Phase 2 Osteoarthritis Trial, Terminated NCT04864392 Sponsor: Novartis Pharmaceuticals Condition: Osteoarthritis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04864392) enrolled 576 participants across five groups, all of whom had knee osteoarthritis. Four groups received different doses or schedules of an investigational injection called LNA043, and one group received a placebo (an inactive injection). The trial was primarily measuring whether LNA043 affected the thickness of cartilage — the cushioning tissue inside the knee joint — over about two years (104 weeks). It also measured participants' self-reported knee pain and physical function using a standard questionnaire called WOMAC, where lower scores indicate less pain and better function. The reported data shows that for the primary outcome — change in cartilage thickness in a specific part of the knee joint — all five groups showed a small reduction in cartilage thickness over the two years. The four LNA043 groups showed reductions ranging from approximately −0.257 mm to −0.303 mm, while the placebo group showed a reduction of approximately −0.267 mm. For the secondary outcomes measuring pain and physical function using the WOMAC questionnaire (scored 0–100, where lower is better), all groups also reported reductions in their scores at two years. Pain scores fell by between approximately 27.8 and 32.5 points in the LNA043 groups, compared with approximately 30.0 points in the placebo group. Similar patterns were reported for the function scale and other cartilage thickness measurements across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Osteoarthritis Trial, Terminated

NCT04864392
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 40 and 75 years old (male or female)
  • Your body weight falls within a certain range — specifically, your BMI (a measure of body weight relative to height) is below 40
  • You have been diagnosed with knee osteoarthritis (wear-and-tear of the knee joint) in the main knee joint, confirmed by standard medical and X-ray criteria

Who may not be able to join:

  • The knee that is not being treated in this trial has the most severe level of osteoarthritis as seen on X-ray (the highest grade, known as grade 4)
  • You have had a keyhole surgery procedure on the knee being treated in this trial within the last 6 months
  • Your blood test shows that you have low levels of haemoglobin (a protein in red blood cells that carries oxygen) or a low platelet count (platelets help your blood to clot) (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Broadmeadow, New South Wales
Novartis Investigative Site, Maroochydore, Queensland
Novartis Investigative Site, Woodville South, South Australia
Novartis Investigative Site, Hobart, Tasmania
Novartis Investigative Site, Malvern East, Victoria
Novartis Investigative Site, Christchurch,
Novartis Investigative Site, St Leonards,
Novartis Investigative Site, Waikanae Beach,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
31 May 2021
Est. completion
29 September 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇮🇳 India 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in Cartilage Thickness in the Central Medial Tibiofemoral Compartment (cMTFC) of the Target Knee at Week 104

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov