Study Description
The study will establish safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
Interventions
canakinumab
LNA043
Placebo to canakinumab
Eligibility Criteria
Inclusion Criteria:
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) ≥2 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)
Exclusion Criteria:
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
Study Location
Novartis Investigative Site
Recruiting
Kecskemet,Bacs Kiskun,6044,Hungary
Novartis Investigative Site
Recruiting
Budapest,1036,Hungary
Novartis Investigative Site
Recruiting
Zalaegerszeg,8900,Hungary
Novartis Investigative Site
Recruiting
Krakow,31-501,Poland
Novartis Investigative Site
Recruiting
Warszawa,00-215,Poland
Novartis Investigative Site
Recruiting
Gliwice,44100,Poland
Novartis Investigative Site
Recruiting
Las Vegas,Nevada,89119,United States
Novartis Investigative Site
Recruiting
Morehead City,North Carolina,28557,United States
Novartis Investigative Site
Recruiting
Sunrise,Florida,33351,United States
Novartis Investigative Site
Recruiting
Clearwater,Florida,33765,United States
Worldwide Contacts
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