Status:
TERMINATED
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)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).
Detailed Description
This was a non-confirmatory, randomized, four arm, placebo-controlled, participant-, investigator and sponsor-blinded study in participants with symptomatic knee OA with synovial inflammation.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04814368
Start Date
August 27 2021
End Date
June 24 2024
Last Update
October 24 2025
Active Locations (11)
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1
Horizon Clinical Research
La Mesa, California, United States, 91942
2
Clinical Res Of W Florida
Clearwater, Florida, United States, 33765
3
Precision Clinical Research LLC
Sunrise, Florida, United States, 33351
4
LV Research
Las Vegas, Nevada, United States, 89119