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Antisense Oligonucleotide
LNA043 for Knee Osteoarthritis (ONWARDS Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 104
Awards & highlights
ONWARDS Trial Summary
This trial will help find the best dose of the drug LNA043 for people with knee osteoarthritis.
Eligible Conditions
- Osteoarthritis
ONWARDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
Secondary outcome measures
Assessing percentage of participants with adverse events and serious adverse events
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.
+5 moreONWARDS Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: LNA043 Dosing Regimen DExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen D
Group II: LNA043 Dosing Regimen CExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen C
Group III: LNA043 Dosing Regimen BExperimental Treatment1 Intervention
LNA04 injection to the knee with dosing regimen B
Group IV: LNA043 Dosing Regimen AExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen A
Group V: PlaceboPlacebo Group1 Intervention
Injection to the knee
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,198,745 Total Patients Enrolled
12 Trials studying Osteoarthritis
1,993 Patients Enrolled for Osteoarthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a diagnosis of primary knee OA by standard American College of Rheumatology clinical and radiographic criteria.There may be additional requirements for participation that are outlined in the study plan.You are between 40 and 75 years of age.You have a body mass index (BMI) of less than 40 kg/m2.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: LNA043 Dosing Regimen A
- Group 3: LNA043 Dosing Regimen B
- Group 4: LNA043 Dosing Regimen C
- Group 5: LNA043 Dosing Regimen D
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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04864392 — Phase 2
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