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)

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

ClinicalTrials.gov Identifier: NCT04814368

Novartis Reference Number: CLNA043A12203

Last Update: Apr 28, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The study will establish safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

Condition 
Knee Osteoarthritis
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Aug 27, 2021
Completion date 
Apr 15, 2024
Gender 
All
Age(s)
40 Years - 80 Years (Adult, Older Adult)

Interventions

Biological
canakinumab
intra-articular injection (into the knee)
Biological
LNA043
intra-articular injection (into the knee)
Other
Placebo to canakinumab
intra-articular injection (into the knee)
Biological
canakinumab
intra-articular injection (into the knee)
Biological
LNA043
intra-articular injection (into the knee)
Other
Placebo to canakinumab
intra-articular injection (into the knee)
Biological
canakinumab
intra-articular injection (into the knee)
Biological
LNA043
intra-articular injection (into the knee)
Other
Placebo to canakinumab
intra-articular injection (into the knee)
Biological
canakinumab
intra-articular injection (into the knee)
Biological
LNA043
intra-articular injection (into the knee)
Other
Placebo to canakinumab
intra-articular injection (into the knee)

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 Locations

United States
Novartis Investigative Site
Recruiting
Clearwater, 33765
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89119
Nevada
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Clearwater, 33765
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89119
Nevada
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Clearwater, 33765
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89119
Nevada
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Clearwater, 33765
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89119
Nevada
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Czech Republic
Novartis Investigative Site
Recruiting
Pardubice, 530 02
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 19000
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Kolin, 280 02
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Novartis Investigative Site
Recruiting
Pardubice, 530 02
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 19000
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Kolin, 280 02
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Novartis Investigative Site
Recruiting
Pardubice, 530 02
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 19000
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Kolin, 280 02
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Novartis Investigative Site
Recruiting
Pardubice, 530 02
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Praha, 19000
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Kolin, 280 02
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Herne, 44649
-
Germany
Novartis Investigative Site
Recruiting
Herne, 44649
-
Germany
Novartis Investigative Site
Recruiting
Herne, 44649
-
Germany
Novartis Investigative Site
Recruiting
Herne, 44649
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]