?

7 criteria

  • Men and women who are between 40 and 75 years old.
  • Have a Body Mass Index (BMI) of less than 40 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
  • Have been diagnosed with primary tibiofemoral knee osteoarthritis (OA) using standard clinical and X-ray criteria. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
  • Have knee osteoarthritis with a specific X-ray grade (K-L grade 2 or 3) and mainly affecting the inner part of the knee joint, shown by a narrowing of the joint space.
  • Experience a certain level of pain in the knee, measured by a score of 20-45 out of 50 on the WOMAC pain scale, during two assessments after stopping pain medications for a specific period.
  • Have had pain in the knee for at least 6 months.
  • The main source of pain in the body should be due to osteoarthritis in the knee, with a specific score on the Widespread Pain Index and Symptom Severity scale.

Who cannot join the trial?

8 criteria

  • Patients who have any other joint diseases besides osteoarthritis cannot participate. Osteoarthritis is a condition where the protective cartilage that cushions the ends of the bones wears down over time.
  • Patients who have had surgery on the knee that is being studied are not eligible.
  • Patients who have received certain treatments for osteoarthritis in the past 6 months cannot join the study.
  • Patients with a history of cancer in the past 5 years, except for some skin cancers, are excluded.
  • Patients who have any serious medical conditions that could affect their safety or the study results are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are participating in another clinical trial at the same time are not eligible.
  • Patients who have allergies to any of the study medications or their ingredients cannot join the study.
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Investigated drugs

LNA043 is a medication being studied for its potential to improve knee structure in patients with symptomatic knee osteoarthritis. The trial aims to assess how this medication affects the knee joint over a period of time, specifically looking at changes in the central part of the knee. The goal is to determine if LNA043 can provide relief and improve the condition of the knee compared to not receiving the active treatment.

What is already known about the treatment

LNA043 – LNA043 is administered through an injection directly into the knee joint, known as intra-articular administration. It is currently being studied in clinical trials for its potential use in treating knee osteoarthritis, a condition characterized by joint pain and stiffness. The main therapeutic indication for LNA043 is to alleviate symptoms and improve joint function in patients with osteoarthritis. At the molecular level, LNA043 is believed to work by promoting the repair and regeneration of cartilage tissue, which may help in reducing pain and improving mobility. It is classified pharmacologically as a regenerative medicine product, focusing on tissue repair and regeneration.

Investigated diseases

Osteoarthritis – Osteoarthritis is a common joint disorder that primarily affects the cartilage, which is the protective tissue at the ends of bones. Over time, the cartilage wears down, leading to pain, swelling, and reduced motion in the affected joints. It most commonly occurs in the knees, hips, and hands. As the disease progresses, the bones may begin to rub against each other, causing further pain and joint damage. This can lead to the development of bone spurs and a decrease in joint function. The progression of osteoarthritis can vary, with some individuals experiencing rapid changes while others have a slower progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509937-37-00Protocol codeCLNA043A12202Estimated enrolment581 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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