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RNA-based Therapeutics
LNA043 for Osteoarthritis
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 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose
Awards & highlights
Study Summary
This trial will test a new medication to see if it is effective in regenerating cartilage in patients with knee problems.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to end of post treatment follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of post treatment follow-up
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 Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A
Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A
Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A
+3 moreSecondary outcome measures
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Superficial Part B
+11 moreSide effects data
From 2022 Phase 2 trial • 142 Patients • NCT032750647%
Arthralgia
5%
Joint effusion
5%
Muscle strain
5%
Upper respiratory tract infection
5%
Neck pain
2%
Odontogenic cyst
2%
Back pain
2%
Bone contusion
2%
Osteoarthritis
2%
Procedural pain
2%
Chondropathy
2%
Epicondylitis
2%
Nasopharyngitis
2%
Tonsillitis
2%
Varicose vein
2%
Nail injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Part B - TE
LNA043 20 mg Part A - FU
Placebo Part A - FU
LNA043 20 mg Part B - FU
LNA043 20 mg Part B - TE
LNA043 40 mg Part B - FU
Placebo Part A - TE
LNA043 20 mg Part A - TE
Placebo Part B - FU
LNA043 40 mg Part B - TE
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: LNA043 40 mg Part BExperimental Treatment1 Intervention
LNA043 40 mg Part B
Group II: LNA043 20 mg Part BExperimental Treatment1 Intervention
LNA043 20 mg Part B
Group III: LNA043 20 mg Part AExperimental Treatment1 Intervention
LNA043 20 mg Part A
Group IV: Placebo Part BPlacebo Group1 Intervention
Placebo Part B
Group V: Placebo Part APlacebo Group1 Intervention
Placebo Part A
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
2,858 Previous Clinical Trials
4,197,701 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,546 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
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