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)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Knee Osteoarthritis
In brief
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
Key facts
- Study ID
- NCT04814368
- Run by
- Novartis Pharmaceuticals
- People needed
- 23
- Starts
- 2021-08-27
- Expected to finish
- 2024-06-24
- Last updated by the study team
- 2025-10-24
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- Malalignment >7.5° in the target knee (either varus or valgus)
- 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)
- 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
Where it is running
- Horizon Clinical Research — La Mesa, California, United States
- Clinical Res Of W Florida — Clearwater, Florida, United States
- Precision Clinical Research LLC — Sunrise, Florida, United States
- LV Research — Las Vegas, Nevada, United States
- Lucas Research — Morehead City, North Carolina, United States
- Novartis Investigative Site — Prague, Czech Republic, Czechia
- Novartis Investigative Site — Tartu, Estonia
- Novartis Investigative Site — Kecskemét, Bács-Kiskun county, Hungary
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Riga, Latvia
- Novartis Investigative Site — Warsaw, Poland
Full record on ClinicalTrials.gov
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