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TerminatedPhase 2

A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Clearwater, La Mesa, Las Vegas, Morehead City, and Sunrise, United StatesSee the 5 sitesAlso in 5 other countries, 6 sites
Trial code
Status
Terminated
Phase
Phase 2
People taking part
23 people enrolled
Started
27 Aug 2021
Ended
24 Jun 2024
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • canakinumab
  • LNA043
  • Placebo to canakinumab
Record updated
24 October 2025
Why it stopped
Sponsor Decision

Who can take part

Age
40 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening
  • KOOS pain subscale <60 for the target knee during Screening
  • High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L
  • Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
  • Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)

Who cannot take part

  • History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy
  • Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
  • Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period
  • Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
  • Malalignment >7.5° in the target knee (either varus or valgus)

Where in United States

Also in 5 other countries, 6 sites

  • Clinical Res Of W FloridaClearwater, United States
  • Horizon Clinical ResearchLa Mesa, United States
  • LV ResearchLas Vegas, United States
  • Lucas ResearchMorehead City, United States
  • Precision Clinical Research, LLCSunrise, United States

About the trial

What the trial wants to find out

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

The 4 groups in the trial

  • Placebo+LNA043Treatment being tested

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

    Treatment: LNA043 and Placebo to canakinumab

  • PlaceboPlacebo, for comparison

    Placebo to canakinumab on Day 1

    Treatment: Placebo to canakinumab

  • canakinumab + LNA043Treatment being tested

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

    Treatment: canakinumab and LNA043

  • canakinumabTreatment being tested

    Canakinumab on Day 1

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis
Record updated
24 October 2025