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Anti-inflammatory
Canakinumab + LNA043 for Knee Osteoarthritis
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 15, 29, 43, 57, 71, 85, 197 and 365
Awards & highlights
Study Summary
This trial will test if canakinumab and LNA043 are safe and effective treatments for knee osteoarthritis.
Who is the study for?
This trial is for adults with moderate to severe knee pain from osteoarthritis, confirmed by specific clinical and imaging criteria. Participants must have had consistent pain over the last 3 months and show inflammation markers in their blood. They can't join if they've had recent knee surgery, plan a knee replacement, suffer from other inflammatory diseases or have significant misalignment in their knees.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of two drugs: Canakinumab (anti-inflammatory) and LNA043 (cartilage stimulating), injected into the knee. It will compare these treatments against a placebo to see which is better at reducing osteoarthritis symptoms.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression by Canakinumab, and possible unknown risks since LNA043 is newer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee MRI shows I have moderate to severe inflammation.
Select...
My knee arthritis is moderate to severe, with specific joint space measurements.
Select...
I have had moderate to severe knee pain most days in the last 3 months.
Select...
My knee pain score is below 60.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 15, 29, 43, 57, 71, 85, 197 and 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 15, 29, 43, 57, 71, 85, 197 and 365
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale
Change in cartilage volume in the index region measured by MRI
Secondary outcome measures
ANGPTL3 serum concentrations
ANGPTL3 synovial fluid concentrations
Anti-LNA043 antibodies in serum
+9 moreSide effects data
From 2018 Phase 3 trial • 31 Patients • NCT0233474835%
Nasopharyngitis
29%
Arthralgia
23%
Gastroenteritis
23%
Pyrexia
19%
Abdominal pain
13%
Conjunctivitis
13%
Rhinitis
13%
Influenza
13%
Tonsillitis
13%
Pain in extremity
13%
Paronychia
13%
Pharyngitis
13%
Tracheitis
13%
Viral infection
13%
Headache
13%
Eczema
13%
Diarrhoea
10%
Back pain
10%
Asthenia
10%
Bronchitis
10%
Juvenile idiopathic arthritis
10%
Cough
10%
Lymphadenopathy
6%
Scoliosis
6%
Myalgia
6%
Tendon pain
6%
Labyrinthitis
6%
Molluscum contagiosum
6%
Musculoskeletal pain
6%
Neck pain
6%
Onychomycosis
6%
Oral herpes
6%
Iron deficiency
6%
Sinusitis
6%
Ligament sprain
6%
Limb injury
6%
Arthritis
6%
Pain in jaw
6%
Skin papilloma
6%
Dermatitis allergic
6%
Dry skin
6%
Rash
6%
Abdominal pain upper
6%
Mouth ulceration
6%
Nausea
6%
Toothache
3%
Histiocytosis haematophagic
3%
Epstein-Barr virus infection
3%
Salmonellosis
3%
Intentional overdose
3%
Scar
3%
Bone disorder
3%
Hallucination, auditory
3%
Suicide attempt
3%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Canakinumab (ACZ885)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: canakinumab + LNA043Experimental Treatment2 Interventions
canakinumab + LNA043
Group II: canakinumabExperimental Treatment1 Intervention
canakinumab
Group III: LNA043Experimental Treatment2 Interventions
Placebo to canakinumab + LNA043
Group IV: PlaceboPlacebo Group1 Intervention
Placebo to canakinumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
canakinumab
2014
Completed Phase 3
~280
LNA043
2015
Completed Phase 2
~190
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,705 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,550 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a hip replacement or will have one soon.My knee MRI shows I have moderate to severe inflammation.I have had or plan to have knee surgery, including replacement or other procedures, within the past year.I have a condition like rheumatoid arthritis or lupus.My knee arthritis is moderate to severe, with specific joint space measurements.My knee is significantly misaligned.I have had moderate to severe knee pain most days in the last 3 months.I have had moderate to severe knee pain most days in the last 3 months.My knee pain score is below 60.
Research Study Groups:
This trial has the following groups:- Group 1: LNA043
- Group 2: Placebo
- Group 3: canakinumab + LNA043
- Group 4: canakinumab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the literature on canakinumab contain other research?
"Canakinumab is being researched in 16 different clinical trials, three of which are currently in Phase 3. Although the majority of these studies originate from Houston, Texas, 598 locations across the globe are running research for this medication."
Answered by AI
Can you share what indications are most appropriate for canakinumab?
"Canakinumab has been proven an effective treatment for muckle-wells syndrome (MWS), active systemic juvenile idiopathic arthritis, and neonatal-onset multisystem inflammatory disease (NOMID)."
Answered by AI
How many test subjects are involved in this research?
"The clinical trial is recruiting for 138 participants at 4 locations."
Answered by AI
How can I get involved in this clinical trial?
"The ideal candidate for this study would present with knee pain and be between the ages of 40-80. So far, 138 patients have been enrolled in the trial."
Answered by AI
Does this research project allow senior citizens to participate?
"This particular trial is meant for patients that are between 40 and 80 years of age. Out of the 748 total trials, 41 are designed for those under 18 while 706 are meant for elderly individuals."
Answered by AI
Could you please tell me how many test facilities are participating in this research project?
"There are 4 locations where this trial is recruiting patients: Sunrise, Las Vegas, Morehead City and ____. To make the process easier on potential enrollees, it is best to choose the medical facility that is closest to your location."
Answered by AI
Are volunteers still being accepted for this research project?
"The trial is presently looking for 138 patients from 4 locations, according to the information available on clinicaltrials.gov. This data also reveals that the trial was first posted on 8/27/2021 and was most recently edited on 11/18/2022."
Answered by AI
Canakinumab: is it more harmful than helpful?
"There is some data suggesting canakinumab is safe, but none indicating that it is an effective medication. Therefore, it received a score of 2."
Answered by AI
Who else is applying?
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I am interested in Clinical Trials for Osteo Arthritis because I'm not able to take anti-inflammatory prescription and otc pain treatments like Naproxen due to my taking Eliquis. Ibuprofen doesn't provide adequate pain management for my knees as well as the osteo pain in my shoulders, mid and lower back, hips, etc.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
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