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Antisense Oligonucleotide

LNA043 for Total Knee Replacement Surgery

Phase 1
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 pre-dose, day 1, day 4, day 8, and day 36
Awards & highlights

Summary

This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.

Eligible Conditions
  • Total Knee Replacement Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, day 1, day 4, day 8, and day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, day 1, day 4, day 8, and day 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Electrocardiogram
Secondary study objectives
Concentration of ANGPTL in serum and synovial fluid
Concentration of LNA043 in serum and synovial fluid
Immunohistochemical staining for LNA043 in knee cartilage
+1 more

Side effects data

From 2022 Phase 2 trial • 142 Patients • NCT03275064
7%
Arthralgia
5%
Muscle strain
5%
Neck pain
5%
Joint effusion
5%
Upper respiratory tract infection
2%
Epicondylitis
2%
Back pain
2%
Tonsillitis
2%
Procedural pain
2%
Nail injury
2%
Chondropathy
2%
Osteoarthritis
2%
Odontogenic cyst
2%
Varicose vein
2%
Nasopharyngitis
2%
Bone contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
LNA043 20 mg Part A - FU
Placebo Part B - FU
LNA043 20 mg Part A - TE
Placebo Part A - FU
LNA043 40 mg Part B - TE
Placebo Part A - TE
LNA043 20 mg Part B - FU
LNA043 40 mg Part B - FU
Placebo Part B - TE
LNA043 20 mg Part B - TE

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LNA043Experimental Treatment1 Intervention
LNA043 given intra-articularly
Group II: PlaceboPlacebo Group1 Intervention
Placebo given intra-articularly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LNA043
2015
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,895 Previous Clinical Trials
4,201,436 Total Patients Enrolled
~3 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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